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- albumin-bound paclitaxel / Generic mfg.
Sequential neoadjuvant chemotherapy for borderline resectable and locally advanced pancreatic adenocarcinoma. (Hall A; Poster Bd #: 174b) - Apr 24, 2024 - Abstract #ASCO2024ASCO_3938;
P2
Current guidelines suggest modified FOLFIRINOX (mFFX, infusional 5-fluorouracil, oxaliplatin, irinotecan) or GA as the first-line systemic chemotherapeutic regimen in neoadjuvant, adjuvant and palliative setting...These results will have high translational potential for providing mechanistic insight into tumor response, optimizing current management strategies for pancreatic cancer that could be generalizable to other stages of this cancer. The key eligibility criteria include treatment naive histologically diagnosed BRPC or LAPC with measurable disease, ECOG 0,1, optimal organ function.
- 5-fluorouracil / Generic mfg.
METAPANC, intensified treatment in patients with oligometastatic pancreatic cancer: Multimodal surgical treatment versus systemic chemotherapy alone (Hall A; Poster Bd #: 173b) - Apr 24, 2024 - Abstract #ASCO2024ASCO_3936;
METAPANC is a prospective randomized controlled multicenter phase III trial evaluating survival and quality of life after multimodal therapy with perioperative modified FOLFIRINOX (mFFX) chemotherapy (two times 4 cycles prior to resection of the primary tumor and resection of the metastases), followed by 4 cycles of adjuvant mFFX chemotherapy (Arm A) vs. mFFX (without surgery), as standard of care first-line treatment (Arm B)...22 German participating sites are selected. Further international sites are planned in the Netherlands, Norway, Finland and Sweden.
- ivaltinostat IV (CG-745) / CG Invites
A randomized, multi-center, phase 2 study of ivaltinostat (Ival) plus capecitabine (Cape) versus capecitabine alone in the maintenance setting in patients with metastatic pancreatic adenocarcinoma (mPDAC). (Hall A; Poster Bd #: 173a) - Apr 24, 2024 - Abstract #ASCO2024ASCO_3935;
P1/2
Background: Front-line chemotherapy for patients (pts) with advanced or mPDAC typically consists of mFOLFIRINOX or gemcitabine/nab-paclitaxel given until disease progression or intolerable toxicity...Enrollment in the phase 2 study began in January 2024 across multiple sites in the US. Accrual is anticipated to complete 4Q2024.
- albumin-bound paclitaxel / Generic mfg.
Alliance A022106: A phase II/III trial of NABPLAGEM vs nab-paclitaxel/gemcitabine as second-line treatment for BRCA1/2 or PALB2 mutant metastatic pancreatic ductal adenocarcinoma (PLATINUM). (Hall A; Poster Bd #: 172b) - Apr 24, 2024 - Abstract #ASCO2024ASCO_3934;
P2/3
While oxaliplatin, part of the FOLFIRINOX regimen, represents the most commonly used platinum analogue for PDAC, clinical data shows that cisplatin (in combination with gemcitabine) can produce robust response rates (~70%) specifically in patients with germline BRCA/PALB2-mutated metastatic PDAC...Planned correlatives include ctDNA analysis for BRCA reversion mutations in all patients, as well as whole genome and transcriptome sequencing in an optional biopsy cohort. This study was activated in December 2023.
- Tecentriq (atezolizumab) / Roche, Reolysin (pelareorep) / Oncolytics, Andrus Reo
Phase 1/2 randomized, open-label, multicenter, Simon two-stage study of pelareorep combined with modified FOLFIRINOX +/- atezolizumab in patients with metastatic pancreatic ductal adenocarcinoma. (Hall A; Poster Bd #: 171b) - Apr 24, 2024 - Abstract #ASCO2024ASCO_3932;
Secondary objectives include duration of response, progression-free survival, and overall survival. In addition, tumor and blood samples are being collected to evaluate the immunological effects of treatment and to explore potential biomarkers of response.
- Mektovi (binimetinib) / Ono Pharma, Pierre Fabre, Pfizer
Alliance EAY191-A6: FOLFOX in combination with binimetinib as second-line therapy for patients with advanced biliary tract cancers (BTCs) with MAPK pathway alterations: A ComboMATCH treatment trial. (Hall A; Poster Bd #: 168a) - Apr 24, 2024 - Abstract #ASCO2024ASCO_3925;
P2
Gemcitabine and cisplatin (GC) with or without immunotherapy are often used as 1 st -line therapies...mFOLFOX6 (5-fluorouracil [5-FU], leucovorin [LV], oxaliplatin) or liposomal irinotecan+5-FU+LV are options when no biomarkers are found (e.g., MSI-H, BRAFV600E, FGFR-fusions, IDH1-mutation, HER2-overexpression).Prior studies do not demonstrate benefit with MEK inhibitors (MEKi), but none of the studies had biomarker selection...Exploratory objectives include prognostic modeling, correlations of genomic alterations with response or resistance and use of machine learning for outcome prediction. This study is active and open to accrual.
- AiTan (rivoceranib) / HLB Bio Group, AiRuiKa (camrelizumab) / HLB Bio Group
Apatinib and camrelizumab plus hepatic arterial infusion with oxaliplatin and 5-fluorouracil vs. apatinib and camrelizumab as the first-line treatment for hepatocellular carcinoma with portal vein tumor thrombus: A randomized multi-center clinical trial. (Hall A; Poster Bd #: 167a) - Apr 24, 2024 - Abstract #ASCO2024ASCO_3923;
P3
Secondary endpoints were progression-free survival, objective response rate per RECIST 1.1 and mRECIST, disease control rate per RECIST 1.1 and mRECIST, time to progression, duration of response, time to response, and safety. Whole-Exome Sequencing and RNA Sequencing of tumor biopsy samples were performed for predictive biomarker exploration.
- AiTan (rivoceranib) / HLB Bio Group, AiRuiKa (camrelizumab) / HLB Bio Group
Apatinib and camrelizumab plus Intravenous FOLFOX or hepatic arterial infusion chemotherapy with FOLFOX for advanced HCC: A multicenter, prospective, randomized phase III trial. (Hall A; Poster Bd #: 166b) - Apr 24, 2024 - Abstract #ASCO2024ASCO_3922;
P2, P3
Allowing a dropout rate of 15%, we aimed to enroll 192 patients. The trial is currently screening eligible patients.
- GEMINI-Gastric: A phase 2 study of novel treatment combinations in patients with locally advanced unresectable or metastatic gastric cancers. (Hall A; Poster Bd #: 161a) - Apr 24, 2024 - Abstract #ASCO2024ASCO_3911;
P2
Sample sizes have been selected to provide adequate precision for the primary endpoints. The study is currently recruiting at sites in the US, Europe, and Asia.
- Bylantra (devimistat) / Cornerstone Pharma, Ono Pharma
A phase I/II open-label clinical trial of CPI-613 in combination with modified FOLFIRINOX in patients with locally advanced (LAPC) or borderline resectable pancreatic cancer (BRPC). (Hall A; Poster Bd #: 152) - Apr 24, 2024 - Abstract #ASCO2024ASCO_3901;
P1/2
The study is currently recruiting at sites in the US, Europe, and Asia. The combination of mFOLFIRINOX and D is feasible in the LAPC/BRPC population at increased dose levels of D; however, it did not meet the primary endpoint of doubling OS compared to historical controls.
- Extracellular (EC) Mucin5AC (MUC5AC) detection after neoadjuvant therapy (NAT) and the risk of recurrence in resected pancreatic ductal adenocarcinoma (R-PDA). (Hall A; Poster Bd #: 151) - Apr 24, 2024 - Abstract #ASCO2024ASCO_3900;
Post NAT EC-MM detection and cellular MUC5AC (MM and IM) expression levels are associated with worse PFS and pathological features. Their role in the treatment of na
- peposertib (M3814) / EMD Serono
ETCTN 10366: A phase 1 study of DNA-PK inhibitor peposertib in combination with hypofractionated radiotherapy for the treatment of locally advanced pancreatic adenocarcinoma. (Hall A; Poster Bd #: 148) - Apr 24, 2024 - Abstract #ASCO2024ASCO_3897;
P1/2
Peposertib 300 mg daily x 14 days in combination with SBRT at a dose of 8 Gy x 5 fractions is the recommended phase 2 dose. A randomized phase 2 study is now enrolling to further assess the efficacy of the combination in patients with LAPC.
- 5-fluorouracil / Generic mfg., leucovorin calcium / Generic mfg., irinotecan / Generic mfg.
Neoadjuvant therapy in patients with pancreatic ductal adenocarcinoma (PDAC) with germline DNA damage repair (DDR) mutations: A dual institution retrospective study. (Hall A; Poster Bd #: 144) - Apr 24, 2024 - Abstract #ASCO2024ASCO_3893;
This study demonstrated that patients with resectable, BR or LA-PDAC with germline DDR mutations have a significantly prolonged DFS and OS and increased complete or near complete pathologic response rates. This suggests increased benefit from neoadjuvant therapy across all potentially resectable patients with germline DDR mutations.
- Neoadjuvant fractionated versus hypofractionated chemoradiotherapy in resectable and borderline resectable pancreatic cancer. (Hall A; Poster Bd #: 141) - Apr 24, 2024 - Abstract #ASCO2024ASCO_3890;
Following a shift to HypoFxRT, no apparent compromise in pathologic tumor response, durability of local control, or survival was observed. This data supports the continued use of HypoFxRT within the neoadjuvant Pca treatment paradigm as more convenient alternatives to ConvFracRT.
- 5-fluorouracil / Generic mfg., leucovorin calcium / Generic mfg., irinotecan / Generic mfg.
Comparative effectiveness of NALIRIFOX vs. FOLFIRINOX in pancreatic cancer. (Hall A; Poster Bd #: 140) - Apr 24, 2024 - Abstract #ASCO2024ASCO_3889;
The analysis highlights the importance of AE management for improving quality of life and cost in the recipients of FOLFIRINOX. The economic value for use of NALIRIFOX is very high and outside of any conventional boundary of acceptable value threshold for treatment.
- Lynparza (olaparib) / Merck (MSD), AstraZeneca
Post-progression therapies and outcomes for patients with advanced, BRCA-related pancreatic cancer after receipt of PARP inhibitors: A national retrospective cohort study. (Hall A; Poster Bd #: 136) - Apr 24, 2024 - Abstract #ASCO2024ASCO_3886;
Further work will be needed to identify mechanisms of resistance to PARPi and to optimize post-progression treatments. This work adds to a growing body of literature supporting an individualized approach to post-progression therapy decisions for these patients.
- 5-fluorouracil / Generic mfg., leucovorin calcium / Generic mfg., irinotecan / Generic mfg.
Integrated genomic and transcriptomic analysis to predict FOLFIRINOX response in metastatic pancreatic ductal adenocarcinoma. (Hall A; Poster Bd #: 133) - Apr 24, 2024 - Abstract #ASCO2024ASCO_3883;
This work adds to a growing body of literature supporting an individualized approach to post-progression therapy decisions for these patients. We found that KRAS wild-type tumors do not fit in the classical
- albumin-bound paclitaxel / Generic mfg.
GATA6 expression in advanced pancreatic ductal adenocarcinoma (PDAC) as a prognostic and predictive biomarker in the Canadian COMPASS trial and the Comprehensive Cancer Center, Fondazione Policlinico Universitario Agostino Gemelli IRCCS. (Hall A; Poster Bd #: 130) - Apr 24, 2024 - Abstract #ASCO2024ASCO_3880;
P
We did not find an association with tumor location, which also was not prognostic in this study. Importantly GATA6 was predictive of survival in patients receiving mFFX, suggesting GATA6 low tumors should receive 1 st line GnP based regimens.
- 5-fluorouracil / Generic mfg., leucovorin calcium / Generic mfg., irinotecan / Generic mfg.
Primary prophylaxis with pegylated-granulocyte colony-stimulating factor for patients with unresectable pancreatic cancer treated with modified-FOLFIRINOX: A randomized phase II trial. (Hall A; Poster Bd #: 125) - Apr 24, 2024 - Abstract #ASCO2024ASCO_3875;
Considering the study design of permitting the crossover, cumulative RDI was similar. Further follow-up of survival and quality of life results will be presented.
- Opdivo (nivolumab) / BMS
Interim results of the randomized phase 2 cohort of study FW-2020-01 assessing the efficacy, safety and pharmacodynamics of CM24 in combination with nivolumab and chemotherapy in advanced/metastatic pancreatic cancer. (Hall A; Poster Bd #: 123) - Apr 24, 2024 - Abstract #ASCO2024ASCO_3873;
P1/2
The interim analysis suggests that the combination of CM24/nivo/Nal-IRI/5FU/LV has a manageable safety profile with a longer PFS supported by higher ORR and DCR. OS Data continues to mature and will be reported once available.
- irinotecan liposomal / CSPC Pharma
A randomised phase 2 study of liposomal irinotecan in combination with 5-fluorouracil/leucovorin and oxalipalatin versus nab-paclitaxel plus gemcitabine in unresectable locally advanced or metastatic pancreatic cancer. (Hall A; Poster Bd #: 121) - Apr 24, 2024 - Abstract #ASCO2024ASCO_3871;
P2
OS Data continues to mature and will be reported once available. Patients with unresectable locally advanced or metastatic pancreatic cancer were randomly assigned (2:1) to receive NALIRIFOX (HE072 50 mg/m
- albumin-bound paclitaxel / Generic mfg.
NALIRIFOX versus nab-paclitaxel and gemcitabine in treatment-na (Hall A; Poster Bd #: 116) - Apr 24, 2024 - Abstract #ASCO2024ASCO_3866;
P3
In this 29-month follow-up of NAPOLI 3, NALIRIFOX continued to demonstrate improved OS compared with Gem+NabP, with 11 patients still receiving the NALIRIFOX regimen. These data confirm NALIRIFOX as a new possible standard of care and reference regimen for the first-line treatment of patients with mPDAC.
- Onivyde (nanoliposomal irinotecan) / Servier, Ipsen
The clinical utility of plasma cell-free DNA (cfDNA) in NET-02: Randomised, phase II trial of liposomal irinotecan (nal-IRI)/5-fluorouracil (5-FU)/folinic acid or docetaxel as second-line (2L) therapy in patients (pts) with progressive poorly differentiated extra-pulmonary neuroendocrine carcinoma (PD-EP-NEC). (Hall A; Poster Bd #: 110) - Apr 24, 2024 - Abstract #ASCO2024ASCO_3860;
1. McNamara 2023, EClin Med.
- BOLD-100 / Bold Therap
A phase 2 study of BOLD-100 in combination with FOLFOX chemotherapy in patients with pretreated advanced biliary tract cancer: Efficacy and safety analysis (BOLD-100-001). (Hall A; Poster Bd #: 95) - Apr 24, 2024 - Abstract #ASCO2024ASCO_3845;
P1b/2a
There were no new safety signals detected. The mPFS, mOS, ORR and DCR data in this advanced BTC cancer population indicate a treatment combination worthy of further study for this difficult to treat cancer.
- AiTan (rivoceranib) / HLB Bio Group, AiRuiKa (camrelizumab) / HLB Bio Group
Updated results from venous infusion chemotherapy (VIC) plus apatinib and camrelizumab for hepatocellular carcinoma (HCC) in CNLC stage III: A prospective, single-arm, phase II trial. (Hall A; Poster Bd #: 92) - Apr 24, 2024 - Abstract #ASCO2024ASCO_3843;
P2
HCC, the new VIC-triplet treatment system demonstrated acceptable safety and the same anti-tumor effects as HAIC plus antiangiogenic drugs and PD-(L)1 inhibitors, especially in those with VP4. These findings provided new insights for treatment of advanced HCC and a relevant clinical phase 3 study was underway.
- Keytruda (pembrolizumab) / Merck (MSD)
Neoadjuvant/adjuvant pembrolizumab (pembro) + chemotherapy (chemo) vs placebo (pbo) + chemo for gastric/gastroesophageal junction (G/GEJ) adenocarcinoma: Major pathologic response (mPR) in KEYNOTE-585. (Hall A; Poster Bd #: 53) - Apr 24, 2024 - Abstract #ASCO2024ASCO_3804;
P3
In this post hoc analysis, pts with mPR had numerically improved PFS and OS with pembro + chemo vs pbo + chemo; these findings were consistent with analysis of the ITT population. Further studies in this population are warranted.
- Opdivo (nivolumab) / BMS
Multicenter randomized phase II study of short course FOLFOX + nivolumab (Nivo) followed by maintenance Nivo +/- radiation (RT) in the first line treatment of metastatic or unresectable gastroesophageal adenocarcinoma (mGEA). (Hall A; Poster Bd #: 40) - Apr 24, 2024 - Abstract #ASCO2024ASCO_3793;
P2
Patients who receive short course chemotherapy can successfully be rechallenged with oxaliplatin. The addition of RT to maintenance Nivo does not improve CPI efficacy.
- BOLD-100 / Bold Therap
A phase 2 study of BOLD-100 in combination with FOLFOX chemotherapy in patients with advanced gastric cancer: Efficacy and safety analysis (BOLD-100-001). (Hall A; Poster Bd #: 39) - Apr 24, 2024 - Abstract #ASCO2024ASCO_3792;
P1b/2a
The reported mPFS, mOS, ORR and DCR data in this analysis shows promising clinical activity. The combination of BOLD-100 with FOLFOX is worthy of further study.
- Opdivo (nivolumab) / BMS, Stivarga (regorafenib) / Bayer
First-line regorafenib with nivolumab and FOLFOX or CapeOX in patients with advanced gastric, gastroesophageal junction, and esophageal adenocarcinoma: A single-arm, phase Ib/II trial (REGONIVOCTx, EPOC2104). (Hall A; Poster Bd #: 32) - Apr 24, 2024 - Abstract #ASCO2024ASCO_3785;
P1/2
The results of biomarker analysis will be presented. A randomized, phase III trial is planned.
- Opdivo (nivolumab) / BMS
Nivolumab (NIVO) + chemotherapy (chemo) vs chemo as first-line (1L) treatment for advanced gastric cancer/gastroesophageal junction cancer/esophageal adenocarcinoma (GC/GEJC/EAC): 4-year follow-up of CheckMate 649. (Hall A; Poster Bd #: 20) - Apr 24, 2024 - Abstract #ASCO2024ASCO_3773;
P3
NIVO + chemo is the first PD-1 inhibitor/chemo combination to demonstrate long-term efficacy and acceptable safety after 4 yrs of follow up in previously untreated advanced GC/GEJC/EAC. These results are consistent with earlier follow-ups, further supporting NIVO + chemo as a standard 1L treatment in these pts.
- Vyloy (zolbetuximab) / Astellas
Final overall survival results from phase 3 SPOTLIGHT study evaluating zolbetuximab + mFOLFOX6 as first-line (1L) treatment for patients (pts) with claudin 18 isoform 2 (CLDN18.2)+, HER2?, locally advanced (LA) unresectable or metastatic gastric or gastroesophageal junction (mG/GEJ) adenocarcinoma. (Hall A; Poster Bd #: 16) - Apr 24, 2024 - Abstract #ASCO2024ASCO_3770;
P3
Background: The phase 3 SPOTLIGHT study showed statistically significant improvements in progression-free survival (PFS) and overall survival (OS) with 1L zolbetuximab + modified folinic acid, 5-FU, and oxaliplatin regimen (mFOLFOX6) vs placebo (PBO) + mFOLFOX6 in pts with CLDN18.2+, HER2?, LA unresectable or mG/GEJ adenocarcinoma at prespecified interim and later updated analyses... Zolbetuximab + mFOLFOX6 continued to demonstrate statistically significant and clinically meaningful improvement in PFS and OS vs PBO + mFOLFOX6, with no new safety signals
- 5-fluorouracil / Generic mfg.
Prospective randomized multicenter phase III trial comparing perioperative chemotherapy (FLOT protocol) to neoadjuvant chemoradiation (CROSS protocol) in patients with adenocarcinoma of the esophagus (ESOPEC trial). (Hall B1) - Apr 24, 2024 - Abstract #ASCO2024ASCO_3241;
P3
Perioperative FLOT improves survival in resectable EAC compared to neoadjuvant CROSS. Funding: The trial was funded by the Deutsche Forschungsgemeinschaft (DFG, German Research Foundation), project number 264590883.
- mitazalimab (ADC-1013) / Alligator Biosci
CD4 effector T cell expansion to identify objective responses to the CD40 agonist mitazalimab in combination with modified FOLFIRINOX (mFFX) as first-line therapy for metastatic pancreatic ductal adenocarcinoma (mPDAC) in the OPTIMIZE-1 study. (Hall A; Poster Bd #: 48) - Apr 24, 2024 - Abstract #ASCO2024ASCO_2972;
P1/2
Pharmacological analyses identify mitazalimab-induced expansion of CD4 effector T cells one week after first administration as a correlate of treatment outcomes. These data suggest the contribution of mitazalimab to tumor responses, and further substantiate a priming dose of mitazalimab, prior to administering chemotherapy.
- Neurapeg (pegteograstim) / Green Cross Cell
Comparison of prophylactic effects for chemotherapy-induced neutropenia between same-day vs next-day administration of pegteograstim in chemotherapy regimen composed of day 1 intensive myelosuppressive agent: A randomized phase III trial (CONCISE, KCSG PC22-11). (Hall A; Poster Bd #: 276b) - Apr 24, 2024 - Abstract #ASCO2024ASCO_2896;
Background: Administration of peg-GCSF 24 to 72 hours after chemotherapy is usually recommended...Patients with adjuvant/neoadjuvant or 1st palliative chemotherapy comprising intensively myleosuppressive agents on day 1 (mFOLFIRINOX, ECb, EP, FOLFIRI, and FOLFOX) are enrolled...This results in the need for a total of 160 patients, 80 in each arm. We are currently recruiting patients (since Nov 2022).
- Frequency of certain germline polymorphisms among ethnicities and adverse drug reaction risk associated with colorectal cancer therapies. (Hall A; Poster Bd #: 248) - Apr 24, 2024 - Abstract #ASCO2024ASCO_2866;
In this large sample size, a 6% DPYD risk variant carrier frequency is significantly more than an estimated 2%, as previously reported. The FDA and CPIC provide clinically actionable recommendations for these commonly used colorectal and other gastrointestinal cancer therapies in an effort to avoid severe and even life-threatening toxicities that may be potentiated by these germline variations.
- etrumadenant (AB928) / Arcus Biosci, Gilead
ARC-9: A randomized study to evaluate etrumadenant based treatment combinations in previously treated metastatic colorectal cancer (mCRC). (Arie Crown Theater) - Apr 24, 2024 - Abstract #ASCO2024ASCO_2721;
P1/2
Further investigation of this promising regimen is warranted given the clinically meaningful PFS and OS improvement. Table
- Vectibix (panitumumab) / Amgen
FU/FA maintenance therapy with or without panitumumab (pmab) in RAS wild-type metastatic colorectal cancer (mCRC) (PanaMa, AIO KRK 0212): Updated efficacy analyses. (Arie Crown Theater) - Apr 24, 2024 - Abstract #ASCO2024ASCO_2719;
P2
PFS remained improved by the addition of pmab to FU/FA maintenance therapy, while OS was not significantly longer. Re-induction of pmab+mFOLFOX6 did not provide benefit following pmab maintenance regarding PFS.
- Avastin (bevacizumab) / Roche
Primary outcome analysis of the ORCHESTRA trial: A randomized phase III trial of additional tumor debulking to first-line palliative systemic therapy for patients with multiorgan metastatic colorectal cancer. (Arie Crown Theater) - Apr 24, 2024 - Abstract #ASCO2024ASCO_2713;
P=N/A
Re-induction of pmab+mFOLFOX6 did not provide benefit following pmab maintenance regarding PFS. Upon clinical benefit after 3 or 4 cycles of respectively capecitabine or 5-fluorouracil/leucovorin and oxaliplatin
- 5-fluorouracil / Generic mfg.
The NEO-RT trial: A phase 3 randomized trial of neoadjuvant chemotherapy, excision and observation versus chemoradiotherapy for early rectal cancer, CCTG CO.32. (Hall A; Poster Bd #: 301a) - Apr 24, 2024 - Abstract #ASCO2024ASCO_2709;
P3
The results of this study will have a major impact on the treatment of patients with stage I rectal cancer. Both arms offer the potential of organ preservation and results will inform whether induction chemotherapy is non-inferior to ChemoRT and compare patient QOL and functional outcomes.
- 5-fluorouracil / Generic mfg.
Adjuvant chemotherapy in clinical local advanced CRC following preoperational therapies and pT0-3N0M0 diagnosis (CANWATCH). (Hall A; Poster Bd #: 300b) - Apr 24, 2024 - Abstract #ASCO2024ASCO_2708;
P=N/A
Patients in the wait-and-watch group did not receive adjuvant chemotherapy but were followed up periodically, while patients in the adjuvant chemotherapy group continued to receive adjuvant chemotherapy based on 5-FU or 5-FU analogues (mFOLFOX6 or Capeox)...A total of 650 patients are planned to be enrolled in this study, and 301 patients have been enrolled as of February 6, 2024. The study is registered with ClinicalTrials.gov (NCT03748485) and is ongoing.
- Lonsurf (trifluridine/tipiracil) / Otsuka, Tukysa (tucatinib) / Pfizer, Herceptin (trastuzumab) / Roche
Use of circulating tumor DNA (ctDNA) to affect the adjuvant or post-adjuvant treatment of patients with stage III and high-risk stage II resected colon cancer: The ERASE-CRC project by GONO. (Hall A; Poster Bd #: 300a) - Apr 24, 2024 - Abstract #ASCO2024ASCO_2707;
P2
In the phase II ERASE-CRC Part 2 study, ctDNA-positive patients after the end of an oxaliplatin-based adjuvant therapy (either in the context or outside ERASE-CRC Part 1 or ERASE-HER2) are randomized 1:2 to observation (standard arm) or trifluridine/tipiracil for 6 cycles (experimental arm)...Currently, 19 and 8 patients have been randomized in ERASE-CRC Part 1 or 2, respectively. NCT05062889.
- 5-fluorouracil / Generic mfg., oxaliplatin / Generic mfg., leucovorin calcium / Generic mfg.
Adjuvant chemotherapy with mFOLFOXIRI versus mFOLFOX6 in MRD-positive stage II-III colorectal cancer. (Hall A; Poster Bd #: 299a) - Apr 24, 2024 - Abstract #ASCO2024ASCO_2705;
P3
NCT05062889. Patients were randomized (1:1) to receive mFOLFOXIRI (oxaliplatin 85 mg/m
- Stivarga (regorafenib) / Bayer
REPROGRAM-02: A phase II-III study evaluating an induction treatment with regorafenib and metronomic chemotherapy before the second line chemotherapy in metastatic colorectal cancer. (Hall A; Poster Bd #: 297b) - Apr 24, 2024 - Abstract #ASCO2024ASCO_2702;
P2, P2/3
Patients with mCRC in progression after a 1 st of chemotherapy, receive either (i) regorafenib (REDOS schedule: 80 mg for week 1, 120 mg for week 2 and 160 mg for week 3 of the first cycle) in combination with CT (capecitabine 625mg/m 2 twice daily and cyclophosphamide 50 mg daily) and low-dose aspirin (75 mg once daily) during 8 weeks as an induction therapy before chemotherapy initiation in the second-line, or (ii) the second line standard chemotherapy (FOLFOX or FOLFIRI with anti-VEGF until progression or unacceptable toxicity)...Assuming a significance level of 5% and a power of 80%, a sample size of 93 patients is needed for the phase II and 446 patients for the phase III. The enrollment is ongoing, 13 patients have already been recruited.
- telisotuzumab adizutecan (ABBV-400) / AbbVie, Avastin (bevacizumab) / Roche
Phase 2 randomized study evaluating safety, efficacy, and optimal dose of ABBV-400 in combination with fluorouracil, folinic acid, and bevacizumab in previously treated patients with metastatic colorectal cancer. (Hall A; Poster Bd #: 296a) - Apr 24, 2024 - Abstract #ASCO2024ASCO_2700;
P2
The enrollment is ongoing, 13 patients have already been recruited. ABBV-400 is a c-Met
- STC-1010 / Brenus Pharma
BreAK CRC, a first-in-human phase I/II trial of STC-1010, a new allogenic cancer vaccine for advanced or metastatic unresectable colorectal cancer. (Hall A; Poster Bd #: 295b) - Apr 24, 2024 - Abstract #ASCO2024ASCO_2699;
Preclinical efficacy and safety results of STC-1010 murine surrogate underline the capacity of the vaccine combined with immunostimulant in low dose (cyclophosphamide and GM-CSF) associated or not with the standard of care (SoC) chemotherapy (FOLFOX or FOLFIRI) to decrease tumor volume, improve mice survival and enhance tumor T cell infiltration in different syngeneic models of mice... The dose-escalation phase I will evaluate on 9 to 18 patients the tolerability of two STC-1010's dose levels (3x10 6 and 6x10 6 vaccine cells) administered intra-dermally on a weekly basis for 8 weeks, followed by 4 boosts, combined with immunostimulants in low dose (oral cyclophosphamide: 50 mg/day, 3 days before vaccine and GM-CSF: 125or 250
- Tecentriq (atezolizumab) / Roche
NRG-GI004/SWOG-S1610: Colorectal cancer metastatic dMMR immuno-therapy (COMMIT) study (Hall A; Poster Bd #: 294a) - Apr 24, 2024 - Abstract #ASCO2024ASCO_2696;
P3
Upon AtezoTRIBE subgroup analysis of the 8 pts with dMMR mCRC treated with FOLFOXIRI+bev+atezo, median PFS was not reached, with the first pt having progression ~16 mos...NCT02997228. Support: U10CA180868, -180822, -180888, UG1CA189867, U24CA196067; Genentech, Inc.
- 5-fluorouracil / Generic mfg., leucovorin calcium / Generic mfg.
Clinical validation of Histotype Px Colorectal in patients in a U.S. colon cancer cohort. (Hall A; Poster Bd #: 285) - Apr 24, 2024 - Abstract #ASCO2024ASCO_2688;
The findings from this study highlight the potential utility of this innovative biomarker in guiding clinical decisions regarding ACT. Further research involving a larger and more diverse patient cohort and subsequent clinical studies are planned to solidify these initial findings and to enable personalized treatment strategies based on individual risk assessments.
- 5-fluorouracil / Generic mfg.
Korean Society of Coloproctology trial of consolidation chemotherapy for locally advanced mid or low rectal cancer after neoadjuvant concurrent chemoradiotherapy: KONCLUDE multicenter radomized trial. (Hall A; Poster Bd #: 268) - Apr 24, 2024 - Abstract #ASCO2024ASCO_2672;
P3
The three cycles of modified FOLFOX 6 consolidation chemotherapy might not be enough to achieve pCR in advanced mid or low-rectal cancer patients. This trial justifies future trials with a total neoadjuvant therapy (TNT) strategy.
- Phase II trial of organ preservation program using short-course radiation and FOLFOXIRI for rectal cancer (SHORT-FOX). (Hall A; Poster Bd #: 263) - Apr 24, 2024 - Abstract #ASCO2024ASCO_2668;
P2
Short-course radiation followed by FOLFOXIRI was feasible and safe. In this high-risk cohort of pts with rectal cancer, 24.3% of pts had a cCR at time of primary assessment.
- Exploratory biomarker analysis for predicting treatment effects of aflibercept in the VELOUR trial. (Hall A; Poster Bd #: 255) - Apr 24, 2024 - Abstract #ASCO2024ASCO_2661;
In this high-risk cohort of pts with rectal cancer, 24.3% of pts had a cCR at time of primary assessment. Background: Second-line treatment with aflibercept and FOLFIRI in patients with metastatic colorectal carcinoma (mCRC) previously treated with oxaliplatin improved overall survival (OS) versus placebo [Hazard ratio (HR), 0.81; 95% CI, 0.71