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424 Diseases |  |
808 Trials |
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808 Trials |  |
14431 News |  |
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- | Rubraca (rucaparib) / Pharma& Schweiz, Onivyde (nanoliposomal irinotecan) / Servier, Ipsen
Trial completion date, Trial primary completion date, Metastases: Liposomal Irinotecan, Fluorouracil, Leucovorin Calcium, and Rucaparib in Treating Patients With Metastatic Pancreatic, Colorectal, Gastroesophageal, or Biliary Cancer (clinicaltrials.gov) - May 10, 2021
P2, N=110, Recruiting, Sponsor: Academic and Community Cancer Research United
Trial completion date: Jul 2022 --> Jul 2026 | Trial primary completion date: Aug 2021 --> Nov 2024
- || oxaliplatin / Generic mfg., leucovorin calcium / Generic mfg.
Clinical, Journal: Efficacy and toxicity of adjuvant chemotherapy on colorectal cancer patients: how much influence from the genetics? (Pubmed Central) - May 8, 2021
Furthermore, we report a significant association of the TS 3'UTR 6 bp/6 bp polymorphism and the XRCC1 rs25487 with a higher risk of developing anaemia and diarrhoea, respectively. On the other hand, none of the studied polymorphisms showed clinically relevant association with disease-free survival and overall survival or early failure to adjuvant FOLFOX therapy.
- || Folotyn (pralatrexate) / Aurobindo
Clinical, Journal: Pralatrexate injection for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma. (Pubmed Central) - May 7, 2021
Pharmacokinetics and mechanism of action of pralatrexate are discussed as well as its clinical efficacy and safety in comparison to other agents available in R/R PTCL.Expert opinion: Pralatrexate is an active agent in relapsed/refractory PTCL with lower response rates seen in patients with angioimmunoblastic T cell lymphomas. Mucositis is the most frequently observed adverse event and this can be mitigated by the use of leucovorin along with cyanocobalamin and folic acid.
- || cisplatin / Generic mfg.
Review, Journal: Biliary cancer: gateway to comprehensive molecular profiling. (Pubmed Central) - May 7, 2021
Median PFS and OS were 9 and 14 months, respectively. Patients should be encouraged to participate in clinical trials.
- | Bavencio (avelumab) / EMD Serono
Enrollment closed, Trial completion date, Trial primary completion date, Tumor mutational burden: SAMCO: Standard Chemotherapy vs Immunotherapie in 2nd Line Treatment of MSI Colorectal Mestastatic Cancer (clinicaltrials.gov) - May 7, 2021
P2, N=132, Active, not recruiting, Sponsor: Federation Francophone de Cancerologie Digestive
Patients should be encouraged to participate in clinical trials. Recruiting --> Active, not recruiting | Trial completion date: Mar 2025 --> May 2023 | Trial primary completion date: Feb 2024 --> May 2022
- ||| budigalimab (ABBV-181) / AbbVie, giloralimab (ABBV-927) / AbbVie
Enrollment open, Adverse events, Combination therapy, Metastases: Study to Evaluate Adverse Events and Change in Disease Activity When Intravenous (IV) Infusion of ABBV-927 is Administered in Combination With IV Modified FOLFIRINOX (mFFX) With or Without IV Budigalimab Compared to mFFX in Adult Participants With Untreated Pancreatic Cancer Metastasis (clinicaltrials.gov) - May 6, 2021
P1b/2, N=129, Recruiting, Sponsor: AbbVie
Recruiting --> Active, not recruiting | Trial completion date: Mar 2025 --> May 2023 | Trial primary completion date: Feb 2024 --> May 2022 Not yet recruiting --> Recruiting
- || dilpacimab (ABT-165) / AbbVie
Trial completion date, Trial primary completion date, Metastases: A Study of ABT-165 in Subjects With Solid Tumors (clinicaltrials.gov) - May 6, 2021
P1, N=101, Active, not recruiting, Sponsor: AbbVie
Not yet recruiting --> Recruiting Trial completion date: Mar 2021 --> Oct 2023 | Trial primary completion date: Mar 2021 --> Oct 2023
- ||| dalutrafusp alfa (AGEN1423) / Agenus
Trial completion date, Trial termination, Combination therapy, Monotherapy, Metastases: Study of Dalutrafusp Alfa (Formerly GS-1423) in Participants With Advanced Solid Tumors (clinicaltrials.gov) - May 6, 2021
P1a/1b, N=22, Terminated, Sponsor: Gilead Sciences
Trial completion date: Oct 2021 --> Apr 2021 | Active, not recruiting --> Terminated; The decision to discontinue the study was made based on the totality of the clinical, pharmacokinetic, and pharmacodynamic findings. No safety concerns were observed.
- || irinotecan / Generic mfg.
Clinical, Journal: The Sequential Radiographic Effects of Preoperative Chemotherapy and (Chemo)Radiation on Tumor Anatomy in Patients with Localized Pancreatic Cancer. (Pubmed Central) - May 5, 2021
Less than one-third of patients treated with FOLFIRINOX or GA with or without (chemo)radiation experienced either RECIST partial response or radiographic downstaging prior to surgery. The incidence of tumor downstaging was higher and the magnitude of tumor volume loss was greater following chemotherapy than after (chemo)radiation.
- || onvansertib (PCM-075) / Cardiff Oncology
Enrollment open, Combination therapy, Metastases: Onvansertib in Combination With Nanoliposomal Irinotecan, Leucovorin, and Fluorouracil for Second-Line Treatment of Participants With Metastatic Pancreatic Ductal Adenocarcinoma (clinicaltrials.gov) - May 4, 2021
P2, N=40, Recruiting, Sponsor: Cardiff Oncology
The incidence of tumor downstaging was higher and the magnitude of tumor volume loss was greater following chemotherapy than after (chemo)radiation. Not yet recruiting --> Recruiting
- || 5-fluorouracil / Generic mfg., leucovorin calcium / Generic mfg.
https://t.co/wDLX2f7i01 I know that this is ancient paper but it did show statistically significant improvement in PFS when you give leucovorin with 24h Inf 5FU C/w 24h inf 5FU alone (Twitter) - May 4, 2021
- || leucovorin calcium / Generic mfg.
Sin Leucovorina por favor ! (Twitter) - May 3, 2021
- || leucovorin calcium / Generic mfg.
I have been confused here and was skipping LV when skipping bolus ,but if I am not wrong in modified folfirinox they left leucovorin in. (Twitter) - May 3, 2021
- ||| 5-fluorouracil / Generic mfg., leucovorin calcium / Generic mfg.
No 5-FU bolus➡️❌Leucovorin. #CRCSM #PANCSM #STCSM #ESOCSM (Twitter) - May 3, 2021
- || Onivyde (nanoliposomal irinotecan) / Servier, Ipsen
Trial completion date, Trial primary completion date: NALIRICC: Nal-IRI and 5-FU Compared to 5-FU in Patients With Cholangio- and Gallbladder Carcinoma Previously Treated With Gemcitabine-based Therapies (clinicaltrials.gov) - May 3, 2021
P2, N=100, Recruiting, Sponsor: AIO-Studien-gGmbH
Not yet recruiting --> Recruiting Trial completion date: Jul 2021 --> Jan 2022 | Trial primary completion date: Jan 2021 --> Sep 2021
- || Onivyde (nanoliposomal irinotecan) / Servier, Ipsen
Enrollment closed, Trial completion date, Trial primary completion date, Metastases: AIO-NIFE-trial: Nal-IRI With 5-fluorouracil (5-FU) and Leucovorin or Gemcitabine Plus Cisplatin in Advanced Biliary-tract Cancer (clinicaltrials.gov) - May 3, 2021
P2, N=93, Active, not recruiting, Sponsor: AIO-Studien-gGmbH
Trial completion date: Jul 2021 --> Jan 2022 | Trial primary completion date: Jan 2021 --> Sep 2021 Recruiting --> Active, not recruiting | Trial completion date: Jul 2023 --> Jul 2022 | Trial primary completion date: Dec 2019 --> Sep 2020
- || bemarituzumab (AMG 552) / Amgen
Trial completion date, Trial primary completion date, Metastases: FIGHT: A Study of Bemarituzumab (FPA144) Combined With Modified FOLFOX6 (mFOLFOX6) in Gastric/Gastroesophageal Junction Cancer (clinicaltrials.gov) - May 3, 2021
P2, N=155, Active, not recruiting, Sponsor: Five Prime Therapeutics, Inc.
Recruiting --> Active, not recruiting | Trial completion date: Jul 2023 --> Jul 2022 | Trial primary completion date: Dec 2019 --> Sep 2020 Trial completion date: Dec 2021 --> May 2022 | Trial primary completion date: Mar 2021 --> Sep 2020
- || leucovorin calcium / Generic mfg.
This is an important and relevant question. I do not see any reason why leucovorin can not be given over 30 minutes, saving some chair time. (Twitter) - May 1, 2021
- || methotrexate / Generic mfg.
Clinical, Journal: Life-threatening complications after high-dose methotrexate and the benefits of glucarpidase as salvage therapy: a cohort study of 468 patients. (Pubmed Central) - May 1, 2021
Notwithstanding potentially confounding factors, most patients with AKI who received glucarpidase (n = 41) developed extra-renal toxicity (leading to the death of two patients) despite early administration. Thus, severe toxicity and death can occur whether or not glucarpidase is administered, which confirms the need for further interventional studies to provide greater precision on its role in the management of HD-MTX toxicity.
- || irinotecan / Generic mfg.
Clinical, Journal: IL15RA and SMAD3 Genetic Variants Predict Overall Survival in Metastatic Colorectal Cancer Patients Treated with FOLFIRI Therapy: A New Paradigm. (Pubmed Central) - May 1, 2021
A new paradigm in cancer chemotherapy derives from the interaction between chemotherapeutics, including irinotecan and 5-fluorouracil (5-FU), and the immune system...This study aims to identify genetic determinants in the immuno-related pathways predictive of overall survival (OS) after FOLFIRI (irinotecan, 5-FU, leucovorin) therapy...The calculated genetic score successfully discriminated patients with different survival probabilities (p < 0.0001 log-rank test). These findings provide new insight on the prognostic value of genetic determinants, such as IL15RA and SMAD3 markers, and could offer a new decision tool to improve the clinical management of patients with mCRC receiving FOLFIRI.
- | Erbitux (cetuximab) / Eli Lilly
Trial completion: Efficacy and Safety of the Prophylactic Use of Doxycycline +/- Vitamin K Cream (clinicaltrials.gov) - Apr 30, 2021
P2, N=124, Completed, Sponsor: Universit
These findings provide new insight on the prognostic value of genetic determinants, such as IL15RA and SMAD3 markers, and could offer a new decision tool to improve the clinical management of patients with mCRC receiving FOLFIRI. Recruiting --> Completed
- | Erbitux (cetuximab) / Eli Lilly
Biomarker, Trial completion date, Trial primary completion date, Monotherapy, Metastases: Cetuximab Maintenance Treatment Versus Continuation After Induction Therapy in mCRC (clinicaltrials.gov) - Apr 30, 2021
P2/3, N=200, Not yet recruiting, Sponsor: Ruijin Hospital
Recruiting --> Completed Trial completion date: Oct 2021 --> Oct 2022 | Trial primary completion date: Oct 2021 --> Oct 2022
- [VIRTUAL] Cost-effectiveness of adjuvant chemotherapy for stage III colon cancer in the South African public healthcare setting. () - Apr 29, 2021 - Abstract #ASCO2021ASCO_4969;
FOLFOX for 6 months, with a greater effectiveness, may be cost-effective if the administration cost decreases significantly . The optimal strategy in other settings may vary according to the local WTP threshold.
- irinotecan / Generic mfg.
[VIRTUAL] Neoadjuvant chemotherapy and disease recurrence after curative-intent surgery in patients with pancreatic adenocarcinoma: A single-center retrospective review. () - Apr 29, 2021 - Abstract #ASCO2021ASCO_4764;
56%; p = 0.46) . No predictive associations were identified in patients with disease recurrence .
- Odomzo (sonidegib) / Sun Pharma, Abraxane (albumin-bound paclitaxel) / BMS, Otsuka
[VIRTUAL] Phase I/II study of LDE225 in combination with gemcitabine and nab-paclitaxel in patients with metastatic pancreatic cancer. () - Apr 29, 2021 - Abstract #ASCO2021ASCO_4390;
P1/2
This study shows that LDE225 in combination with gemcitabine and nab-paclitaxel is well-tolerated in patients with metastatic PDAC and has promising efficacy after prior treatment with FOLFIRINOX . Functional MRI suggested that LDE225 causes increased tumor diffusion and works particularly well in patients with poor baseline perfusion.
- irinotecan / Generic mfg.
[VIRTUAL] Real-world neo-adjuvant with or without adjuvant treatment patterns among pancreatic ductal adenocarcinoma patients in the U.S. () - Apr 29, 2021 - Abstract #ASCO2021ASCO_4372;
The majority (70%) of patients that underwent PDAC resection surgery did not receive neo-adjuvant treatment and about a third of patients did not receive any adjuvant treatment . These results suggest an unmet need in the management of PDAC.
- oxaliplatin / Generic mfg., leucovorin calcium / Generic mfg.
[VIRTUAL] Analysis of DNA damage repair pathway genes as a predictive biomarker for HAIC in hepatocellular carcinoma. () - Apr 29, 2021 - Abstract #ASCO2021ASCO_4316;
The DDR pathways was associated with higher TMB level . Preliminary data from clinical cohorts suggested better treatment outcomes of HAIC with FOLFOX in DDR mutation HCC patients.
- Avastin (bevacizumab) / Roche, Erbitux (cetuximab) / Eli Lilly, EMD Serono
[VIRTUAL] Blood tests to predict one- to two-year survival of patients with difficult cancers. () - Apr 29, 2021 - Abstract #ASCO2021ASCO_4315;
P2
Ts warrant development: validation with GFLIO and other therapy and other cancers; to improve Ts, models for eligibility and geriatric criteria; to identify false -/+ trials; and personalize trials to correct UnF Ts . FTs, with GFLIO, can change prognosis and practice for > 50% of pts now advised “against” any therapy due to a clinical estimate of “less than 6 -10 mos to live.”
- oxaliplatin / Generic mfg., leucovorin calcium / Generic mfg.
[VIRTUAL] A prognostic model to predict survival after hepatic arterial infusion chemotherapy for hepatocellular carcinoma with portal vein invasion. () - Apr 29, 2021 - Abstract #ASCO2021ASCO_4314;
FTs, with GFLIO, can change prognosis and practice for > 50% of pts now advised “against” any therapy due to a clinical estimate of “less than 6 -10 mos to live.” The NCV-score identifies advanced HCC patients who obtain satisfying survival benefit for HAIC of oxaliplatin plus fluorouracil/leucovorin and provides individual survival predicting.
- zolbetuximab (IMAB362) / Astellas
[VIRTUAL] Effect of ethnicity and chemotherapy (mFOLFOX6) on zolbetuximab pharmacokinetics in patients with claudin 18.2-positive locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma (G/GEJ). () - Apr 29, 2021 - Abstract #ASCO2021ASCO_4244;
P1, P2
The analyses suggest no apparent ethnic differences in zolbetuximab PK across Japanese/Asian and Western pts and no PK interactions between zolbetuximab and mFOLFOX6 . These results support the use of zolbetuximab and mFOLFOX without the need for dose adjustment in global phase 3 trials.
- zolbetuximab (IMAB362) / Astellas
[VIRTUAL] Phase 2 study of zolbetuximab plus mFOLFOX6 in claudin 18.2-positive locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma (G/GEJ): ILUSTRO cohort 2. () - Apr 29, 2021 - Abstract #ASCO2021ASCO_4230;
P2
Results suggest promising antitumor activity with zolbetuximab+mFOLFOX6 in metastatic or locally advanced G/GEJ . The safety profile was manageable and no new safety signals were identified.
- AiRuiKa (camrelizumab) / Incyte
[VIRTUAL] Efficacy and safety of camrelizumab combined with FLOT versus FLOT alone as neoadjuvant therapy in patients with resectable locally advanced gastric and gastroesophageal junction adenocarcinoma who received D2 radical gastrectomy. () - Apr 29, 2021 - Abstract #ASCO2021ASCO_4195;
Eligible patients diagnosed as resectable locally advanced GC/GEJC were randomized to receive neoadjuvant treatment, in arm A, the patients received FLOT alone (docetaxel 50 mg/m²; oxaliplatin 85 mg/m²; leucovorin 200 mg/m²; 5-FU 2600 mg/m², every 2 weeks), in arm B, the patients received FLOT combined with camrelizumab(camrelizumab 200mg intravenously every 3 weeks)... Camrelizumab combined with FLOT showed promising efficacy as neoadjuvant treatment for patients with locally advanced gastric or GEJ adenocarcinoma, with low complications and acceptable toxicity.
- Avastin (bevacizumab) / Roche
[VIRTUAL] Phase I dose-escalation study of desynchronized irinotecan plus bevacizumab, oxaliplatin, 5-fluorouracil, and folinic acid (bFOLFIRINOX-3) administration in chemorefractory metastatic colorectal cancer patients. () - Apr 29, 2021 - Abstract #ASCO2021ASCO_4137;
P1/2
was well tolerated and feseably . The regimen resulted in high response rate in chemorefractory metastatic colorectal cancer .
- 5-fluorouracil / Generic mfg., leucovorin calcium / Generic mfg.
[VIRTUAL] Nano-Folfox for cancer therapy (Channel 06) - Apr 29, 2021 - Abstract #AACR2021AACR_5891;
Combination of Folinic acid, 5-FU and Oxaliplatin (FOLFOX) is a standard chemotherapy for both colorectal and liver cancers...Mice bearing orthotopic colorectal or liver cancer were treated by IV injection of either nanoparticles alone or in combination. Two nanoformulations combined induced reactive oxygen species and immunogenetic cell death for synergistic chemoimmunotherapy, resulting in eradication of both colorectal cancer and hepatocellular carcinoma in mouse models.
- irinotecan / Generic mfg.
[VIRTUAL] Use of the silicasome platform for pancreatic cancer chemo-immunotherapy (Channel 06) - Apr 29, 2021 - Abstract #AACR2021AACR_5890;
As for irinotecan, the response could be enhanced by co-treatment with anti-PD1. In summary, we demonstrate effective strategies for using ICD-inducing chemotherapy in the silicasome platform, allowing us to significantly augment the chemotherapy response to two FOLFIRINOX drugs by additional immunotherapy.
- | Erbitux (cetuximab) / Eli Lilly, EMD Serono
Journal: Radiomics Response Signature for Identification of Metastatic Colorectal Cancer Sensitive to Therapies Targeting EGFR Pathway. (Pubmed Central) - Apr 29, 2021
Radiomics response signature can serve as an intermediate surrogate marker of overall survival. The signature outperformed known biomarkers in providing an early prediction of treatment-sensitivity and could be used to guide cetuximab treatment continuation decisions.
- | methotrexate / Generic mfg.
Observational data, Retrospective data, Journal: The management of hydatidiform mole using prophylactic chemotherapy and hysterectomy for high-risk patients decreased the incidence of gestational trophoblastic neoplasia in Vietnam: a retrospective observational study. (Pubmed Central) - Apr 29, 2021
The results of this study suggest that prophylactic chemotherapy and hysterectomy may be useful for high-risk HM patients to reduce post-molar GTN in settings in which the risk of post-molar GTN and loss to follow-up after HM are greater and hCG measurements and appropriate GTN treatments are unavailable. However, future studies on the long-term outcomes and side effects of prophylactic therapies on HM are required.
- | Trial primary completion date: Total Therapy for Infants With Acute Lymphoblastic Leukemia (ALL) I (clinicaltrials.gov) - Apr 29, 2021
P1/2, N=50, Recruiting, Sponsor: St. Jude Children's Research Hospital
However, future studies on the long-term outcomes and side effects of prophylactic therapies on HM are required. Trial primary completion date: Jul 2021 --> Oct 2022
- ||| Zaltrap (ziv-aflibercept IV) / Sanofi
Enrollment closed, Enrollment change: mFOLFOX6 vs. mFOLFOX6 + Aflibercept as Neoadjuvant Treatment in MRI-defined T3-rectal Cancer (clinicaltrials.gov) - Apr 29, 2021
P2, N=119, Active, not recruiting, Sponsor: AIO-Studien-gGmbH
Trial primary completion date: Jul 2021 --> Oct 2022 Recruiting --> Active, not recruiting | N=209 --> 119
- Onivyde (nanoliposomal irinotecan) / Servier, Ipsen, Takeda
[VIRTUAL] A phase 2 study of liposomal irinotecan with 5-fluorouracil and leucovorin in squamous cell carcinoma of head and neck or esophagus after prior platinum-based chemotherapy or chemoradiotherapy. () - Apr 28, 2021 - Abstract #ASCO2021ASCO_2480;
P2
Clinical benefits including complete tumor response were noted in H&N patients . The role of this regimen in selective patients and the efficacy of combination with immunotherapeutic agents warrant further explorations.
- Vectibix (panitumumab) / Amgen, Takeda
[VIRTUAL] FOLFOX plus panitumumab or FOLFOX alone as additive therapy following R0/1 resection of RAS wild-type colorectal cancer liver metastases: The PARLIM trial (AIO KRK 0314). () - Apr 28, 2021 - Abstract #ASCO2021ASCO_2381;
P2
The PARLIM trial clearly failed to demonstrate a PFS rate of 65% after resection of colorectal liver metastases 2 years after randomisation, potentially indicating that the generally high frequency of recurrence and the choice of primary endpoint did not correspond in this study population . However, a trend for improved PFS and OS by the addition of panitumumab to 12 wks of FOLFOX followed by 12 wks panitumumab maintenance therapy may support future trials with ant-EGFR antibodies in this specific treatment setting.
- Avastin (bevacizumab) / Roche
[VIRTUAL] Examination of the tumor immune microenvironment (TIME) with multispectral immunofluorescence (m-IF): Association of markers with prognosis and bevacizumab (bev) benefit in NRG Oncology/NSABP C-08. () - Apr 28, 2021 - Abstract #ASCO2021ASCO_2342;
All T cells and PD-1, PD-L1, and LAG3 cells, were associated with better prognosis in the entire cohort but when pts were stratified for MMR status differences in their association with prognosis and bev benefit emerged . PD-1, CD8, and CD8/PD-1 cells were associated with bev harm in pMMR but bev benefit in dMMR .
- Vectibix (panitumumab) / Amgen, Takeda
[VIRTUAL] Maintenance therapy with 5-fluoruracil/leucovorin (5FU/LV) plus panitumumab (pmab) or 5FU/LV alone in RAS wildtype (WT) metastatic colorectal cancer (mCRC) - the PANAMA trial (AIO KRK 0212). () - Apr 28, 2021 - Abstract #ASCO2021ASCO_2323;
P2
Clinical Trial Registry Number: NCT01991873 Funding: AMGEN, Arbeitsgemeinschaft Internistische Onkologie (AIO) Background: Planned discontinuation or stop-and-go use of oxaliplatin are established strategies in the systemic therapy of mCRC... In RAS WT mCRC, maintenance therapy with 5FU/LV+ pmab appears to be superior to 5FU/LV alone and should be regarded as standard of care maintenance regimen following induction therapy with FOLFOX plus pmab.
- Avastin (bevacizumab) / Roche, Erbitux (cetuximab) / Eli Lilly, EMD Serono
[VIRTUAL] Randomized study to investigate FOLFOXIRI plus either bevacizumab or cetuximab as first-line treatment of BRAF V600E-mutant mCRC: The phase-II FIRE-4.5 study (AIO KRK-0116). () - Apr 28, 2021 - Abstract #ASCO2021ASCO_2320;
P2
FIRE-4.5 is the first prospective and randomized study investigating efficacy of FOLFOXIRI combined with targeted therapy in the first-line treatment of BRAF V600E-mutant mCRC . FOLFOXIRI plus either bevacizumab or cetuximab have comparable efficacy with differential effects according to primary tumor sidedness supporting the heterogeneity of BRAF V600E-mutant subpopulation of mCRC.
- irinotecan / Generic mfg., gemcitabine / Generic mfg.
[VIRTUAL] Total neoadjuvant FOLFIRINOX or gemcitabine-based chemoradiotherapy and adjuvant gemcitabine for resectable and borderline resectable pancreatic cancer (PREOPANC-2): A nationwide multicenter randomized controlled trial. () - Apr 28, 2021 - Abstract #ASCO2021ASCO_1583;
Between June 2018 and January 2021, 375 patients were enrolled in 20 centers in the Netherlands and accrual is complete . Final analyses are expected at the end of 2022.
- Onivyde (nanoliposomal irinotecan) / Servier, Ipsen, Takeda
[VIRTUAL] A phase II, open-label pilot study evaluating the safety and activity of liposomal irinotecan (Nal-IRI) in combination with 5-FU and oxaliplatin (NALIRIFOX) in preoperative treatment of pancreatic adenocarcinoma (NEO-Nal-IRI study) (NCT03483038). () - Apr 28, 2021 - Abstract #ASCO2021ASCO_1582;
P2
NCT03483038 . NALIRIFOX regimen components given intravenously (IV) every 14 days.
- Herceptin (trastuzumab) / Roche
[VIRTUAL] A phase II trial of trastuzumab plus modified-FOLFOX for gemcitabine/cisplatin refractory HER2-positive biliary tract cancer (BTC): Multi-institutional study of the Korean Cancer Study Group (KCSG-HB19-14). () - Apr 28, 2021 - Abstract #ASCO2021ASCO_1573;
P2
Patients receive trastuzumab-pkrb 4mg/kg (after 6mg/kg load) D1, oxaliplatin 85mg/m2 D1, leucovorin 200mg/m2 D1, 5-FU 400mg/m2 bolus D1, and 5-FU 2400mg/m2 infusion D1-2 every 2 weeks until unacceptable toxicities or disease progression...As of February 2021, 16 patients have been enrolled . The pre-specified activity goal for the first stage of accrual was met; second stage accrual began in February 2021.
- Bavencio (avelumab) / EMD Serono, Pfizer
[VIRTUAL] MONEO: A phase II study of avelumab (Av) plus FLOT in the peri-operative treatment for patients (pts) with resectable gastric or gastroesophageal junction cancer (GC). () - Apr 28, 2021 - Abstract #ASCO2021ASCO_1567;
P2
At a data cut-off day of 5th of February 2021, 38 patients have been enrolled, 27 of them have had the surgery . Although the difficulties during the COVID19 pandemia, only two patients had been withdrawn from the study.
- Imfinzi (durvalumab) / AstraZeneca
[VIRTUAL] MATTERHORN: Efficacy and safety of neoadjuvant-adjuvant durvalumab and FLOT chemotherapy in resectable gastric and gastroesophageal junction cancer—A randomized, double-blind, placebo-controlled, phase 3 study. () - Apr 28, 2021 - Abstract #ASCO2021ASCO_1563;
P3
Safety and tolerability will be evaluated by adverse events, vital signs, laboratory parameters, and electrocardiogram . Enrollment is ongoing.
- cisplatin / Generic mfg., docetaxel / Generic mfg.
[VIRTUAL] Preventive HIPEC in combination with perioperative FLOT versus FLOT alone for resectable diffuse type gastric and gastroesophageal junction type II/III adenocarcinoma: The phase III “PREVENT” trial of the AIO /CAOGI /ACO. () - Apr 28, 2021 - Abstract #ASCO2021ASCO_1561;
P3
Pts will be randomized 1:1 to receive surgery only and postoperative FLOT (Arm A- Control arm) or surgery + intraoperative HIPEC (cisplatin 75mg/m2 solution administered at a temperature of 42°C for 90 minutes) and postoperative FLOT (Arm B- experimental arm)...First patient was randomized on 18JAN2021 . Currently one patient is recruited.