leucovorin calcium / Generic mfg. 
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  • ||||||||||  varlitinib (ASLAN001) / ASLAN Pharma
    Enrollment closed, Trial completion date, Trial primary completion date, Combination therapy:  ASLAN001 in Combination With Oxaliplatin and Capecitabine or Oxaliplatin and 5-FU With Leucovorin (clinicaltrials.gov) -  Apr 28, 2021   
    P1,  N=60, Active, not recruiting, 
    These data strongly suggest non-inferiority and support equipoise in decision making in modern practice. Recruiting --> Active, not recruiting | Trial completion date: Jun 2020 --> Jun 2021 | Trial primary completion date: Jun 2020 --> Jun 2021
  • ||||||||||  Abraxane (albumin-bound paclitaxel) / BMS, Otsuka
    Clinical, Retrospective data, Journal:  Nab-paclitaxel: An effective third-line chemotherapy in patients with advanced, unresectable gallbladder cancer. (Pubmed Central) -  Apr 28, 2021   
    This retrospective study was conducted to present the treatment outcomes with three lines of chemotherapies in a subset of patients with advanced, unresectable GBC with the primary objective to determine the response rates with nab-paclitaxel as the third-line chemotherapy after failure of the first-line gemcitabine and platinum and the second-line FOLFOX-4 (oxaliplatin, leucovorin and 5-FU) therapy...The dose of gemcitabine and cisplatin or carboplatin was 1 g/m on days 1 and 8 and 75 mg/m (or target AUC of 5) on day 1, in a 21-day cycle...Common Terminology Criteria (CTC) grade 3 or 4 haematological toxicities were observed in 28.6, 38.1 and 23.8 per cent of patients on gemcitabine/platinum, FOLFOX-4 and nab-paclitaxel therapy, respectively. Our study suggests the clinical benefit of nab-paclitaxel chemotherapy in prolonging OS in a selected subgroup of advanced, unresectable GBC patients after failure of the first-line gemcitabine and platinum and the second-line FOLFOX-4 therapy.
  • ||||||||||  napabucasin (BBI608) / Sumitomo Pharma
    Enrollment closed, Enrollment change:  Rollover Study to Provide Continued Access to Napabucasin for Patients Enrolled in Boston Biomedical-sponsored Protocols (clinicaltrials.gov) -  Apr 28, 2021   
    P1,  N=7, Active, not recruiting, 
    Our study suggests the clinical benefit of nab-paclitaxel chemotherapy in prolonging OS in a selected subgroup of advanced, unresectable GBC patients after failure of the first-line gemcitabine and platinum and the second-line FOLFOX-4 therapy. Enrolling by invitation --> Active, not recruiting | N=10 --> 7
  • ||||||||||  Bavencio (avelumab) / EMD Serono, Pfizer
    [VIRTUAL] Efficacy and safety of neoadjuvant short-course radiation followed by mFOLFOX-6 plus avelumab for locally-advanced rectal adenocarcinoma: Averectal study () -  Apr 26, 2021 - Abstract #ESMOGI2021ESMO_GI_116;    
    P2
    Methods This is an investigator-initiated, open-label, single-arm, multicenter, phase II study, adopting Simon s two-stage aiming at evaluating the pCR rate and safety of using short-course radiation therapy (25 Grays in 5 fractions), followed by 6 cycles of mFOLFOX-6 (oxaliplatin, 5-FU and leucovorin) plus avelumab, then total mesorectal excision (TME) 3-4 weeks after last dose in patients with locally-advanced, potentially resectable rectal adenocarcinoma...Conclusions Based on this analysis, the primary endpoint was successfully met with significant improvement in pCR (37.5%, p=0.025) and mpRR rates in the setting of an acceptable safety profile. 3-year disease-free survival and overall survival will be reported later in the final study manuscript.
  • ||||||||||  [VIRTUAL] Effect of prior bevacizumab treatment in BRAF V600E-mutant metastatic colorectal cancer: Overall survival with encorafenib + cetuximab +/- binimetinib in BEACON CRC () -  Apr 26, 2021 - Abstract #ESMOGI2021ESMO_GI_100;    
    P3
    The trial evaluated encorafenib plus cetuximab with or without binimetinib (triplet or doublet, respectively) versus investigators choice of irinotecan or FOLFIRI plus cetuximab (control)...Additional analyses exploring the potential impact of prior bevacizumab use on encorafenib plus cetuximab with or without binimetinib treatment will be presented. Conclusions This exploratory post hoc analysis evaluates OS in patients from BEACON CRC treated with encorafenib plus cetuximab with or without binimetinib to investigate the potential effects of prior bevacizumab treatment on subsequent regimens for patients with BRAF V600E-mutant mCRC.
  • ||||||||||  Avastin (bevacizumab) / Roche, Erbitux (cetuximab) / Eli Lilly, EMD Serono, Zelboraf (vemurafenib) / Roche
    [VIRTUAL] 5-FU/LV + cetuximab + vemurafenib as maintenance therapy for BRAF-mutant (BRAFmut) metastatic colorectal cancer: Efficacy, safety, and exploratory biomarker findings from Cohort 1 of the MODUL trial () -  Apr 26, 2021 - Abstract #ESMOGI2021ESMO_GI_98;    
    P2
    Methods Control treatment was fluoropyrimidine [FP]/bevacizumab (1600 2400 mg/m 2 5-FU 46-h IV infusion d1 q2w; LV 400 mg/m 2 2-h infusion d1 q2w; or 1000 mg/m 2 bid capecitabine orally d1 14 q3w; bevacizumab 5 mg/kg 15 30-min IV infusion d1 q2w)...Exploratory biomarker findings revealed that selective pressure of the treatment arm leads to acquired mutations that reactivate and converge in the MAPK pathway as drivers of resistance to cetuximab + vemurafenib. Further mutation analyses need to be performed to confirm and identify other mechanisms of resistance to cetuximab + vemurafenib in patients with BRAF mut mCRC that might inform future combination strategies.
  • ||||||||||  Keytruda (pembrolizumab) / Merck (MSD), Avastin (bevacizumab) / Roche, Erbitux (cetuximab) / Eli Lilly, EMD Serono
    [VIRTUAL] Final overall survival for the phase 3 KN177 study: Pembrolizumab versus chemotherapy in microsatellite instability-high/mismatch repair deficient metastatic colorectal cancer () -  Apr 26, 2021 - Abstract #ESMOGI2021ESMO_GI_93;    
    P3
    Methods A total of 307 patients with MSI-H/dMMR mCRC and ECOG PS 0 or 1 were randomized 1:1 to 1L pembrolizumab 200 mg Q3W for up to 2y or investigator s choice of mFOLFOX6 or FOLFIRI Q2W bevacizumab or cetuximab...Conclusions As 1L therapy for patients with MSI-H/dMMR mCRC, pembrolizumab vs chemotherapy provides statistically superior PFS with fewer TRAEs, and is associated with a trend toward reduced mortality that did not meet statistical significance likely due to the high crossover rate from chemotherapy to anti-PD1/PD-L1 therapies. Together these data confirm pembrolizumab as a new standard-of-care in the 1L for patients with MSI-H/dMMR mCRC.
  • ||||||||||  Abraxane (albumin-bound paclitaxel) / BMS, Otsuka
    [VIRTUAL] Treatment sequences and prognostic factors in metastatic pancreatic ductal adenocarcinoma: Univariate and multivariate analyses of a real-world study in Europe () -  Apr 26, 2021 - Abstract #ESMOGI2021ESMO_GI_12;    
    The treatment (trt) sequences were as follows: (trt1) gemcitabine + nab-paclitaxel followed by fluoropyrimidine combinations (n=286); (trt2) (m)FOLFIRINOX followed by gemcitabine combinations (n=263); (trt3) (m)FOLFIRINOX followed by gemcitabine monotherapy (n=228); (trt4) gemcitabine + nab-paclitaxel followed by fluoropyrimidine monotherapy (n=65); (trt5) gemcitabine monotherapy followed by fluoropyrimidine monotherapy (n=41); (trt6) gemcitabine monotherapy followed by fluoropyrimidine combinations (n=32)...Treatment sequences were in accordance with the ESMO guidelines at the time of the study. Liver metastases, treatment sequences, PS, CA19-9, lung metastases and sex were significant independent prognostic factors of OS in this study.
  • ||||||||||  5-fluorouracil / Generic mfg., oxaliplatin / Generic mfg., leucovorin calcium / Generic mfg.
    Clinical, Journal:  FOLFOX treatment response prediction in metastatic or recurrent colorectal cancer patients via machine learning algorithms. (Pubmed Central) -  Apr 24, 2021   
    Early identification of metastatic or recurrent colorectal cancer (CRC) patients who will be sensitive to FOLFOX (5-FU, leucovorin and oxaliplatin) therapy is very important...Candidate models with the best tuning parameters were applied to the test set and the final model showed satisfactory performance. In addition, we also reported that MLKL and CCDC124 gene expression were independent prognostic factors for metastatic CRC patients undergoing FOLFOX therapy.
  • ||||||||||  oxaliplatin / Generic mfg.
    Trial primary completion date:  Lidocaine for Oxaliplatin-induced Neuropathy (clinicaltrials.gov) -  Apr 22, 2021   
    P1/2,  N=38, Active, not recruiting, 
    Trial primary completion date: Nov 2020 --> Nov 2021 Trial primary completion date: Dec 2020 --> Sep 2020
  • ||||||||||  Keytruda (pembrolizumab) / Merck (MSD)
    Trial completion date, Trial primary completion date, IO biomarker:  Perioperative mFOLFOX Plus Pembrolizumab in Gastroesophageal Junction (GEJ) and Stomach Adenocarcinoma (clinicaltrials.gov) -  Apr 22, 2021   
    P2,  N=40, Recruiting, 
    Trial completion date: Jun 2022 --> Sep 2022 | Trial primary completion date: Mar 2021 --> Mar 2022 Trial completion date: Apr 2021 --> Apr 2023 | Trial primary completion date: Apr 2020 --> Apr 2022