- |||||||||| Lonsurf (trifluridine/tipiracil) / Otsuka, Cyramza (ramucirumab) / Eli Lilly
Trial completion date, Trial primary completion date: TAS 102 in Combination With Ramucirumab in Advanced, Refractory Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma (clinicaltrials.gov) - Jan 25, 2021 P2, N=25, Recruiting, This study provides clear evidence to evaluate the effectiveness and safety of trifluridine/tipiracil for patients with highly pretreated metastatic gastric cancer, and the findings will also be published in a peer-reviewed journal. Trial completion date: Jan 2023 --> Jan 2024 | Trial primary completion date: Jan 2021 --> Jan 2022
- |||||||||| Opdivo (nivolumab) / Ono Pharma, BMS
Journal, PD(L)-1 Biomarker, IO biomarker: Questionnaire Survey of Third-Line Chemotherapy for Gastric Cancer in Yamaguchi Prefecture (Pubmed Central) - Jan 22, 2021 Nivolumab was used as the first-choice in more than 80% of the regimens for gastric cancer third-line chemotherapy in Yamaguchi prefecture. There was a difference in consciousness among doctors regarding the timing of switching from second- line to third-line chemotherapy and the timing of switching from nivolumab to fourth-line therapy.
- |||||||||| Lonsurf (trifluridine/tipiracil) / Servier, Otsuka
Journal: Long-Term Survivor with Recurrent Gastric Cancer Using Trifluridine/Tipiracil as a Late-Line Chemotherapy (Pubmed Central) - Jan 22, 2021 Here, we successfully treated 38 months survival case after recurrences following radical gastrectomy for advanced adenocarcinoma of esophago-gastric junction using historical recommended chemotherapy regimens and trifluridine/tipiracil as a fifth-line chemotherapy. Trifluridine/tipiracil therapy contributed to effective and safety treatment even in late-line chemotherapy for recurrent gastric cancer.
- |||||||||| Opdivo (nivolumab) / Ono Pharma, BMS
Retrospective data, Journal, Adverse events: Effect on Prognosis of Immune-Related Adverse Events after Nivolumab Treatment in Gastric Cancer (Pubmed Central) - Jan 22, 2021 Trifluridine/tipiracil therapy contributed to effective and safety treatment even in late-line chemotherapy for recurrent gastric cancer. Long-term efficacy is expected with nivolumab, but it may be necessary to recognize that the onset of serious irAEs might make subsequent treatment difficult.
- |||||||||| Lonsurf (trifluridine/tipiracil) / Otsuka, Ibrance (palbociclib) / Pfizer, Mektovi (binimetinib) / Ono Pharma, Pierre Fabre, Pfizer
Trial completion date, Trial primary completion date, Metastases: ACCRU-GI-1618: Binimetinib and Palbociclib or TAS-102 in Treating Patients With KRAS and NRAS Mutant Metastatic or Unresectable Colorectal Cancer (clinicaltrials.gov) - Jan 22, 2021 P2, N=112, Recruiting, In conclusion, the TAS-102 plus Bev therapy may be a useful option for the late-line treatment of unresectable advanced recurrent colorectal cancer. Trial completion date: Dec 2022 --> Dec 2025 | Trial primary completion date: Dec 2020 --> Dec 2022
- |||||||||| Onivyde (nanoliposomal irinotecan) / Servier, Ipsen, Takeda
Trial primary completion date, Combination therapy: Nanoliposomal Irinotecan (Nal-IRI, ONIVYDE (clinicaltrials.gov) - Jan 5, 2021 P1, N=57, Recruiting, TT-B treatment showed promising clinical activity in untreated patients with unresectable mCRC ineligible for intensive therapy, with an acceptable safety profile and no clinically relevant changes in QoL. Trial primary completion date: Dec 2020 --> Mar 2021
- |||||||||| Lonsurf (trifluridine/tipiracil) / Otsuka, Mekinist (trametinib) / Novartis, BeiGene
Trial completion date, Trial primary completion date, Combination therapy, Surgery, Metastases: Trametinib and Trifluridine and Tipiracil Hydrochloride in Treating Patients With Colon or Rectal Cancer That is Advanced, Metastatic, or Cannot Be Removed by Surgery (clinicaltrials.gov) - Dec 17, 2020 P1, N=26, Active, not recruiting, Findings could help inform decision making regarding the choice and sequencing of treatment with FTD + TPI versus REG in patients with mCRC. Trial completion date: Sep 2020 --> Sep 2021 | Trial primary completion date: Sep 2020 --> Sep 2021
- |||||||||| Lonsurf (trifluridine/tipiracil) / Otsuka
Trial completion date, Trial primary completion date, Metastases: A Phase I Study of TAS-102 in Patients With Advanced Solid Tumors With Renal Impairment (clinicaltrials.gov) - Dec 16, 2020 P1, N=48, Active, not recruiting, Trial completion date: Dec 2021 --> Dec 2022 | Trial primary completion date: Dec 2020 --> Dec 2021 Trial completion date: Jun 2020 --> Jun 2021 | Trial primary completion date: Jun 2020 --> Jun 2021
- |||||||||| Lonsurf (trifluridine/tipiracil) / Servier, Otsuka, TAS / 102
Journal: TAS-102 has a tumoricidal activity in multiple myeloma. (Pubmed Central) - Dec 10, 2020 TAS-102 has shown its efficacies in the drug-resistant myeloma cells, and the combination of TAS-102 and bortezomib has a synergistic anti-myeloma activity. Our preclinical studies indicate that TAS-102 is a potential novel agent for myeloma therapy.
- |||||||||| Elunate (fruquintinib) - Chi / Med
[VIRTUAL] FRESCO-2: A global phase III study of the efficacy and safety of fruquintinib in patients (pts) with metastatic colorectal cancer (mCRC). () - Dec 9, 2020 - Abstract #ASCOGI2021ASCO_GI_405; P3 Current standard of care (SOC) after pts progress on trifluridine/tipiracil (TAS-102) or regorafenib is re-challenge with previous systemic treatments, enrollment in a clinical trial, or best supportive care (BSC)...Fruquintinib is approved in China to treat pts with mCRC who received or are intolerant to fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, anti-VEGF therapy, and, if RAS wild type, anti-epidermal growth factor receptor (EGFR) therapy...If enrichment of post-regorafenib pts occurs, enrollment to that strata will be capped at approximately 262. FRESCO-2 will be activated in the US, EU, and Japan; global enrollment is anticipated over 13 mo.
- |||||||||| Erbitux (cetuximab) / Eli Lilly, EMD Serono, Vectibix (panitumumab) / Amgen, Takeda
[VIRTUAL] PULSE: A randomized phase II open label study of panitumumab rechallenge versus standard therapy after progression on anti-EGFR therapy in patients with RAS wild-type metastatic colorectal cancer (mCRC). () - Dec 9, 2020 - Abstract #ASCOGI2021ASCO_GI_394; P=N/A, P2 This is a randomized phase II, open label study designed to compare the overall survival (OS) of panitumumab rechallenge versus SOC (investigator choice TAS-102 or regorafenib)...Eligible patients have radiographically measurable KRAS, NRAS, and BRAF codon 600 wild-type mCRC based on tumor tissue testing, and must have experienced progression or intolerance to treatment with a fluoropyrimidine, oxaliplatin, irinotecan, an anti-VEGF Ab, and an anti-PD-1 Ab if the tumor has mismatch repair deficiency or is MSI-H...This study began enrollment in 6/2020. Recruitment is ongoing at 16 sites in the Academic and Community Cancer Research United (ACCRU) network (ACCRU-GI-1623).
- |||||||||| Lonsurf (trifluridine/tipiracil) / Servier, Otsuka, Stivarga (regorafenib) / Bayer
[VIRTUAL] Continuing education curriculums and outcomes on progressive metastatic colorectal cancer treatment. () - Dec 9, 2020 - Abstract #ASCOGI2021ASCO_GI_122; This series of online, expert-led, CME-certified educational activities resulted in significant improvement in knowledge, competence, confidence, and performance among learners regarding the management of patients with progressive metastatic colorectal cancer over time. These results demonstrate the effectiveness of on-demand education as new data emerge and indications expand to reinforce existing knowledge, close persistent gaps, and increase confidence in managing these patients.
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