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TAS-102 Combined With Bevacizumab and Tislelizumab Third-line or Above in the Treatment of Liver Metastasis in Colorectal Cancer

ABSTRACT: To evaluate the clinical efficacy and safety of TAS-102 combined with bevacizumab and tislelizumab in third-line or above treatment in patients with advanced colorectal adenocarcinoma with liver metastasis.

DISEASE(S): Immunotherapy,Colorectal Cancer,Colorectal Neoplasms

PROVIDER: 2717618 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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TAS-102, Irinotecan, and Bevacizumab in Pre-treated Metastatic Colorectal Cancer (TABAsCO), A Phase II Clinical Trial. ClinicalTrials.gov NCT04109924

Project description:Background: The efficacy of FOLFIRI plus an antiangiogenesis biologic agent as 2nd line therapy for metastatic colorectal adenocarcinoma is limited. TAS-102 is a novel oral antimetabolite with a distinct mechanism of action from fluoropyrimidines. We evaluated the antitumor efficacy of TAS-102, irinotecan and bevacizumab in patients with pre-treated, advanced colorectal adenocarcinoma in a multicenter, phase II, single-arm study. Methods: Patients with advanced colorectal adenocarcinoma who had progressed after oxaliplatin and fluoropyrimidine and were eligible for treatment with bevacizumab were treated with irinotecan, bevacizumab, and TAS-102 in 28-day cycles. The primary endpoint was progression-free survival (PFS). Results: We enrolled 35 evaluable patients. The study was positive. The median PFS was 7.9 (90% CI 6.2-11.8) months (vs. 6 months in historical control, p=0.018). The median overall survival was 16.5 (90% CI 9.8-17.5) months. Sixty-seven percent of patients experienced grade 3 or higher treatment-related adverse events. The most common toxicities were hematological (neutropenia) and gastrointestinal (diarrhea, nausea, and vomiting). Conclusions: Irinotecan, TAS-102 and bevacizumab is an active 2nd line therapy for patients with metastatic colorectal adenocarcinoma. Neutropenia is common and can affect dose density/intensity mandating use of G-CSF. A randomized study versus standard of care therapy is warranted.

2024-08-26 | GSE275628 | GEO

TAS-102 in Combination With Regorafenib or Fruquintinib for Third-line and Above Advanced Colorectal Cancer

Project description:This is a single-arm, multicentre real-world observational study of TAS-102 in combination with regorafenib or fruquintinib for third-line and above advanced colorectal cancer.

| 69888 | ecrin-mdr-crc

A phase II study of guadecitabien combined with irinotecan vs regorafenib or TAS-102 in previously treated metastatic colorectal cancer patients

Project description:A phase II study of guadecitabien combined with irinotecan vs regorafenib or TAS-102 in previously treated metastatic colorectal cancer patients

2023-03-31 | GSE226221 | GEO

A single-arm, single-center clinical study of tislelizumab combined with bevacizumab and TAS-102 and SBRT (BETTER) in the treatment of MSS metastatic Colorectal cancer

Project description:Interventions: Combined therapy group:Tislelizumab +TAS-102+ bevacizumab + stereotactic body radiotherapy Primary outcome(s): mPFS;ORR Study Design: Single arm

| 113359 | ecrin-mdr-crc

Fruquintinib Combined With TAS-102 in the Treatment of Patients With Advanced Metastatic CRC

Project description:This phase II study aims to explore the efficacy and safety of fruquintinib combined with TAS-102 in the third-line treatment of patients with advanced metastatic colorectal cancer.

| 2386605 | ecrin-mdr-crc

The application and exploration of Fruquintnib combined with TAS-102 and Stereotactic Body Radiotherapy(SBRT)for Third-line and Beyond Treatment of Metastatic Colorectal Cancer

Project description:Interventions: Cohort 1:Fruquintnib combined with TAS-102 and SBRT;Cohort 2:Fruquintnib combined with TAS-102 Primary outcome(s): Progression-free survival assessed by the investigator Study Design: Factorial

| 87000 | ecrin-mdr-crc

TAS-102 and Bevacizumab as third line chemotherapy for colorectal cancer. Phase 2 trial

Project description:Interventions: TAS-102: 35mg/m2 given orally twice daily on days 1-5 and 15-19 in a 28-day cycle. Bevacizumab: 5mg/kg given intravenously in a 2-week cycle Primary outcome(s): progression free survival Study Design: Single arm Non-randomized

| 2645202 | ecrin-mdr-crc

Expanded Access Study of TAS-102 in Patients With Metastatic Colorectal Cancer

Project description:The objective of the program is to provide access to TAS-102 to patients with metastatic colorectal cancer who are refractory to or failing standard chemotherapy, are new to therapy with TAS-102 and in whom therapy with TAS-102 is clinically indicated.

| 2177942 | ecrin-mdr-crc

TAS-102 and Bevacizumab as third line chemotherapy for colorectal cancer. Phase 2 trial

Project description:Interventions: TAS-102: 35mg/m2 given orally twice a day in a 28-day cycle, 2-week cycle of 5 days treatment followed by a 2-day rest period, and then a 14-day rest period Bevacizumab: 5mg/kg given intravenously in a 2-week cycle Primary outcome(s): progression free survival Study Design: Single arm Non-randomized

| 2637698 | ecrin-mdr-crc

Real-world Study of Patients with Metastatic Colorectal Cancer Receiving Investigational Bevacizumab in Combination with TAS-102 in the Third or Posterior Line

Project description:Interventions: Group 1:Bevacizumab combined with TAS-102 Primary outcome(s): overall survival;disease progress free survival Study Design: Single arm

| 81138 | ecrin-mdr-crc

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