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A randomized, controlled, multicenter clinical trial of Fruquintinib combined with TAS-102 with Fruquintinib in the treatment of advanced metastatic colorectal cancer with standard treatment failure

ABSTRACT: Interventions: Experimental group:Give fruquintinib combined with TAS-102;Control Group:fruquintinib Primary outcome(s): Progression-free survival Study Design: Parallel

DISEASE(S): Colorectal Cancer

PROVIDER: 2707127 | 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

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

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

Fruquintinib With PD-1 Inhibitors Versus TAS-102 With Bevacizumab in Late-Line mCRC

Project description:Fruquintinib with PD-1 inhibitors (FP) and TAS-102 with bevacizumab (TB) are two common therapies for patients with previous-treated metastatic colorectal cancer (mCRC). However, it’s still not clear that which therapy can bring better prognosis. Our study sought to investigate the efficacy and safety of fruquintinib with PD-1 Inhibitors versus TAS-102 with bevacizumab in Late-Line mCRC between July 2019 to October 2022July 2019 and June 2021 at the Hunan Cancer Hospital.

| 91504 | ecrin-mdr-crc

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

Fruquintinib in the Cross-line Treatment of Refractory mCRC

Project description:This is a real-world study. Patients with metastatic colorectal cancer who have progressed (PD) after third-line treatment with fruquintinib combined with PD-1 inhibitors will receive fruquintinib combined with TAS-102 as fourth-line therapy. The objective of this study was to observe the efficacy and safety of cross-line（from third to fourth line）treatment with fruquinitinib.

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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 Oxaliplatin for the Treatment of Refractory Stage IV Colon Cancer

Project description:This phase II trial studies how well TAS-102 and oxaliplatin work in treating patients with stage IV colon cancer. Drugs used in chemotherapy, such as TAS-102 and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.

| 2332004 | ecrin-mdr-crc

Phase II study of TAS-102 in patients with metastatic colorectal cancer

Project description:Intervention name : TAS-102 Dosage And administration of the intervention : TAS-102 70 mg/m2 was administered orally twice a day for 5 days followed by 2 day rest and repeated two times this procedure. Control intervention name : Placebo Dosage And administration of the control intervention : Placebo was administered orally twice a day for 5 days followed by 2 day rest and repeated two times this procedure. Primary outcome(s): Overall survival To evaluate the overall survivals of TAS-102 versus placebo in patients with chemotherapy-refractory metastatic colorectal cancer Study Design: Randomized, double-blind, placebo-controlled, parallel-group comparative study

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A Vaccine (PolyPEPI1018 Vaccine) and TAS-102 for the Treatment of Metastatic Colorectal Cancer

Project description:This phase Ib trial studies the safety and side effects of a vaccine (PolyPEPI1018 vaccine) in combination with TAS-102 in treating patients with colorectal that has spread to other parts of the body (metastatic). PolyPEPI1018 peptide vaccine is used to immunize against proteins present on the surface of tumor cells. This vaccine can activate the body’s immune cells, called T cells. T cells fight infections and can also kill cancer cells. TAS-102 may help block the formation of growths that may become cancer. Giving PolyPEPI1018 and TAS-102 may kill more tumor cells in patients with metastatic colorectal cancer.

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