RecruitingPhase 2NCT05970705

Regorafenib Combined With TAS-102 Versus Regorafenib Monotherapy in Third or Later Line Therapy of mCRC

A Randomized, Controlled, Multicenter Phase II Trial of Regorafenib Combined With Trifluridine/Tipiracil Versus Regorafenib Monotherapy in Patients With Metastatic Colorectal Cancer Who Failed at Least Two Lines of Systematic Therapy


Sponsor

Fudan University

Enrollment

101 participants

Start Date

Jul 1, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study is to evaluate the clinical benefit of regorafenib combined with TAS-102 compared with regorafenib monotherapy in patients with metastatic colorectal cancer who have failed at least two lines of treatment, to explore the rationality of this combination therapy strategy and to obtain relevant survival and safety data.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two treatment approaches for people with metastatic colorectal cancer (bowel cancer that has spread) who have already tried at least two prior lines of chemotherapy. It compares the combination of regorafenib plus TAS-102 (two chemotherapy-type drugs) against regorafenib alone, to see if the combination is more effective. Both drugs work differently to help stop cancer growth and are already used as later-line options individually. **You may be eligible if...** - You have confirmed metastatic colorectal cancer that has progressed after at least one prior line of standard chemotherapy (including fluoropyrimidine, oxaliplatin, irinotecan, and bevacizumab) - You are physically well enough to carry out some daily activities (ECOG 0–2) - You have at least one measurable tumor on imaging - Your life expectancy is at least 12 weeks - Your blood counts and organ function are within acceptable ranges **You may NOT be eligible if...** - Your cancer has not been previously treated with standard first or second-line chemotherapy - You have severe organ problems that would prevent safe use of these drugs - You are pregnant or breastfeeding - You are currently enrolled in another clinical trial with conflicting treatments Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGRegorafenib

this anti-angiogenesis targeting drug is one of the standard third-line treatment options for patients with metastatic colorectal cancer

DRUGTrifluridine/Tipiracil

this chemotherapeutic drug is also one of the standard third-line treatment options for patients with metastatic colorectal cancer


Locations(1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

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NCT05970705


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