RecruitingPhase 3NCT06992648

Trifluridine/Tipiracil Plus Regorafenib vs Trifluridine/Tipiracil Plus Bevacizumab for Refractory Metastatic Colorectal Cancer

Trifluridine/Tipiracil Plus Regorafenib vs Trifluridine/Tipiracil Plus Bevacizumab for Refractory Metastatic Colorectal Cancer: A Randomized, Controlled, Open-Label, Non-Inferiority Trial

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Enrollment

302 participants

Start Date

Apr 1, 2025

Study Type

INTERVENTIONAL

Conditions

Colorectal Cancer Metastatic Colorectal Cancer Recurrent

Summary

The goal of this clinical trial is to demonstrate the non-inferiority of trifluridine/tipiracil + regorafenib vs trifluridine/tipiracil + bevacizumab in terms of progression free survival in patients with refractory metastatic colorectal cancer(mCRC) patients. It will also try to estimate the effect of trifluridine/tipiracil + regorafenib vs trifluridine/tipiracil + bevacizumab in terms of OS, ORR, and DCR in patients with refractory mCRC. Other secondary objectives are to compare the safety and tolerance, and the impact on QoL of trifluridine/tipiracil + regorafenib vs trifluridine/tipiracil + bevacizumab in patients with refractory mCRC.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two chemotherapy combinations — trifluridine/tipiracil (TAS-102) plus regorafenib, versus TAS-102 plus bevacizumab — as later-line treatment options for patients with advanced colorectal cancer. **You may be eligible if...** - You are 18 or older with confirmed advanced colorectal cancer (colon or rectum, adenocarcinoma) - Your cancer has been tested for RAS and BRAF mutations - You have already received prior chemotherapy regimens including fluoropyrimidine, irinotecan, oxaliplatin, and appropriate targeted therapies - You can swallow oral tablets and have adequate organ function - You are in reasonably good health (ECOG 0–1) **You may NOT be eligible if...** - Your cancer is of a histological type other than adenocarcinoma - You have not received the required prior chemotherapy regimens - You have poor kidney, liver, or blood count function - You are pregnant 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

DRUGTrifluridine/Tipiracil + Regorafenib

Trifluridine/tipiracil will be administered orally BID at a starting dose of 30 mg per square meter of body-surface area, on days 1 through 5 every 2 weeks. Regorafenib will be administered orally QD at a dose-escalation strategy (80 mg/day, followed by weekly increase of 40 mg to 120 mg/day), if no significant drug-related adverse events occurred and 120 mg/day for 21 days of a 28-day cycle.

DRUGTrifluridine/tipiracil + bevacizumab

Trifluridine/tipiracil will be administered orally BID at a starting dose of 35 mg per square meter of body-surface area, on days 1 through 5 every 2 weeks. Bevacizumab, at a dose of 5 mg per kilogram of body weight, will be administered IV every 2 weeks (day 1 and day 15).