NCT06992648

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 302 (estimated)
• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is an investigator-initiated prospective, multicenter, randomized, controlled, open-label, non-inferiority trial evaluating the efficacy and safety of trifluridine/tipiracil + regorafenib vs trifluridine/tipiracil + bevacizumab in patients with refractory mCRC. The study process consists of: 1. Screening period. After signing the Informed Consent Form (ICF), patients enter the screening period for eligibility assessments. Test results obtained prior to signing the ICF may be used to evaluate inclusion/exclusion criteria if they meet the requirements, and repeat testing is not required after ICF signing. 2. Treatment period. Patients in the experimental arm will receive trifluridine/tipiracil + regorafenib, while those in the control arm will receive trifluridine/tipiracil + bevacizumab. Treatment will continue until the patient experiences disease progression, intolerable toxicity, investigator-determined inability to continue treatment, withdraws the ICF, death or end of study. 3. Follow-up period. After the withdrawal visit, a follow-up will be done every 8 weeks±7 days until death, withdrawal the ICF, loss to follow-up or end of study.

Conditions

• Colorectal Cancer Metastatic
• Colorectal Cancer Recurrent

Interventions

Type	Name	Description
DRUG	Trifluridine/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.
DRUG	Trifluridine/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).

Timeline

• Start date: 2025-04-01
• Primary completion: 2027-12-31
• Completion: 2027-12-31
• First posted: 2025-05-28
• Last updated: 2025-05-28

Locations

1 site across 1 country: China