NCT07116577

Radiotherapy Combined QL1706, TAS-102 and Bevacizumab in mCRC

A Single-Arm, Exploratory Study of Palliative Radiotherapy Combined With Iparomlimab and Tuvonralimab, Trifluridine/Tipiracil (TAS-102), and Bevacizumab in Later-Line Treatment of Advanced Colorectal Cancer

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 37 (estimated)
• Sponsor: Jinan Central Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This single-center, single-arm, prospective study plans to enroll patients with advanced colorectal cancer who have failed first-line or higher systemic therapies. Participants will receive a combination of iparomlimab and tuvonralimab (QL1706), trifluridine/tipiracil (TAS-102), bevacizumab, and palliative radiotherapy. The efficacy and safety of this combination therapy will be evaluated by assessing objective response rate (ORR), progression-free survival (PFS), overall survival (OS), disease control rate (DCR), and safety profile.

Conditions

• mCRC

Interventions

Type	Name	Description
RADIATION	Palliative radiotherapy	Conventional fractionation, low-dose hypofractionated radiotherapy, or high-dose hypofractionated radiotherapy may be employed.
DRUG	Iparomlimab and tuvonralimab	5 mg/kg, intravenously infused on Day 1 of each cycle, administered every 3 weeks (with each cycle defined as 21 days).
DRUG	TAS-102	35 mg/m², orally twice daily on Days 1 to 5 and Days 8 to 12 of each cycle, with each cycle spanning 28 days (4 weeks).
DRUG	Bevacizumab	7.5 mg/kg via intravenous infusion on Day 1 of each 21-day cycle.

Timeline

• Start date: 2025-08-31
• Primary completion: 2027-08-31
• Completion: 2028-12-31
• First posted: 2025-08-11
• Last updated: 2025-08-11

Locations

1 site across 1 country: China