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NOT YET RECRUITING
NCT07116577
PHASE2

Radiotherapy Combined QL1706, TAS-102 and Bevacizumab in mCRC

Sponsor: Jinan Central Hospital

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

37

Start Date

2025-08-31

Completion Date

2028-12-31

Last Updated

2025-08-11

Healthy Volunteers

No

Conditions

Interventions

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.

Locations (1)

Jinan Central Hospital

Jinan, Shandong, China