NCT07502014

A Clinical Study of Iparomlimab and Tuvonralimab Combined With Fruquintinib and Heterogeneous Radiotherapy Versus Fruquintinib as Third-Line and Subsequent-Line Treatment for Metastatic Colorectal Cancer

A Randomized, Parallel, Open-Label, Multicenter Clinical Study of Iparomlimab and Tuvonralimab Combined With Fruquintinib and Heterogeneous Radiotherapy Versus Fruquintinib as Third-Line and Subsequent-Line Treatment for Metastatic Colorectal Cancer

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Huazhong University of Science and Technology · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, parallel, open-label, multicenter exploratory clinical study designed to investigate the efficacy and safety of iparomlimab and tuvonralimab in combination with fruquintinib plus heterogeneous radiotherapy, compared with fruquintinib monotherapy, as the third-line and subsequent-line treatment for patients with oligometastatic colorectal cancer.

Conditions

• Metastatic Colorectal Cancer (CRC)
• mCRC

Interventions

Type	Name	Description
DRUG	Iparomlimab and Tuvonralimab (QL1706)	Dual immune checkpoint inhibitor antibody targeting PD-1 and CTLA-4
DRUG	Fruquintinib	TKI
RADIATION	Heterogeneous Radiotherapy	High-dose radiotherapy (SBRT): 8-10 Gy × 5 fractions, administered every other day (qod), to be completed within 10 days. Low-dose radiotherapy (for other lesions): 2 Gy per fraction, one fraction per lesion.

Timeline

• Start date: 2026-05-01
• Primary completion: 2028-12-31
• Completion: 2029-12-31
• First posted: 2026-03-30
• Last updated: 2026-03-30