NCT07353268

Phase Ib/II Study of QL1706 + Fruquintinib + SCRT vs. Standard Third-Line Therapy in Unresectable Liver-Metastatic pMMR/MSS Colorectal Cancer: Safety, Tolerability, and Efficacy.

A Phase Ib/II Study Evaluating the Safety, Tolerability, and Efficacy of Epalolitovoreli Monoclonal Antibody (QL1706) and Fruquintinib Combined With Short-Course Radiotherapy (SCRT) Versus Standard Third-Line Therapy in Patients With Unresectable Liver-Metastatic pMMR/MSS Colorectal Cancer.

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 76 (estimated)
• Sponsor: Tao Zhang · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study is designed to evaluate the safety, tolerability, and efficacy of Epalolitovoreli Monoclonal Antibody (QL1706) combined with Fruquintinib and Short-Course Radiotherapy (SCRT), compared with standard third-line therapy, in the treatment of patients with unresectable liver-metastatic pMMR/MSS colorectal cancer.

Conditions

• Colorectal Cancer

Interventions

Type	Name	Description
DRUG	QL1706 + Fruquintinib + Short-Course Ablative Radiotherapy (SCART)	Patients will receive the PD-1/CTLA-4 bispecific antibody Epalolitovoreli Monoclonal Antibody (QL1706) at a dose of 5 mg/kg by intravenous infusion every 3 weeks (Q3W). Patients will concomitantly receive oral Fruquintinib once daily (QD). The dose will be determined in a Phase Ib dose-escalation phase exploring 3 mg and 4 mg QD levels, using a modified 3+3 design to establish the Recommended Phase II Dose (RP2D). Patients will undergo Short-Course Ablative Radiotherapy (SCART) to the liver metastasis/metastases. The prescribed dose is 15 Gy in 3 fractions to the Gross Tumor Volume (GTV) and 45-72 Gy in 3 fractions to the Subclinical Target Volume (STV). Treatment with QL1706 and Fruquintinib will continue until disease progression, unacceptable toxicity, or other protocol-specified discontinuation criteria.
DRUG	Standard Third-Line Therapy	Patients will receive one of the following standard-of-care third-line therapies for metastatic colorectal cancer, selected by the investigator based on the patient's prior treatment history and comprehensive condition: Cetuximab with or without Irinotecan (for patients not previously treated with cetuximab). Regorafenib. Fruquintinib. Trifluridine/Tipiracil (TAS-102) with or without Bevacizumab.

Timeline

• Start date: 2026-01-21
• Primary completion: 2027-08-31
• Completion: 2027-12-31
• First posted: 2026-01-20
• Last updated: 2026-01-20

Locations

1 site across 1 country: China