Not Yet RecruitingPhase 2

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.

China76 participantsStarted 2026-01-21

Plain-language 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.

Who can participate

Age range18 Years – 75 Years

SexALL

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Inclusion criteria

✓. Signed written informed consent, and ability to comply with the scheduled visits and related procedures as specified in the protocol.
✓. Age ≥18 years and ≤75 years, male or female.
✓. Histologically or cytologically confirmed metastatic colorectal cancer with unresectable liver metastasis(es) measuring ≥5 cm in the longest diameter.
✓. Confirmed pMMR (proficient mismatch repair) or MSS (microsatellite stable) status by immunohistochemistry (IHC), next-generation sequencing (NGS), or PCR testing.
✓. Disease progression after, intolerance to, lack of access to, or refusal of standard second-line therapy.
✓. Baseline\* hematologic tests (within 7 days prior to the first dose of study drug) meeting the following criteria:
✓. Baseline serum biochemical tests (within 7 days prior to the first dose) meeting the following criteria:
✓. Baseline coagulation tests (within 7 days prior to the first dose) meeting the following criteria:

What they're measuring

Progression Free Survival（PFS）

Timeframe: an expected average of 6 months

Trial details

NCT IDNCT07353268

SponsorTao Zhang

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-08-31

Contact for this trial

Zhenyu Lin, MD

027-83262683 whxhlzy@hust.edu.cn

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