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.
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.
1. History of allergy to any study drug, including Epalolitovoreli Monoclonal Antibody and Fruquintinib.
Ventricular arrhythmias or other uncontrolled arrhythmias requiring medical intervention (e.g., antiarrhythmic medication).
Severe conduction disorders (e.g., third-degree atrioventricular block).
Heart rate-corrected QT interval (QTc, calculated using Fridericia's formula) ≥480 ms.
Tao Zhang
Lead sponsor
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Sponsor institution