SBRT + PD-1 Monoclonal Antibody in Unresectable Colorectal Liver Metastases

PHASE3RecruitingINTERVENTIONAL
Enrollment

24

Participants

Timeline

Start Date

April 10, 2025

Primary Completion Date

January 20, 2026

Study Completion Date

January 20, 2027

Conditions
Colorectal CancerLiver Metastases
Interventions
RADIATION

Stereotactic body radiation therapy

Stereotactic body radiation therapy (SBRT) is a highly precise form of external beam radiation therapy used to treat tumors in various parts of the body. Enrolled patients will initiate SBRT treatment within 2 weeks after the first course of chemotherapy. Intensity-modulated radiation therapy (IMRT) will be used, with the gross tumor volume (GTV) receiving a dose of 8-12 Gy in 5 fractions, resulting in a total dose of 40-60 Gy. The biologically effective dose (BED) is equivalent to 72-132 Gy. The treatment will be administered from Monday to Friday.

DRUG

PD-1 Monoclonal Antibody

PD-1 monoclonal antibody is a type of immunotherapy drug designed to treat various cancers by targeting the programmed death receptor-1 (PD-1) pathway.The PD-1 monoclonal antibody used in this study is sintilimab at a dose of 200 mg, administered via intravenous infusion on Day 1. Participants will be considered eligible only if they have completed four or more cycles of PD-1 monoclonal antibody treatment both before and after SBRT.

DRUG

Chemotherapy

Chemotherapy regimens based on fluorouracil (5-FU), such as CAPOX with a 3-week cycle or mFOLFOX6/FOLFIRI/FOLFOXIRI with a 2-week cycle, may be combined with targeted therapy. During chemotherapy or chemoradiotherapy, optimal supportive care will be provided.

Trial Locations (1)

510065

RECRUITING

Sixth Affiliated Hospital, Sun Yat-sen University, Guangzhou

All Listed Sponsors
lead

Jun Huang

OTHER