RecruitingPhase 3NCT06794086

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

SBRT Combined With PD-1 Monoclonal Antibody in Unresectable Colorectal Liver Metastases: A Prospective, Multicenter, Single-arm, Phase II Clinical Study (SPARKLE-L)

Sponsor

Jun Huang

Enrollment

24 participants

Start Date

Apr 10, 2025

Study Type

INTERVENTIONAL

Conditions

Colorectal, Cancer Liver Metastases

Summary

To explore the efficacy and safety of stereotactic body radiation therapy (SBRT) combined with PD-1 monoclonal antibody in the treatment of unresectable colorectal cancer liver metastasis through a prospective study, providing high-level evidence-based medical evidence for the use of SBRT combined with PD-1 inhibitors in the treatment of unresectable colorectal cancer liver metastasis.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether adding a targeted radiation technique called SBRT (stereotactic body radiation therapy) to immunotherapy (a PD-1 inhibitor drug) can shrink liver tumors in people with colorectal cancer that has spread to the liver and cannot be surgically removed. **You may be eligible if...** - You are 18–75 years old with confirmed colorectal cancer that has spread to the liver and cannot be surgically removed - Your liver tumors are 6 cm or smaller in maximum diameter - Your cancer has the pMMR/MSS molecular profile - You have not previously received liver radiation **You may NOT be eligible if...** - Your cancer has spread widely beyond the liver to multiple organs - Your liver tumor is larger than 6 cm - You have received prior liver radiation that would overlap with the planned radiation area Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONStereotactic 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.

DRUGPD-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.

DRUGChemotherapy

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.