NCT06794086

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)

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Jun Huang · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

For patients with unresectable colorectal cancer liver metastasis, this study aims to explore whether the combination of stereotactic body radiation therapy (SBRT) and PD-1 monoclonal antibody can improve the objective response rate (ORR), achieve better long-term survival benefits, and enhance quality of life. Additionally, the study will investigate the efficacy and safety of SBRT combined with PD-1 monoclonal antibody for treating liver metastases, with the goal of providing high-level evidence-based medical evidence for the use of local hypofractionated radiotherapy combined with PD-1 monoclonal antibody in the treatment of unresectable colorectal cancer liver metastasis. This is a prospective, open-label, multicenter, single-arm, Phase II study. Patients with colorectal cancer will be eligible for enrollment if the hepatobiliary surgery team within the multidisciplinary team (MDT) deems the liver metastases unresectable, and the radiation oncology team within the MDT considers the liver metastases suitable for stereotactic body radiation therapy (SBRT). Enrolled patients will receive hypofractionated radiotherapy with a dose of 8-12 Gy in 5 fractions. Chemotherapy based on 5-FU combined with immunotherapy will be administered before and after radiotherapy. Eight weeks (±2 weeks) after the completion of radiotherapy, radiological assessment or multi-site liver biopsy will be performed. The MDT will then decide on the subsequent management: maintenance chemotherapy or watch-and-wait (W\&W) for patients achieving complete clinical response (cCR) or pathological complete response (pCR), or maintenance chemotherapy or discontinuation for patients who do not achieve cCR/pCR.

Conditions

• Colorectal Cancer
• Liver Metastases

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-04-10
• Primary completion: 2026-01-20
• Completion: 2027-01-20
• First posted: 2025-01-27
• Last updated: 2025-05-13

Locations

1 site across 1 country: China