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Recruiting Phase 2 NCT06841159

Personalized Ultrafractionated Stereotactic Adaptive Radiotherapy (PULSAR ) Combined With Anti-PD1,Chemotherapy and Target Therapy for Metastatic Colorectal Cancer

Trial Parameters

Condition Microsatellite Stable Metastatic Colorectal Cancer
Sponsor Fudan University
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 116
Sex ALL
Min Age 18 Years
Max Age 75 Years
Start Date 2024-03-01
Completion 2026-03-01
Interventions
Ultra-fractionated radiation therapySintilimabStandard systemic therapy

Brief Summary

To improve the survival in patients with microsatellite stable metastatic colorectal cancer (MSS mCRC) by loco-regional therapy with personalized ultra-fractionated radiation plus immunotherpy.

Eligibility Criteria

Inclusion Criteria: * Patient is 18-75 years old at the time of signing the informed consent form. * ECOG performance status 0-1. * Histopathological confirmed MSS/pMMR adenocarcinoma of the colon or rectum. * Distant metastasis lesions are no more than 10 and all sites of disease can be safely treated based on a pre-plan. * At least one evaluable metastatic lesion for radiotherapy and evaluation according to RECIST 1.1. * No prior radiotherapy within 6 month. * Previous system therapy. Patients Group Cohort A: participants who have not previously been treated with first-line chemotherapy. Cohort B: Patients with disease progression after first-line chemotherapy or stopped first-line therapy due to unacceptable toxic effects . * Has an investigator determined life expectancy of at least 24 weeks. * Demonstrate adequate organ function (bone marrow, liver, kidney and clotting function) within 7 days before the first administration without using blood products or hematopoietic stimulating

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