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

PHASE2RecruitingINTERVENTIONAL
Enrollment

116

Participants

Timeline

Start Date

March 1, 2024

Primary Completion Date

March 1, 2026

Study Completion Date

March 1, 2028

Conditions
Microsatellite Stable Metastatic Colorectal Cancer
Interventions
RADIATION

Ultra-fractionated radiation therapy

Radiation therapy will be delivered every 3 weeks on the PULSAR schedule to achieve optimal local control of metastatic cancer and augment the effects of sintilimab.

DRUG

Sintilimab

Sintilimab will be given at 200 mg q3w every 3 weeks and schedule to the next day of every pulses of radiation.

DRUG

Standard systemic therapy

"First-line standard systemic therapies in cohort A include: FOLFOX/FOLIRI/XELOX+ bevacizumab, FOLFOX/FOLIRI/XELOX+cetuximab (KRAS/NRAS/BRAF WT and left-sided tumors only).~Second-line standard systemic therapies in cohort B include: FOLFOX/XELOX+ bevacizumab, FOLFOX/XELOX+cetuximab (KRAS/NRAS/BRAF WT), FOLFIRI/irinotecan+raltitrexed/irinotecan/+bevacizumab, FOLFIRI/irinotecan+raltitrexed/irinotecan/+cetuximab (KRAS/NRAS/BRAF WT), based on the previous first-line chemotherapy and adverse events."

Trial Locations (1)

Unknown

RECRUITING

Fudan University, Shanghai

All Listed Sponsors
lead

Fudan University

OTHER