NCT06841159

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

Phase 2 Study of Personalized Ultrafractionated Stereotactic Adaptive Radiotherapy (PULSAR ) Combined With Anti-PD1, Chemotherapy and Target Therapy for Metastatic Colorectal Cancer(iPULSAR-CRC)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 116 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

IPULSAR-CRC is a prospective, single-arm, two-cohort, investigator-initiated phase II trial to investigate the efficacy and safety of Personalized Ultrafractionated Stereotactic Adaptive Radiotherapy (PULSAR ) plus sintilimab in combination with standard systemic therapy in paitents with microsatellite stable metastatic colorectal cancer (MSS mCRC). Eligible patients will be assigned to two cohorts according to previous treatment: a first-line cohort A and a second-line cohort B. Patients in both arms will receive PULSAR, administered in 5 fractions of 6-10 Gy each (30-100 Gy total) at 3 week intervals. Sintilimab will be administered 200mg every 3 weeks and schedule to the next day of every pulses of radiation. Standard systemic therapy will be administered based on previous chemotherapy and adverse reactions to chemotherapy agents and at the discretion of the oncologist.The survival benefits, response rates, and adverse effects will be analyzed.

Conditions

• Microsatellite Stable Metastatic Colorectal Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-03-01
• Primary completion: 2026-03-01
• Completion: 2028-03-01
• First posted: 2025-02-24
• Last updated: 2025-02-24

Locations

1 site across 1 country: China