NCT06788171

PULSAR Combined With PD-1 Ab and Chemotherapy Plus Bev. for CRLM

A Phase II Trial of PULSAR (Personalized Ultrafractionated Stereotactic Adaptive Radiotherapy) Combined With PD-1 Ab and Chemotherapy Plus Bevacizumab for Colorectal Cancer Liver Metastasis

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 35 (estimated)
• Sponsor: Fujian Cancer Hospital · Other Government
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

To explore Progression-Free-Survival(FPS) of PULSAR(personalized ultrafractionated stereotactic adaptive radiotherapy) combined with PD-1 Ab and Chemotherapy plus Bevacizumabfor CRLM

Conditions

• Colorectal Cancer Liver Metastasis

Interventions

Type	Name	Description
RADIATION	Personalized Ultrafractionated Stereotactic Adaptive Radiotherapy	PULSAR (SBRT): A targeted radiation therapy delivering 5-10 Gy/fraction every 3 weeks (q3w) to the gross tumor volume (GTV), for 3 times.
DRUG	Bevacizumab	Bevacizumab: 5mg/kg, d1, q3w, 6 cycles.
DRUG	Capecitabine	Capecitabine: 1000mg/m2, d1-14, bid, q3w, 6 cycles.
DRUG	Oxaliplatin	Oxaliplatin: 130mg/m2, d1, q3w, 6 cycles.
DRUG	Sintilimab	Sintilimab: 200mg, d1, q3w, 6 cycles.

Timeline

• Start date: 2025-03-01
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2025-01-23
• Last updated: 2025-01-23

Locations

1 site across 1 country: China