NCT07291947

PULSAR Combined With Immunotherapy and Chemotherapy

Phase I/II Clinical Study of Personalized Ultra-fractionated Stereotactic Adaptive Radiotherapy (PULSAR) Combined With Immunotherapy and Chemotherapy in Patients With Cholangiocarcinoma

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Wang Xin · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to evaluate the efficacy and safety of PULSAR in combination with dual immune checkpoint inhibitors (PD-1 monoclonal antibody + CTLA-4 monoclonal antibody) and GC chemotherapy in patients with locally advanced or metastatic cholangiocarcinoma. The secondary objective of this study is to investigate the immunological impact of PULSAR combined with dual immune therapy (PD-1 monoclonal antibody + CTLA-4 monoclonal antibody) on the tumor microenvironment and systemic immune responses in cholangiocarcinoma patients.

Detailed description

After confirmation of eligibility, enrolled patients will undergo radiation CT simulation and planning per standard of care. IV contrast will be administered with CT simulation at the treating physician's discretion though is not required.

Conditions

• Cholangiocarcinoma

Interventions

Type	Name	Description
DRUG	Iparomlimab and Tuvonralimab Injection (QL1706)	GC chemotherapy and Iparomlimab and Tuvonralimab Injection
RADIATION	PULSAR	Personalized Ultra-fractionated Stereotactic Adaptive Radiotherapy

Timeline

• Start date: 2025-11-04
• Primary completion: 2026-09-10
• Completion: 2027-09-10
• First posted: 2025-12-18
• Last updated: 2025-12-18

Locations

1 site across 1 country: China