RecruitingPhase 1Phase 2NCT07291947

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


Sponsor

Wang Xin

Enrollment

60 participants

Start Date

Nov 4, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study tests a treatment approach that combines focused radiation (called PULSAR — Personalized Ultra-fractionated Stereotactic Adaptive Radiotherapy) with immunotherapy and chemotherapy (gemcitabine and cisplatin) for people with advanced bile duct cancer (cholangiocarcinoma) that cannot be surgically removed. **You may be eligible if...** - You are between 18 and 75 years old - You have locally advanced or metastatic cholangiocarcinoma confirmed by biopsy or cell testing - You have at least one measurable tumor - You are in good physical condition (ECOG 0–1) - Your expected survival is at least 3 months - Your organs function well enough for all three treatment types **You may NOT be eligible if...** - You have contraindications to immunotherapy drugs, gemcitabine, cisplatin, or radiation - You have conditions that make any part of the combined treatment unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGIparomlimab and Tuvonralimab Injection (QL1706)

GC chemotherapy and Iparomlimab and Tuvonralimab Injection

RADIATIONPULSAR

Personalized Ultra-fractionated Stereotactic Adaptive Radiotherapy


Locations(1)

West China Hospital

Chengdu, Sichuan, China

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NCT07291947


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