PULSAR Combined With Immunotherapy and Chemotherapy

Sponsor
Wang Xin
Study ID
NCT07291947
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Cholangiocarcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Iparomlimab and Tuvonralimab Injection (QL1706) — DRUG
    GC chemotherapy and Iparomlimab and Tuvonralimab Injection
  • PULSAR — RADIATION
    Personalized Ultra-fractionated Stereotactic Adaptive Radiotherapy

Study Details

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.

Key Dates

First listed
Dec 18, 2025
Start date
Nov 4, 2025
Status verified
Dec 2025
Primary completion
Sep 10, 2026
Completion
Sep 10, 2027

Study Design

Enrollment
60 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: PULSAR Combined with Immunotherapy and Chemotherapy
    PULSAR Combined with Immunotherapy and Chemotherapy

Primary Outcome Measure

Safety of immunotherapy and chemotherapy combined with PULSAR radiation therapy [ Time Frame: Baseline, every three weeks in the treatment period, 30 days and 3 months after treatment ]

Central Contacts

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