Actively Recruiting
PULSAR Combined With Immunotherapy and Chemotherapy
Led by Wang Xin · Updated on 2025-12-18
60
Participants Needed
1
Research Sites
96 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
PULSAR Combined With Immunotherapy and Chemotherapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent after understanding the study purpose and risks
- Age between 18 and 75 years
- Confirmed locally advanced or metastatic cholangiocarcinoma by pathology or cytology
- At least one measurable tumor lesion based on RECIST 1.1 criteria
- ECOG performance status of 0 or 1
- Expected survival time of 3 months or more
- Willing and able to comply with study treatments and follow-up
- No contraindications to PD-1, PD-L1 inhibitors, gemcitabine, cisplatin, or radiotherapy
- Organ function within specified limits for blood counts, liver enzymes, kidney function, and coagulation
- Women of childbearing potential agree to use contraception and have a negative pregnancy test before chemotherapy
- Women must not be breastfeeding
You will not qualify if you...
- Previous treatment with anti-PD-1 or anti-PD-L1 antibodies
- Use of any investigational drug within 4 weeks before starting study treatment
- Participation in other interventional clinical studies, except observational or follow-up studies
- Prior radiotherapy to the upper abdomen
- Uncontrolled severe diseases such as severe heart disease, stroke, uncontrolled diabetes or hypertension, infections, or active ulcers
- Active or suspected autoimmune diseases requiring systemic treatment
- Active tuberculosis infection within the past year or not fully treated
- Long-term systemic corticosteroid or immunosuppressive therapy
- Uncontrolled cardiac disease including significant heart failure, unstable angina, recent heart attack, or serious arrhythmias
- Dementia, altered mental state, or psychiatric disorders impairing consent or questionnaire completion
- Allergy to any study treatment components
- History of other cancers within 5 years except certain treated skin, prostate, or breast cancers
- Previous systemic therapy for cholangiocarcinoma
- Positive for hepatitis C virus or HIV antibodies
- Active infections requiring systemic treatment
- Other conditions deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
West China Hospital
Chengdu, Sichuan, China, 610041
Actively Recruiting
Research Team
D
Dr. shu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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