Actively Recruiting
Anti-PD-1/PD-L1 Antibodies Plus Gemcitabine and Cisplatin for Advanced CCA
Led by Shanghai Zhongshan Hospital · Updated on 2025-12-18
50
Participants Needed
1
Research Sites
284 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is a prospective, observational study designed to analyze the safety, tolerability, and efficacy of first-line treatment using the combination of gemcitabine and cisplatin plus anti-PD-1/PD-L1 antibodies for patients with advanced cholangiocarcinoma.
CONDITIONS
Official Title
Anti-PD-1/PD-L1 Antibodies Plus Gemcitabine and Cisplatin for Advanced CCA
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years old or older, male or female
- Histologically or cytologically confirmed locally advanced or metastatic biliary tract cancer (including intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, or gallbladder cancer) not suitable for curative surgery or local therapies
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
- Written informed consent provided
- Adequate function of important organs
- Expected survival of at least 12 weeks
- Use of medically accepted contraception during the study and for 3 months after study treatment if non-surgically sterilized or of childbearing potential
You will not qualify if you...
- Active autoimmune disease or history of autoimmune disease (e.g., autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, nephritis, thyroid hyperfunction, vitiligo)
- Use of immunosuppressive agents or systemic hormonal therapy for immunosuppression (over 10 mg/day of prednisone or equivalent) within 2 weeks before enrollment
- Uncontrolled clinical symptoms or diseases
- Significant bleeding symptoms or bleeding tendency within 3 months before randomization
- Arterial or venous thrombosis within 6 months before randomization
- Other factors affecting study results or patient safety, such as alcohol or drug abuse, serious diseases requiring treatment, mental illness, or serious laboratory abnormalities
- Known hypersensitivity to gemcitabine, cisplatin, or platinum-containing compounds
- Significant hearing impairment (grade 2 or higher) or peripheral neuropathy (grade 2 or higher) contraindicating cisplatin treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Zhongshan Hospital Fudan university
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
Research Team
Q
Qinghai Ye, PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here