Actively Recruiting
Cadonilimab With Chemotherapy in Treating Advanced Biliary Cancer
Led by West China Hospital · Updated on 2023-08-07
65
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this single-arm, Phase II interventional clinical trial is to test the safety and effectiveness of a combination treatment using the Cadonilimab with Gemcitabine and Cisplatin in patients with unresectable, locally advanced or metastatic biliary tract malignancies. The main questions it aims to answer are: * Is this combined treatment protocol safe for these patients? * Is this combined treatment protocol effective in treating these patients? Participants will be given a combination treatment of Cadonilimab, Gemcitabine, and Cisplatin. Researchers will monitor their health conditions to assess the safety and effectiveness of this treatment protocol.
CONDITIONS
Official Title
Cadonilimab With Chemotherapy in Treating Advanced Biliary Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Written informed consent obtained before any experimental procedures
- Age between 18 and 75 years, any gender
- Histologically or cytologically confirmed unresectable locally advanced or metastatic biliary tumors (intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, gallbladder carcinoma)
- No prior systemic treatment, curative surgery, or adjuvant therapy within the past 6 months
- Expected survival time greater than 3 months
- At least one measurable lesion per RECIST 1.1 criteria
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1
- Adequate organ function meeting specific laboratory criteria including blood counts, liver and kidney function, coagulation, thyroid, and cardiac enzymes
- Negative pregnancy test for premenopausal females within 3 days before first dose
- Use of effective contraception with less than 1% failure rate during treatment and for 120 days after last dose if pregnancy risk exists
You will not qualify if you...
- Malignant diseases other than extrahepatic bile duct cancer, except certain skin cancers, within past 5 years
- Tumors located in the ampulla of Vater
- Participation in other interventional clinical studies or investigational treatment within 4 weeks prior to first dose
- Previous therapy with anti-PD-1, anti-PD-L1, anti-PD-L2 agents, or other T-cell receptor-targeting drugs
- Previous palliative radiotherapy for biliary tumors (except postoperative adjuvant radiotherapy)
- Use of traditional Chinese medicine or immune modulatory drugs with anti-tumor indications within 2 weeks prior to first dose
- Active autoimmune diseases requiring systemic treatment within 2 years or primary immunodeficiency
- Systemic corticosteroid or immunosuppressive therapy within 4 weeks prior to first dose (physiological doses excepted)
- Uncontrolled pleural effusion or ascites requiring drainage or recent increase
- Prior solid organ transplantation (excluding corneal)
- Known hypersensitivity to study drug or components
- Insufficient recovery from prior treatment toxicities
- HIV infection
- Untreated active hepatitis B or hepatitis C infection
- Live attenuated vaccine within 4 weeks prior to first dose
- Pregnant or lactating women
- Severe or uncontrolled systemic diseases including significant cardiac abnormalities, unstable angina, recent arterial thrombotic events, recent major surgery, poor blood pressure control, active infections including tuberculosis, liver diseases, poorly controlled diabetes, psychiatric disorders hindering compliance
- Any medical history or conditions that may interfere with study participation or results as determined by 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, Sichuan University
Chengdu, Sichuan, China, 610041
Actively Recruiting
Research Team
T
Tao Wang
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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