Actively Recruiting
A Study of Adebrelimab in Combination With Apatinib Gemcitabine and Cisplatin in Biliary Tract Malignancies
Led by First Affiliated Hospital of Fujian Medical University · Updated on 2024-04-30
35
Participants Needed
1
Research Sites
269 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Evaluating the efficacy and safety of adebrelimab in combination with apatinib, gemcitabine and cisplatin in the neoadjuvant treatment of patients with biliary tract malignancies.
CONDITIONS
Official Title
A Study of Adebrelimab in Combination With Apatinib Gemcitabine and Cisplatin in Biliary Tract Malignancies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years, male or female
- Diagnosed with gallbladder cancer or cholangiocarcinoma by tissue or cell examination
- Surgically resectable high-risk biliary malignancy confirmed by CT or MRI limited to liver, bile ducts, or nearby lymph nodes
- No distant spread of cancer (M0)
- No previous systemic therapy and no contraindications to surgery
- At least one measurable tumor lesion meeting size requirements
- ECOG performance status of 0 or 1
- Expected to live at least 12 weeks
- Normal major organ function meeting specific blood and biochemical test criteria
- Women of childbearing potential must test negative for pregnancy and use contraception during and 8 weeks after treatment
- Men must be sterilized or use contraception during and 8 weeks after treatment
- Willing to enroll voluntarily, comply, and attend follow-up visits
You will not qualify if you...
- Pregnant or breastfeeding women
- Autoimmune diseases, organ or stem cell transplant, or other cancers except cured basal cell carcinoma or cervical carcinoma in situ
- Impaired consciousness, inability to cooperate, or mental illness
- Participation in other clinical trials in the past 3 months
- Previous treatment with PD-1, PD-L1, or CTLA-4 inhibitors
- Prior major surgery, chemotherapy, or other treatments for the target lesion
- Use of interferon or immunosuppressive hormone therapy within 14 days before enrollment
- Allergic reaction to PD-1, PD-L1, CTLA-4 antibodies, or study drugs
- Bleeding from ruptured esophageal varices within 1 month
- Severe coagulation problems or bleeding risk preventing surgery
- Large uncontrollable ascites or pleural fluid and malaise
- Severe failure of major organs including liver, kidney, heart, lung, or brain
- Uncontrolled high blood pressure despite medication
- Severe cardiovascular disease or poor heart function
- Significant protein in urine
- Difficulty swallowing tablets or poor gastrointestinal absorption
- Other serious conditions that risk safety or study completion according to the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China, 350000
Actively Recruiting
Research Team
Z
Zhibo Zhang
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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