Actively Recruiting
Adebrelimab With or Without SHR-8068 in Combination With Cisplatin Plus Gemcitabine as First-line Treatment in Patients With Advanced Biliary Tract Cancer
Led by Suzhou Suncadia Biopharmaceuticals Co., Ltd. · Updated on 2025-01-27
80
Participants Needed
1
Research Sites
130 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study aims to evaluate the efficacy and safety of SHR-8068 and Adebrelimab in Combination With Cisplatin Plus Gemcitabine(CisGem), compared with Adebrelimab in Combination With CisGem, as first-line treatment in patients with Advanced Biliary Tract cancer.
CONDITIONS
Official Title
Adebrelimab With or Without SHR-8068 in Combination With Cisplatin Plus Gemcitabine as First-line Treatment in Patients With Advanced Biliary Tract Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 75 years, male or female
- Histologically or cytologically confirmed unresectable locally advanced, recurrent, or metastatic biliary tract adenocarcinoma
- No prior systemic anti-tumor therapy received
- At least one measurable lesion per RECIST v1.1
- ECOG performance status score of 0 or 1
- Expected survival of at least 3 months
- Adequate organ function
- Use of one medically approved contraceptive method
- Voluntary participation with signed informed consent
You will not qualify if you...
- History or presence of other solid tumors
- Liver tumor burden exceeding 50% of total liver volume
- History of previous hepatic encephalopathy
- Presence of biliary obstruction with risk of infection
- Major surgery within 4 weeks before randomization
- Any active or suspected autoimmune disorder
- Active pulmonary tuberculosis
- Known HIV infection or active hepatitis
- Untreated central nervous system metastases
- Clinically symptomatic pleural or peritoneal effusion
- Poorly controlled cardiac symptoms or disease
- Abnormal blood clotting or bleeding tendency
- Known allergy to Adalimumab, other monoclonal antibodies, or trial drugs
- Other factors potentially affecting study results
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital，Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310000
Actively Recruiting
Research Team
X
Xin Shi
CONTACT
Y
Yujiao Wang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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