Actively Recruiting
A Phase III Study of SHR-8068 in Combination With Adebrelimab and Platinum-Containing Chemotherapy Versus Durvalumab in Combination With Platinum-Containing Chemotherapy as First-line Treatment for Advanced Biliary Tract Cancer (BTC)
Led by Suzhou Suncadia Biopharmaceuticals Co., Ltd. · Updated on 2026-01-28
604
Participants Needed
1
Research Sites
201 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is a randomized, open-label, multicenter phase III clinical trial, aiming to evaluate the efficacy and safety of SHR-8068 combined with adbelimab and platinum-based chemotherapy in contrast to varicumab combined with platinum-based chemotherapy in the first-line treatment of patients with advanced BTC.
CONDITIONS
Official Title
A Phase III Study of SHR-8068 in Combination With Adebrelimab and Platinum-Containing Chemotherapy Versus Durvalumab in Combination With Platinum-Containing Chemotherapy as First-line Treatment for Advanced Biliary Tract Cancer (BTC)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Locally advanced or recurrent/metastatic biliary adenocarcinoma that is inoperable and confirmed by histology or cytology
- No previous systemic anti-tumor treatment received
- At least one measurable lesion per RECIST v1.1 criteria
- ECOG performance status score of 0 or 1
- Expected survival of at least 3 months
- Good organ function
- Negative pregnancy test for women of childbearing age and adherence to effective contraception
- Voluntary participation with signed informed consent
You will not qualify if you...
- Pathological types of cholangiocarcinoma other than adenocarcinoma
- Malignant tumor of the ampulla
- Current or past other malignant tumors
- Concurrent biliary obstruction with risk of biliary tract infection
- Any active or known autoimmune diseases
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital, College of Medicine, Zhejiang University
Hangzhou, Zhejiang, China, 310003
Actively Recruiting
Research Team
X
Xin Shi
CONTACT
X
Xin Xu
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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