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)
NCT ID: NCT07229625
Last Updated: 2026-01-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
604 participants
INTERVENTIONAL
2026-01-21
2029-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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SHR-8068 + Adebrelimab + Cisplatin and Gemcitabine Group
SHR-8068 Injection
SHR-8068 injection.
Adebrelimab Injection
Adebrelimab injection.
Gemcitabine Hydrochloride for Injection
Gemcitabine Hydrochloride for injection.
Cisplatin Injection
Cisplatin injection.
Durvalumab + Cisplatin and Gemcitabine Group
Gemcitabine Hydrochloride for Injection
Gemcitabine Hydrochloride for injection.
Cisplatin Injection
Cisplatin injection.
Durvalumab Injection
Durvalumab injection.
Interventions
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SHR-8068 Injection
SHR-8068 injection.
Adebrelimab Injection
Adebrelimab injection.
Gemcitabine Hydrochloride for Injection
Gemcitabine Hydrochloride for injection.
Cisplatin Injection
Cisplatin injection.
Durvalumab Injection
Durvalumab injection.
Eligibility Criteria
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Inclusion Criteria
2. No previous systemic anti-tumor treatment has been received;
3. At least one measurable lesion that complies with the RECIST v1.1 standard;
4. ECOG PS score: 0-1 point;
5. The expected survival period is ≥ 3 months;
6. Good organ function level;
7. Negative blood pregnancy (for women of childbearing age) and not in the lactation period, adhering to efficient contraceptive requirements;
8. Patients voluntarily joined this study and signed informed consent.
Exclusion Criteria
2. Malignant tumor of the ampulla;
3. Have had or concurrently suffered from other malignant tumors;
4. Those with concurrent biliary obstruction and at risk of biliary tract infection;
5. Those with any active or known autoimmune diseases.
18 Years
75 Years
ALL
No
Sponsors
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Suzhou Suncadia Biopharmaceuticals Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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The First Affiliated Hospital, College of Medicine, Zhejiang University
Hangzhou, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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SHR-8068-303
Identifier Type: -
Identifier Source: org_study_id
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