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)
A Phase III, Randomized, Controlled, Open-Label, Multicenter 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)
Suzhou Suncadia Biopharmaceuticals Co., Ltd.
604 participants
Jan 21, 2026
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria8
- Locally advanced or recurrent/metastatic biliary adenocarcinoma that is inoperable and confirmed by histology or cytology;
- No previous systemic anti-tumor treatment has been received;
- At least one measurable lesion that complies with the RECIST v1.1 standard;
- ECOG PS score: 0-1 point;
- The expected survival period is ≥ 3 months;
- Good organ function level;
- Negative blood pregnancy (for women of childbearing age) and not in the lactation period, adhering to efficient contraceptive requirements;
- Patients voluntarily joined this study and signed informed consent.
Exclusion Criteria5
- Other pathological types of cholangiocarcinoma other than adenocarcinoma;
- Malignant tumor of the ampulla;
- Have had or concurrently suffered from other malignant tumors;
- Those with concurrent biliary obstruction and at risk of biliary tract infection;
- Those with any active or known autoimmune diseases.
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Interventions
SHR-8068 injection.
Adebrelimab injection.
Gemcitabine Hydrochloride for injection.
Cisplatin injection.
Durvalumab injection.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07229625