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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)

RecruitingPhase 3Ages 18 Years - 75 YearsAllSuzhou Suncadia Biopharmaceuticals Co., Ltd.
NCT07229625 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. Locally advanced or recurrent/metastatic biliary adenocarcinoma that is inoperable and confirmed by histology or cytology; 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: 1. Other pathological types of cholangiocarcinoma other than adenocarcinoma; 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.
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What it tests

  • SHR-8068 Injection
  • Adebrelimab Injection
  • Gemcitabine Hydrochloride for Injection
  • Cisplatin Injection
  • Durvalumab Injection
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Where

1 site
The First Affiliated Hospital, College of Medicine, Zhejiang University
Hangzhou, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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