SHR-8068 with adebrelimab and platinum chemotherapy versus durvalumab with platinum chemotherapy for first-line advanced biliary tract cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, open-label, multicenter phase III trial compares SHR-8068 combined with adebrelimab and platinum-based chemotherapy against durvalumab combined with platinum-based chemotherapy as first-line therapy for inoperable locally advanced or metastatic biliary adenocarcinoma. Eligible patients have no prior systemic anti-tumor therapy, measurable disease per RECIST v1.1, and ECOG performance status 0–1. Participants receive gemcitabine and cisplatin with the assigned immunotherapy combination and are followed for efficacy and safety outcomes including response rates, progression-free survival, overall survival, and adverse events. The trial is sponsored by Suzhou Suncadia Biopharmaceuticals and is enrolling at The First Affiliated Hospital, College of Medicine, Zhejiang University.

Why it matters

Who can join: the full rules

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.

Where it's running

• The First Affiliated Hospital, College of Medicine, Zhejiang University
  Hangzhou, Zhejiang, China Recruiting

Study contacts

• Study coordinator: Xin Shi
• Email: xin.shi.xs3@hengrui.com
• Phone: +86-0518-82342973

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.