NCT07229625RecruitingPhase 3
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)
Source: ClinicalTrials.gov · Last updated 28 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 604 (estimated)
- First submitted
- 13 Nov 2025
- Start date
- 21 Jan 2026
- Primary completion date
- Dec 2029
- Lead sponsor
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT07229625
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 604
- From 21 Jan 2026 to the primary completion date, Dec 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Those with concurrent biliary obstruction and at risk of biliary tract infection;
Other illness
- Malignant tumor of the ampulla;
- Have had or concurrently suffered from other malignant tumors;
- Those with any active or known autoimmune diseases.
Other
- Other pathological types of cholangiocarcinoma other than adenocarcinoma;
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The First Affiliated Hospital, College of Medicine, Zhejiang University Coordinator of this site? Confirm its status | Hangzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.