Clinical trial · Interventional
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Biliary Tract Cancer | Malignant Biliary Tract Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Adebrelimab Injection | Drug | Adebrelimab | ALIAS |
| Cisplatin Injection | Drug | Cisplatin | ALIAS |
| Durvalumab Injection | Drug | Durvalumab | ALIAS |
| Gemcitabine Hydrochloride for Injection | Drug | Gemcitabine | ALIAS |
| SHR-8068 Injection | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- SHR-8068 + Adebrelimab + Cisplatin and Gemcitabine Group
- interventionNames
- Drug: SHR-8068 Injection
- Drug: Adebrelimab Injection
- Drug: Gemcitabine Hydrochloride for Injection
- Drug: Cisplatin Injection
- type
- ACTIVE_COMPARATOR
- label
- Durvalumab + Cisplatin and Gemcitabine Group
- interventionNames
- Drug: Gemcitabine Hydrochloride for Injection
- Drug: Cisplatin Injection
- Drug: Durvalumab Injection
Primary outcomes (1)
- measure
- Overall Survival (OS)
- timeFrame
- Up to 15 months.
Secondary outcomes (8)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available