Clinical trial · Interventional
SHR-8068 in Combination With Adebrelimab, Bevacizumab, and Platinum-Based Chemotherapy as First-line Treatment in Patients With Advanced Biliary Tract Cancer
SHR-8068 in Combination With Adebrelimab, Bevacizumab, and Platinum-Based Chemotherapy for the First-Line Treatment of Advanced Biliary Tract Cancer: A Randomized and Exploratory Cohort, Open-label, Multicenter, Phase II Study
- 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)
Cohort A and B: This cohort aims to evaluate the efficacy and safety of SHR-8068 and Adebrelimab in combination with Cisplatin plus Gemcitabine (CisGem), compared with Adebrelimab in combination with CisGem, as first-line treatment in patients with Advanced Biliary Tract cancer. Cohort C: This cohort aims to evaluate the efficacy and safety of SHR-8068 and Adebrelimab and Bevacizumab in combination with Cisplatin Plus Gemcitabine (CisGem) as first-line treatment in patients with Advanced Biliary Tract cancer.
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 |
|---|---|---|---|
| Biliary Tract Cancer | Malignant Biliary Tract Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Adebrelimab | Drug | Adebrelimab | ALIAS |
| Bevacizumab Injection | Drug | Bevacizumab | ALIAS |
| Cisplatin | Drug | Cisplatin | ALIAS |
| Gemcitabine | Drug | Gemcitabine | ALIAS |
| SHR-8068 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Arm A: SHR-8068, Adebrelimab, Cisplatin and Gemcitabine
- interventionNames
- Drug: SHR-8068
- Drug: Adebrelimab
- Drug: Cisplatin
- Drug: Gemcitabine
- type
- EXPERIMENTAL
- label
- Arm B: Adebrelimab, Cisplatin and Gemcitabine
- interventionNames
- Drug: Adebrelimab
- Drug: Cisplatin
- Drug: Gemcitabine
- type
- EXPERIMENTAL
- label
- Arm C: SHR-8068, Adebrelimab, Bevacizumab, Cisplatin and Gemcitabine
- interventionNames
- Drug: SHR-8068
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age 18\~75 years old, both male and female; 2. Histologically or cytologically confirmed unresectable locally advanced, or recurrent/metastatic biliary tract adenocarcinoma (including gallbladder cancer, intrahepatic cholangiocarcinoma, and extrahepatic cholangiocarcinoma); 3. Has not received prior systemic anti-tumor therapy; 4. At least one measurable lesion based on RECIST v1.1 criteria; 5. ECOG PS score: 0-1 points; 6. Expected survival period ≥ 3 months; 7. Adequate organ function; 8. Must take one medically approved contraceptive measure; 9. Patients voluntarily joined the study and signed informed consent. Exclusion Criteria: 1. history or concurrently has other solid tumor; 2. Patients with liver tumor burden greater than 50% of total liver volume; 3. History of previous hepatic encephalopathy; 4. Patients with biliary obstruction , at risk of biliary tract infection; 5. Patients with undergone major surgical treatment within 4 weeks before randomization; 6. Patients with any active, known or suspected autoimmune disorder; 7. Patients with active pulmonary tuberculosis; 8. Patients with known history of HIV or active hepatitis; 9. Untreated central nervous system metastasis; 10. Pleural or peritoneal effusion with clinical symptoms; 11. Patients with poorly controlled cardiac clinical symptoms or disease; 12. Patients with abnormal coagulation function and bleeding tendency; 13. Known allergic reaction to Adalimumab or other monoclonal antibodies, or to the trial drug; 14. Patients with other potential factors that may affect the study results.
References
Publications (0)
Data not yet available