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Clinical Trials in China / NCT06465563
Active, not recruiting Phase 2

SHR-8068 in Combination With Adebrelimab, Bevacizumab, and Platinum-Based Chemotherapy as First-line Treatment in Patients With Advanced Biliary Tract Cancer

NCT06465563 · tracked via the Priya Life Science China tracker
Sponsor
Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Phase
Phase 2
Started
2024-07-01
Last updated
2026-05-29

Condition(s) studied

Biliary Tract Cancer

Investigational drug(s) / intervention(s)

SHR-8068 →Adebrelimab →Cisplatin →Gemcitabine →Bevacizumab Injection →

SHR-8068: SHR-8068

Adebrelimab: Adebrelimab

Cisplatin: Cisplatin

Gemcitabine: Gemcitabine

Bevacizumab Injection: Bevacizumab injection.

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (2)

FacilityCityRegionStatus
Jiangsu Province Hospital (The First Affiliated Hospital with Nanjing Medical University) Nanjing Jiangsu
The First Affiliated Hospital,Zhejiang University School of Medicine Hangzhou Zhejiang

More Suzhou Suncadia Biopharmaceuticals Co., Ltd. trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06465563 on ClinicalTrials.gov ↗ ← All trials in China