Biliary Tract Cancer
Conditions
Brief summary
This study 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.
Interventions
Sponsors
Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This study is a randomized, open-label, multicenter, Phase II clinical trial aimed at evaluating the efficacy and safety of Adebrelimab in combination with Cisplatin Plus Gemcitabine, with or without SHR-8068, as first-line treatment for advanced biliary tract cancer. The primary endpoint of the study is the Objective Response Rate (ORR), assessed by investigators based on RECISTv1.1 criteria
Eligibility
Sex/Gender
ALL
Age
18 Years to 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate | From Randomization to the first occurrence of disease progression or initiation of new anti-tumor therapy (up to approximately 14 months) | ORR is defined as the proportion of participants with Complete Response (CR) or Partial Response (PR), as determined by the investigator according to RECIST v1.1. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disease Control Rate | From Randomization to the first occurrence of disease progression or initiation of new anti-tumor therapy (up to approximately 14 months)] (up to approximately 14 months) | DCR is defined as the proportion of participants with Complete Response (CR), Partial Response (PR) or Stable Disease (SD), as determined by the investigator according to RECIST v1.1. |
| Progression-Free-Survival (PFS) | From randomization to the first occurrence of disease progression as determined by the investigator according to RECIST v1.1 or death from any cause (whichever occurs first) (up to approximately 14 months) | PFS is defined as the time from randomization to the first occurrence of disease progression as determined by the investigator according to RECIST v1.1 or death from any cause (whichever occurs first). |
| Duration of Response (DoR) | From the first occurrence of a confirmed objective response to disease progression as determined by the investigator according to RECIST v1.1 or death from any cause (whichever occurs first) (up to approximately 14 months) | DOR is defined as the time from the first occurrence of a confirmed objective response to disease progression as determined by the investigator according to RECIST v1.1 or death from any cause (whichever occurs first). |
Countries
China
Contacts
Primary ContactXin Shi
Backup ContactYujiao Wang
Outcome results
None listed