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Trial Title:
Adebrelimab With or Without SHR-8068 in Combination With Cisplatin Plus Gemcitabine as First-line Treatment in Patients With Advanced Biliary Tract Cancer
NCT ID:
NCT06465563
Condition:
Biliary Tract Cancer
Conditions: Official terms:
Biliary Tract Neoplasms
Gemcitabine
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
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
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
SHR-8068
Description:
SHR-8068
Arm group label:
Arm A: SHR-8068, Adebrelimab, Cisplatin and Gemcitabine
Intervention type:
Drug
Intervention name:
Adebrelimab
Description:
Adebrelimab
Arm group label:
Arm A: SHR-8068, Adebrelimab, Cisplatin and Gemcitabine
Arm group label:
Arm B: Adebrelimab, Cisplatin and Gemcitabine
Intervention type:
Drug
Intervention name:
Cisplatin
Description:
Cisplatin
Arm group label:
Arm A: SHR-8068, Adebrelimab, Cisplatin and Gemcitabine
Arm group label:
Arm B: Adebrelimab, Cisplatin and Gemcitabine
Intervention type:
Drug
Intervention name:
Gemcitabine
Description:
Gemcitabine
Arm group label:
Arm A: SHR-8068, Adebrelimab, Cisplatin and Gemcitabine
Arm group label:
Arm B: Adebrelimab, Cisplatin and Gemcitabine
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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
The First Affiliated Hospital，Zhejiang University School of Medicine
Address:
City:
Hangzhou
Zip:
310000
Country:
China
Status:
Recruiting
Contact:
Last name:
Tingbo Liang, Doctor
Phone:
+86-0571-87236685
Email:
liangtingbo@zju.edu.cn
Contact backup:
Last name:
Xueli Bai, Doctor
Phone:
+86-0571-87236685
Email:
shirleybai@zju.edu.cn
Start date:
July 2, 2024
Completion date:
December 30, 2026
Lead sponsor:
Agency:
Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Agency class:
Industry
Source:
Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06465563
