Adebrelimab With or Without SHR-8068 in Combination With Cisplatin Plus Gemcitabine as First-line Treatment in Patients With Advanced Biliary Tract Cancer: A Randomized, Open-label, Multicenter, Phase II Study

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• Age 18\

⁃ 75 years old, both male and female;

• Histologically or cytologically confirmed unresectable locally advanced, or recurrent/metastatic biliary tract adenocarcinoma (including gallbladder cancer, intrahepatic cholangiocarcinoma, and extrahepatic cholangiocarcinoma);

• Has not received prior systemic anti-tumor therapy;

• At least one measurable lesion based on RECIST v1.1 criteria;

• ECOG PS score: 0-1 points;

• Expected survival period ≥ 3 months;

• Adequate organ function;

• Must take one medically approved contraceptive measure;

• Patients voluntarily joined the study and signed informed consent.

Locations
Other Locations
China
The First Affiliated Hospital,Zhejiang University School of Medicine
RECRUITING
Hangzhou
Contact Information
Primary
Xin Shi
xin.shi.xs3@hengrui.com
0518-82342973
Backup
Yujiao Wang
yujiao.wang.yw250@hengrui.com
0518-82342973
Time Frame
Start Date: 2024-07-01
Estimated Completion Date: 2026-12-30
Participants
Target number of participants: 80
Treatments
Experimental: Arm A: SHR-8068, Adebrelimab, Cisplatin and Gemcitabine
Experimental: Arm B: Adebrelimab, Cisplatin and Gemcitabine
Related Therapeutic Areas
Sponsors
Leads: Suzhou Suncadia Biopharmaceuticals Co., Ltd.

This content was sourced from clinicaltrials.gov

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