Adebrelimab With or Without SHR-8068 in Combination With Cisplatin Plus Gemcitabine as First-line Treatment in Patients With Advanced Biliary Tract Cancer

Biliary Tract Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06465563
• Other study ID #: SHR-8068-201-BTC
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: July 1, 2024
• Est. completion date: December 30, 2026

Study information

• Verified date: June 2024
• Source: Suzhou Suncadia Biopharmaceuticals Co., Ltd.
• Contact: Xin Shi
• Phone: 0518-82342973
• Email: xin.shi.xs3[@]hengrui.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: December 30, 2026
• Est. primary completion date: December 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Biliary Tract Cancer
• Biliary Tract Neoplasms

Intervention

Drug:
• SHR-8068
SHR-8068
• Adebrelimab
Adebrelimab
• Cisplatin
Cisplatin
• Gemcitabine
Gemcitabine

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective Response Rate	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.	From Randomization to the first occurrence of disease progression or initiation of new anti-tumor therapy (up to approximately 14 months)
Secondary	Disease Control Rate	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.	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)
Secondary	Progression-Free-Survival (PFS)	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).	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)
Secondary	Duration of Response (DoR)	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).	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)