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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-01

Study Completion Date

2026-12-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Biliary Tract Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm A: SHR-8068, Adebrelimab, Cisplatin and Gemcitabine

Group Type EXPERIMENTAL

SHR-8068

Intervention Type DRUG

SHR-8068

Adebrelimab

Intervention Type DRUG

Adebrelimab

Cisplatin

Intervention Type DRUG

Cisplatin

Gemcitabine

Intervention Type DRUG

Gemcitabine

Arm B: Adebrelimab, Cisplatin and Gemcitabine

Group Type EXPERIMENTAL

Adebrelimab

Intervention Type DRUG

Adebrelimab

Cisplatin

Intervention Type DRUG

Cisplatin

Gemcitabine

Intervention Type DRUG

Gemcitabine

Interventions

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SHR-8068

Intervention Type DRUG

Adebrelimab

Intervention Type DRUG

Cisplatin

Intervention Type DRUG

Gemcitabine

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No