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

NCT06465563 | Recruiting Phase 2

• 1 other identifier: SHR-8068-201-BTC
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Biliary Tract Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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)

• 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)

• 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)

Study Arms (2)

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

EXPERIMENTAL

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

Arm B: Adebrelimab, Cisplatin and Gemcitabine

EXPERIMENTAL

Drug: Adebrelimab; Drug: Cisplatin; Drug: Gemcitabine

Interventions

SHR-8068 DRUG

SHR-8068

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

Adebrelimab DRUG

Adebrelimab

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

Cisplatin DRUG

Cisplatin

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

Gemcitabine DRUG

Gemcitabine

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

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• history or concurrently has other solid tumor;
• Patients with liver tumor burden greater than 50% of total liver volume;
• History of previous hepatic encephalopathy;
• Patients with biliary obstruction ， at risk of biliary tract infection;
• Patients with undergone major surgical treatment within 4 weeks before randomization;
• Patients with any active, known or suspected autoimmune disorder;
• Patients with active pulmonary tuberculosis;
• Patients with known history of HIV or active hepatitis;
• Untreated central nervous system metastasis;
• Pleural or peritoneal effusion with clinical symptoms;
• Patients with poorly controlled cardiac clinical symptoms or disease;
• Patients with abnormal coagulation function and bleeding tendency;
• Known allergic reaction to Adalimumab or other monoclonal antibodies, or to the trial drug;
• Patients with other potential factors that may affect the study results.

Sponsors & Collaborators

• Suzhou Suncadia Biopharmaceuticals Co., Ltd.: lead

Study Sites (1)

The First Affiliated Hospital，Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310000, China

RECRUITING

MeSH Terms

Conditions

Biliary Tract Neoplasms

Interventions

Cisplatin; Gemcitabine

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Biliary Tract Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Central Study Contacts

Xin Shi

CONTACT

0518-82342973; xin.shi.xs3@hengrui.com

Yujiao Wang

CONTACT

0518-82342973; yujiao.wang.yw250@hengrui.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: June 13, 2024
• First Posted: June 20, 2024
• Study Start: July 1, 2024
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: January 27, 2025

Record last verified: 2024-07

Locations

CN (1)