Chemotherapy Combined With Adebrelimab and Apatinib as the Perioperative Treatment in Patients With Biliary Tract Cancer

Phase 2

Recruiting

• Conditions: Resectable Intrahepatic Cholangiocarcinoma With High Risk of Recurrence
• Interventions: Drug: Adebrelimab, Apatinib, Gemcitabine, cisplatin

• Registration Number: NCT06280508
• Lead Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Brief Summary

This is a prospective, single-arm exploratory study to evaluate the efficacy and safety of chemotherapy combined with Adebrelimab and Apatinib as the perioperative treatment in Patients With Biliary Tract Cancer.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-02-20
• Study First Submitted QC: 2024-02-20
• Study First Posted: 2024-02-28
• Study Start: 2024-03-01
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-22
• Last Update Posted: 2024-04-23
• Primary Completion: 2027-03-31
• Study Completion: 2028-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• confirmed intrahepatic cholangiocarcinoma
• with Resectable tumor lesion
• no contraindications to surgery
• with high risk of tumour recurrence
• No prior systemic therapy for intrahepatic cholangiocarcinoma.
• ECOG Performance Status of 0 or 1
• Child-Pugh Class: Grade A

Exclusion Criteria

• History of gastrointestinal hemorrhage within 6 months prior to the start of study treatment or clear tendency of gastrointestinal hemorrhage
• Abdominal fistula, gastrointestinal perforation or intraperitoneal abscess within 6 months prior to the start of study treatment
• Known genetic or acquired hemorrhage or thrombotic tendency
• Thrombosis or thromboembolic event within 6 months prior to the start of study treatment
• Cardiac clinical symptom or disease that is not well controlled
• Hypertension that can not be well controlled through antihypertensive drugs

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
treatment arm	Adebrelimab, Apatinib, Gemcitabine, cisplatin	-

Primary Outcome Measures

Name	Time	Method
1-year EFS rate	Up to approximately 3 years	1-year event-free survival rate

Secondary Outcome Measures

Name	Time	Method
R0 Resection rate	Up to approximately 3 years	R0 Resection rate
EFS	Up to approximately 3 years	Event-free survival
RFS	Up to approximately 3 years	Recurrence-free survival
OS	Up to approximately 3 years	Overall survival

Trial Locations

Locations (1)

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University; 🇨🇳 Guangzhou, China/Guangdong, China