Chemotherapy Combined with Immunotherapy and Targeted Therapy in Cholangiocarcinoma

Recruiting

• Conditions: Cholangiocarcinoma
• Interventions: Drug: Gemcitabine combined with cisplatin or oxaliplatin; Drug: Gemcitabine combined with cisplatin or oxaliplatin, PD-1/L1 and TKI inhibitors

• Registration Number: NCT06718257
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Brief Summary

This study aims to validate the efficacy and safety of GP/GEMOX combined with PD-1/L1 inhibitors and TKI agents in patients with advanced cholangiocarcinoma through a multicenter, retrospective study to guide clinical practice.

Detailed Description

This study plans to enroll patients diagnosed with advanced cholangiocarcinoma. After confirming patients treated with GP/GEMOX or GP/GEMOX combined with PD-1/L1 and TKI agents as initial therapy, the investigators will collect relevant clinical data, including basic clinical information, laboratory data, imaging data, pathological data, and surgical data through an electronic medical record system.

Study Timeline

• Study Start: 2024-09-01
• Status Verified: 2024-11
• Study First Submitted: 2024-12-02
• Study First Submitted QC: 2024-12-02
• Study First Posted: 2024-12-05
• Last Update Submitted: 2025-02-05
• Last Update Posted: 2025-03-25
• Primary Completion: 2025-03-31
• Study Completion: 2025-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• Histologically or radiologically confirmed intrahepatic cholangiocarcinoma
• Initially treated with GP/GEMOX or GP/GEMOX combined with PD-1/L1 and TKI inhibitors

Exclusion Criteria

• Direct surgery after hospitalization
• Initial treatment combined with local therapies (radiotherapy, radiofrequency, particle implantation, TACE, etc.)
• Initial treatment involving other comprehensive therapeutic regimens

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Control group	Gemcitabine combined with cisplatin or oxaliplatin	Patients initially received GP/GEMOX regimen.
Experimental group	Gemcitabine combined with cisplatin or oxaliplatin, PD-1/L1 and TKI inhibitors	Patients initially received GP/GEMOX combined with PD-1/L1 and TKI inhibitors regimen.

Primary Outcome Measures

Name	Time	Method
Overall survival (OS)	1 year	Overall survival (OS) is defined as the time from cancer diagnosis to death from any cause.

Secondary Outcome Measures

Name	Time	Method
Progression-free survival (PFS)	1 year	Progression-free survival (PFS) is defined as the time from the start of treatment until disease progression or the emergence of new lesions.

Trial Locations

Locations (1)

2nd Affiliated Hospital, School of Medicine, Zhejiang University; 🇨🇳 Hangzhou, Zhejiang, China