NCT06718257

Chemotherapy Combined with Immunotherapy and Targeted Therapy in Cholangiocarcinoma

Chemotherapy Combined with Immunotherapy and Targeted Therapy in Advanced Intrahepatic Cholangiocarcinoma

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 300 (estimated)
• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cholangiocarcinoma

Interventions

Type	Name	Description
DRUG	Gemcitabine combined with cisplatin or oxaliplatin	Gemcitabine (1000 mg/m², day 1 and 8) and cisplatin (75 mg/m², day 1) or oxaliplatin (85 mg/m², day 1)
DRUG	Gemcitabine combined with cisplatin or oxaliplatin, PD-1/L1 and TKI inhibitors	Gemcitabine (1000 mg/m², day 1 and 8), cisplatin (75 mg/m²; day 1) or oxaliplatin (85 mg/m²; day 1), PD-1/L1 agents (200 mg; day 1), and TKI inhibitors (8 mg; per day)

Timeline

• Start date: 2024-09-01
• Primary completion: 2025-03-31
• Completion: 2025-05-31
• First posted: 2024-12-05
• Last updated: 2025-02-06

Locations

1 site across 1 country: China