Chemotherapy Combined with Immunotherapy and Targeted Therapy in Cholangiocarcinoma

Zhejiang University

Status: Enrolling

Conditions: Cholangiocarcinoma

Treatments: Drug: Gemcitabine combined with cisplatin or oxaliplatin, PD-1/L1 and TKI inhibitors; Drug: Gemcitabine combined with cisplatin or oxaliplatin

Study type: Observational

Funder types: Other

Identifiers

NCT06718257

2024-1058

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

300 participants in 2 patient groups

Control group

Description:

Patients initially received GP/GEMOX regimen.

Treatment:

Drug: Gemcitabine combined with cisplatin or oxaliplatin

Experimental group

Description:

Patients initially received GP/GEMOX combined with PD-1/L1 and TKI inhibitors regimen.

Treatment:

Drug: Gemcitabine combined with cisplatin or oxaliplatin, PD-1/L1 and TKI inhibitors