Inetetamab Plus Chemotherapy ± PD-1/PD-L1 in HER2+ Advanced Biliary Cancer

PHASE4Not yet recruitingINTERVENTIONAL
Enrollment

35

Participants

Timeline

Start Date

February 28, 2025

Primary Completion Date

December 31, 2026

Study Completion Date

December 31, 2027

Conditions
Metastatic Biliary Tract CancerHER2 Positive
Interventions
DRUG

Inetetamab + Gemcitabine + Cisplatin ± PD-1/PD-L1 inhibitor

A 21-day cycle is used, with the initial dose of inetuximab at 8 mg/kg (IV), followed by 6 mg/kg (IV) on Day 1 of each subsequent cycle. Gemcitabine (1000 mg/m²) + cisplatin (25 mg/m²) are administered in combination on Day 1 and Day 8 of each cycle. The appropriate PD-1/PD-L1 inhibitor will be selected by the investigator based on the patient's specific condition, and its administration will strictly follow the dosing instructions provided in the relevant drug's package insert.

All Listed Sponsors
lead

Eastern Hepatobiliary Surgery Hospital

OTHER