Envafolimab With Chemotherapy and Simvastatin in Advanced Biliary Tract Cancer

PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

62

Participants

Timeline

Start Date

June 30, 2025

Primary Completion Date

December 31, 2026

Study Completion Date

June 30, 2028

Conditions
Biliary Tract CancerAdvanced Cancer
Interventions
DRUG

Envafolimab + Gemcitabine + Cisplatin + Simvastatin

"Envafolimab (generic name):~Dose: 300 mg, intravenous (IV) infusion. Schedule: Day 1 of each 21-day cycle (induction phase); every 28 days (maintenance phase).~Role: PD-L1 inhibitor immunotherapy.~Gemcitabine (generic name):~Dose: 1,000 mg/m², IV infusion. Schedule: Days 1 and 8 of each 21-day cycle (induction phase only).~Cisplatin (generic name):~Dose: 25 mg/m², IV infusion. Schedule: Days 1 and 8 of each 21-day cycle (induction phase only).~Simvastatin (generic name):~Dose: 40 mg, oral tablet. Schedule: Daily (continuously through induction and maintenance phases). Investigational Role: Potential immunomodulator and chemosensitizer in biliary tract cancer.~Treatment Phases:~Induction Phase (Cycles 1-8, 21-day cycles): All four drugs administered. Maintenance Phase (Post-Cycle 8): Envafolimab + Simvastatin only (28-day cycles)."

All Listed Sponsors
lead

Tongji Hospital

OTHER