Neoadjuvant Tislelizumab, Gemcitabine, Cisplatin and S-1 for Resectable High-risk Cholangiocarcinoma

PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

35

Participants

Timeline

Start Date

July 1, 2025

Primary Completion Date

July 1, 2028

Study Completion Date

July 1, 2029

Conditions
CholangiocarcinomaBiliary Tract Cancer (BTC)
Interventions
DRUG

Tislelizumab

"Tislelizumab plus chemotherapy (14 days as one cycle) 3 cycles every 2 weeks as neoadjuvant therapy and followed by a curative surgery.~Tislelizumab 200 mg fixed-dose IVD on day 1. Gemcitabine 800 mg/m2 on day 1 with a fixed-infusion rate of 80 mins. Cisplatin 25 mg/m2 on day 1. S-1 70 mg/m2 daily as a BID dosing per oral on day 1 to 7. (daily total dose determined by body surface area (BSA): \<1.25 m2, 80 mg; 1.25-1.50 m2, 100 mg; ≥1.50 m2, 120 mg)"

Trial Locations (1)

70403

National Cheng Kung University Hospital, Tainan City

All Listed Sponsors
collaborator

Kaohsiung Veterans General Hospital.

OTHER

collaborator

Chi Mei Medical Hospital

OTHER

lead

National Cheng-Kung University Hospital

OTHER