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

NCT06903273 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2025-03-30

No results posted yet for this study

Summary

To investigate the efficacy and tolerability of neoadjuvant tislelizumab, gemcitabine, cisplatin and S-1 (TisGCS) in patients with resectable high-risk iCCA.

Conditions

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)

Sponsors & Collaborators

  • Kaohsiung Veterans General Hospital.

    collaborator OTHER

  • Chi Mei Medical Hospital

    collaborator OTHER

  • National Cheng-Kung University Hospital

    lead OTHER

Principal Investigators

  • Chia Jui Yen, MD., PhD · Department on Oncology, National Cheng Kung University Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-01
Primary Completion
2028-07-01
Completion
2029-07-01

Countries

  • Taiwan

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06903273 on ClinicalTrials.gov