NCT06903273

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

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

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 35 (estimated)
• Sponsor: National Cheng-Kung University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

Patients with cholangiocarcinoma have limited therapeutic options and a poor prognosis. Margin-free resection is the only curative treatment to treat intrahepatic cholangiocarcinoma (iCCA). However, patients with resectable disease still suffer from high recurrence or progression. Both immune checkpoint inhibitors and chemotherapy have shed light on treating patients with iCCA. Nevertheless, the role of neoadjuvant chemo-immunotherapy has not been established in patients with resectable iCCA harboring a high risk for recurrence. The aim of the trial is to investigate the efficacy and tolerability of neoadjuvant tislelizumab, gemcitabine, cisplatin and S-1 (Tis-GCS) in patients with resectable high-risk iCCA. The primary outcome is R0 resection rate. The secondary outcome includes objective response rate, event-free survival, overall survival, protocol completion rate and adverse events. The study is an open-label, single-arm and multi-center phase II investigator-initiated trial with Simon two-stage design. Subjects with resectable iCCA harboring a high risk for recurrence or those suffer from very early recurrent disease who are eligible for a curative resection are included. A total of 35 subjects are expected with a minimal sample size of 14 when the R0 resection rate is of the lower threshold. Tis-GCS (14 days as a cycle) 3 cycles every 2 weeks will be administered and followed by surgery. Tislelizumab 200 mg fixed-dose, gemcitabine 800 mg/m2 and cisplatin 25 mg/m2 is given intravenously on day 1. S-1 (35 mg/m2) is given twice daily per oral on day 1 to 7. The study will prove the feasibility and efficacy of neoadjuvant chemo-immunotherapy in resectable high-risk iCCA. The results may provide critical fundamentals into future phase III clinical trials.

Conditions

• Cholangiocarcinoma
• Biliary Tract Cancer (BTC)

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2025-07-01
• Primary completion: 2028-07-01
• Completion: 2029-07-01
• First posted: 2025-03-30
• Last updated: 2025-03-30

Locations

1 site across 1 country: Taiwan