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RECRUITING
NCT06721286
PHASE2

Toripalimab Combined With Gemcitabine and Cisplatin (GemCis) as Preoperative Neoadjuvant Therapy for Resectable Intrahepatic Cholangiocarcinoma

Sponsor: Tianjin Medical University Cancer Institute and Hospital

View on ClinicalTrials.gov

Summary

This study was a randomized controlled trial to evaluate the efficacy and safety of toripalimab combined with GemCis (gemcitabine and cisplatin) as preoperative neoadjuvant therapy for resectable ICC at high risk of recurrence.

Official title: Toripalimab Combined With Gemcitabine and Cisplatin (GemCis) as Preoperative Neoadjuvant Therapy for Resectable Intrahepatic Cholangiocarcinoma (ICC) With High Risk of Recurrence, Phase II, Single-center, Randomized Controlled Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

70

Start Date

2024-11-12

Completion Date

2027-12-31

Last Updated

2024-12-06

Healthy Volunteers

No

Interventions

DRUG

Teripalimab

240mg intravenous injection, D1, q3w, for 9 weeks (3 cycles)

DRUG

Gemcitabine + Cisplatin

Gemcitabine 1000mg/m2 + cisplatin 25mg/m2, D1\&D8, q3w, for 9 weeks (3 cycles)

PROCEDURE

Surgery

Radical resection

Locations (1)

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, China