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

NCT06721286 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2024-12-06

No results posted yet for this study

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.

Conditions

  • Intrahepatic Cholangiocarcinoma (Icc)

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

Sponsors & Collaborators

  • Tianjin Medical University Cancer Institute and Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-12
Primary Completion
2026-12-31
Completion
2027-12-31

Countries

  • China

Study Locations

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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 NCT06721286 on ClinicalTrials.gov