Overview

A Single-arm Study of Gemcitabine, Cisplatin, and Nab-Paclitaxel as Neoadjuvant Therapy for Resectable Oncologically High-Risk IHCC in Korea

Status:
Not yet recruiting

Trial end date:
2022-03-01

Target enrollment:

Participant gender:

Summary

1. Phase of Development: II 2. Patient Population: Resectable Oncologically High-Risk Intrahepatic Cholangiocarcinoma 3. Estimated Number of Patients: 34 patients 4. Primary Objective: To assess the resetability of neoadjuvant chemotherapy including gemcitabine, cisplatin, and nab-paclitaxel for resectable oncologically high-risk intrahepatic cholangiocarcinoma that is treated with surgical resection. Thus, the primary aim is to increase R0 resection rate via completion of all treatment 5. Secondary Objectives: 1) To assess the radiological response rate according to Response Evaluation Criteria in Solid Tumors (RECIST) 2) To determine the overall resection rate 3) To determine recurrence-free survival (RFS) 4) To identify patients' overall survival (OS) rate. 5) Saftey and tolerability 6.Exploratory Endpoint : QoL analysis via EORTC QLO C-30

Phase:

Phase 2

Details

Lead Sponsor:

Samsung Medical Center

Treatments:

Gemcitabine