Trial | NCT02967887  Report issue

Title

Evaluation of Hepatic Arterial Infusion of Cisplatin and 5-FU in Biomarker Stratified HCC
Single-arm, Prospective, Multicenter Clinical Trial to Assess the Efficacy and the Safety of Combination Therapy of Hepatic Arterial Infusion of Cisplatin and 5-FU in Advanced Hepatocellular Carcinoma With Low Expression of HMGB2 Biomarker

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    96
This study is to assess the efficacy and the safety of hepatic arterial infusion of cisplatin and 5-fluorouracil (HAIC) in advanced HCC patients stratified by biomarker expression predicting therapeutic response.
Hepatic arterial infusion chemotherapy (HAIC) with cisplatin and 5-fluorouracil has been used in advanced HCC. However, cisplatin or 5-fluorouracil acts on cells without tumor selectivity. Therefore, to improve the tumor selectivity and effectiveness of HAIC, molecular subtyping-based stratification strategies should be considered. In this study, patients who have progressed or intolerance to sorafenib with non-metastatic HCC in TNM stage III-IVA and ECOG PS 0 or 1, Child-Pugh class A will be enrolled. 96 patients with pre-treatment tumor biopsy will receive Cisplatin (60mg/m2 for 2h on day 2) and 5-fluorouracil (500mg/m2 for 5h on days 1-3) through implanted port system. This treatment will be repeated every 4 weeks, up to 6 times. The primary objective is to determine overall response rate, where benefit is defined as complete or partial response according to mRECIST V1.1. Secondary endpoints include time to progression, progression free survival. The biopsy tissue will be subjected to real time reverse transcriptase polymerase chain reaction for quantification of gene expression levels. Patients will be categorized into two groups according to gene expression results, and then AUC value of ROC curve analysis will be evaluated as an exploratory endpoint to assess predictive performance of biomarker for therapeutic response of HAIC.
Study Started
Nov 30
2016
Primary Completion
Oct 31
2018
Anticipated
Study Completion
Dec 31
2018
Anticipated
Last Update
Jul 17
2017

Drug cisplatin and 5-fluorouracil

Hepatic arterial infusion of Cisplatin (60mg/m2 for 2h on day 2) and 5-fluorouracil (500mg/m2 for 5h on days 1-3) through implanted port system (chemoport)

  • Other names: CBD-01 and CBD-02

cisplatin and 5-fluorouracil Experimental

Enrolled patients with pre-treatment tumor biopsy will receive Cisplatin (60mg/m2 for 2h on day 2) and 5-fluorouracil (500mg/m2 for 5h on days 1-3) through implanted port system. This treatment will be repeated every 4 weeks, up to 6 times.

Criteria 

Inclusion Criteria:

over 20 years old
Patients with advanced hepatocellular carcinoma who have progressed or intolerance to Sorafenib
Patients with advanced hepatocellular carcinoma who cannot be treated with surgery, transplantation, RFA, or TACE.
TNM stage III/IV (including intrahepatic single or multiple tumors without extrahepatic metastasis regardless of lymph node metastasis)
ECOG performance status of 0 or 1
Liver function status of Child-Pugh Class A or B
more than 3 months of life expectancy
serum creatinine <1.5 mg/dL
aminotransferase <5 times the upper limit of normal
absolute neutrophil count >1,500 cells/lL
platelet count >75,000/lL
hemoglobin >10 g/dL

Exclusion Criteria:

patients with extrahepatic tumors
Patients requiring combined treatment with chemotherapy, radiotherapy, TACE, RFA, or others
Patients in any severe and/or uncontrolled medical conditions
patients with history of allergic response to CT contrast media
patients who participated as subjects in other interventional clinical studies (as of the date of visit) within 60 days before drug administration
Any person deemed inappropriate by reason of the investigator for other reasons
No Results Posted