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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02967887
Other study ID # CBS-PCT-01
Secondary ID
Status Recruiting
Phase Phase 2
First received November 10, 2016
Last updated July 13, 2017
Start date November 2016
Est. completion date December 2018

Study information

Verified date July 2017
Source CbsBioscience
Contact Jin Young Park
Phone 82-2-336-0855
Email jonnypark@cbsbio.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 96
Est. completion date December 2018
Est. primary completion date October 2018
Accepts healthy volunteers No
Gender All
Age group 20 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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)

Locations

Country Name City State
Korea, Republic of Korea University Ansan Hospital Ansan
Korea, Republic of Sooncheonhyang University Hospital Bucheon Bucheon
Korea, Republic of The Catholic University of Korea Bucheon ST. Mary's Hospital Bucheon
Korea, Republic of Keimyung University Dongsan Medical Center Daegu
Korea, Republic of The Catholic University of Korea Daejeon ST. Mary's Hospital Daejeon
Korea, Republic of Chonnam National University Hwasun Hospital Hwasun
Korea, Republic of Korea University Anam Hospital Seoul
Korea, Republic of Seoul National University Hospital Seoul
Korea, Republic of Sooncheonhyang University Hospital Seoul Seoul
Korea, Republic of The Catholic University of korea, Seoul ST. Mary's Hospital Seoul
Korea, Republic of Ajou University Hospital Suwon
Korea, Republic of The Catholic University of Korea ST. Vincent's Hospital Suwon

Sponsors (1)

Lead Sponsor Collaborator
CbsBioscience

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Other Exploratory endpoint: Diagnostic performance of biomarkers Patients will be categorized according to the result of biomarker expression and then AUC value of ROC curve analysis will be evaluated as an exploratory endpoint to assess predictive performance of biomarkers for therapeutic response of drugs. Through study completion, an average of 3 months
Primary Objective tumor response Objective tumor response according to Modified Response Evaluation Criteria in Solid Tumors (mRECIST) assessed by radiological review Approximately 6 months
Secondary Time-to-Progression Approximately 24 months
Secondary Progression-free-survival Approximately 24 months
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