NCT02967887

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
96

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Nov 2016

Geographic Reach
1 country

12 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2016

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

November 10, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 18, 2016

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

July 17, 2017

Status Verified

July 1, 2017

Enrollment Period

1.9 years

First QC Date

November 10, 2016

Last Update Submit

July 13, 2017

Conditions

Hepatocellular Carcinoma Non-Resectable

Outcome Measures

Primary Outcomes (1)

  • Objective tumor response

    Objective tumor response according to Modified Response Evaluation Criteria in Solid Tumors (mRECIST) assessed by radiological review

    Approximately 6 months

Secondary Outcomes (2)

  • Time-to-Progression

    Approximately 24 months

  • Progression-free-survival

    Approximately 24 months

Other Outcomes (1)

  • Exploratory endpoint: Diagnostic performance of biomarkers

    Through study completion, an average of 3 months

Study Arms (1)

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.

Drug: cisplatin and 5-fluorouracil

Interventions

cisplatin and 5-fluorouracilDRUG

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)

Also known as: CBD-01 and CBD-02
cisplatin and 5-fluorouracil

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Korea University Ansan Hospital

Ansan, South Korea

NOT YET RECRUITING

Sooncheonhyang University Hospital Bucheon

Bucheon-si, South Korea

NOT YET RECRUITING

The Catholic University of Korea Bucheon ST. Mary's Hospital

Bucheon-si, South Korea

NOT YET RECRUITING

Keimyung University Dongsan Medical Center

Daegu, South Korea

NOT YET RECRUITING

The Catholic University of Korea Daejeon ST. Mary's Hospital

Daejeon, South Korea

NOT YET RECRUITING

Chonnam National University Hwasun Hospital

Hwasun, South Korea

NOT YET RECRUITING

Korea University Anam Hospital

Seoul, South Korea

NOT YET RECRUITING

Seoul National University Hospital

Seoul, South Korea

NOT YET RECRUITING

Sooncheonhyang University Hospital Seoul

Seoul, South Korea

RECRUITING

The Catholic University of korea, Seoul ST. Mary's Hospital

Seoul, South Korea

RECRUITING

Ajou University Hospital

Suwon, South Korea

RECRUITING

The Catholic University of Korea ST. Vincent's Hospital

Suwon, South Korea

NOT YET RECRUITING

MeSH Terms

Interventions

CisplatinFluorouracil

Intervention Hierarchy (Ancestors)

Chlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum CompoundsUracilPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Si Hyun Bae, MD., PhD.

    The Catholic University of Korea

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jin Young Park

CONTACT

82-2-336-0855jonnypark@cbsbio.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 10, 2016

First Posted

November 18, 2016

Study Start

November 1, 2016

Primary Completion

October 1, 2018

Study Completion

December 1, 2018

Last Updated

July 17, 2017

Record last verified: 2017-07

Locations

KR(12)