Evaluation of Hepatic Arterial Infusion of Cisplatin and 5-FU in Biomarker Stratified HCC
NCT ID: NCT02967887
Last Updated: 2017-07-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE2
96 participants
INTERVENTIONAL
2016-11-30
2018-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Adjuvant Hepatic Arterial Infusional Chemotherapy After Curative Resection of Hepatocellular Carcinoma
NCT01088581
Phase II Study of HAIC Using Cisplatin,Leucovorin and 5-Fluorouracil
NCT02987699
Phase Ⅱ Study of HAIC of FOLFOX vs. Sorafenib in HCC Refractory to TACE
NCT03722498
Phase II Trial of Sorafenib Combined With Concurrent HAIC for Hepatocellular Carcinoma
NCT02981498
HAIC Combined With Lenvatinib and Sintilimab for Hepatocellular Carcinoma With PVTT
NCT04618367
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
cisplatin and 5-fluorouracil
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.
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)
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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 Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 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
20 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
CbsBioscience
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Si Hyun Bae, MD., PhD.
Role: PRINCIPAL_INVESTIGATOR
The Catholic University of Korea
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Korea University Ansan Hospital
Ansan, , South Korea
Sooncheonhyang University Hospital Bucheon
Bucheon-si, , South Korea
The Catholic University of Korea Bucheon ST. Mary's Hospital
Bucheon-si, , South Korea
Keimyung University Dongsan Medical Center
Daegu, , South Korea
The Catholic University of Korea Daejeon ST. Mary's Hospital
Daejeon, , South Korea
Chonnam National University Hwasun Hospital
Hwasun, , South Korea
Korea University Anam Hospital
Seoul, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Sooncheonhyang University Hospital Seoul
Seoul, , South Korea
The Catholic University of korea, Seoul ST. Mary's Hospital
Seoul, , South Korea
Ajou University Hospital
Suwon, , South Korea
The Catholic University of Korea ST. Vincent's Hospital
Suwon, , South Korea
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Yim, MD., PhD.
Role: primary
Kim, MD., PhD.
Role: primary
Lee, MD., PhD.
Role: primary
Chung, MD., PhD.
Role: primary
Song, MD., PhD.
Role: primary
Cho, MD., PhD.
Role: primary
Seo, MD., PhD.
Role: primary
Yoon, MD., PhD.
Role: primary
Jang, MD., PhD.
Role: primary
Si Hyun Bae, MD., PhD.
Role: primary
Wang, MD., PhD.
Role: primary
Cheong, MD., PhD.
Role: backup
Song, MD., PhD.
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CBS-PCT-01
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.