Hepatocellular Carcinoma Non-ResectablePhase 2SHINENCT02967887
Evaluation of Hepatic Arterial Infusion of Cisplatin and 5-FU in Biomarker Stratified HCC
A Phase 2 study testing cisplatin and 5-fluorouracil in people with Hepatocellular Carcinoma Non-Resectable, run by CbsBioscience at 12 sites in South Korea.
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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Hepatocellular Carcinoma Non-Resectable
- What is being tested?
- cisplatin and 5-fluorouracil
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 12 sitesSouth Korea
- Study dates
- Nov 2016to Dec 2018
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 12Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
South Korea12 sites, 12 recruiting
- Not yet recruiting
Korea University Ansan Hospital
Ansan
Yim, MD., PhD.
- Not yet recruiting
Sooncheonhyang University Hospital Bucheon
Bucheon-si
Kim, MD., PhD.
- Not yet recruiting
The Catholic University of Korea Bucheon ST. Mary's Hospital
Bucheon-si
Lee, MD., PhD.
- Not yet recruiting
Keimyung University Dongsan Medical Center
Daegu
Chung, MD., PhD.
- Not yet recruiting
The Catholic University of Korea Daejeon ST. Mary's Hospital
Daejeon
Song, MD., PhD.
- Not yet recruiting
Chonnam National University Hwasun Hospital
Hwasun
Cho, MD., PhD.
- Not yet recruiting
Korea University Anam Hospital
Seoul
Seo, MD., PhD.
- Not yet recruiting
Seoul National University Hospital
Seoul
Yoon, MD., PhD.
- Recruiting
Sooncheonhyang University Hospital Seoul
Seoul
Jang, MD., PhD.
- Recruiting
The Catholic University of korea, Seoul ST. Mary's Hospital
Seoul
Si Hyun Bae, MD., PhD.
- Recruiting
Ajou University Hospital
Suwon
Wang, MD., PhD.
Cheong, MD., PhD.
- Not yet recruiting
The Catholic University of Korea ST. Vincent's Hospital
Suwon
Song, MD., PhD.
About this study
Official title: 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
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.
Read the detailed 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.
- Conditions
- Hepatocellular Carcinoma Non-Resectable
- Being tested
- cisplatin and 5-fluorouracil
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cisplatin and 5-fluorouracilDrug
Also called CBD-01 and CBD-02
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)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: cisplatin and 5-fluorouracil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective tumor response
Objective tumor response according to Modified Response Evaluation Criteria in Solid Tumors (mRECIST) assessed by radiological review
Measured: Approximately 6 months
Secondary outcomes (2)
Time-to-Progression
Measured: Approximately 24 months
Progression-free-survival
Measured: Approximately 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2016 (estimated)
- Study startNov 2016
- Primary completionOct 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular Carcinoma Non-ResectableStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CbsBioscience
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Si Hyun Bae, MD., PhD., Principal investigator, The Catholic University of Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02967887
- Sponsor's protocol ID
- CBS-PCT-01
- Acronym
- SHINE
- Status last verified
- Jul 2017
- First submitted
- 10 Nov 2016
- Last updated
- 17 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02967887
- Acronym / sponsor ID
- SHINE / CBS-PCT-01
- Conditions
- Hepatocellular Carcinoma Non-Resectable
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- CbsBioscienceIndustry (pharma, biotech, devices)
- Study start
- Nov 2016
- Primary completion
- Oct 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 18 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cisplatin and 5-fluorouracil | Experimental | Drug: cisplatin and 5-fluorouracilEnrolled 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. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cisplatin and 5-fluorouracilAlso: CBD-01 and CBD-02Hepatic 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) | Drug | cisplatin and 5-fluorouracil |
Primary outcome
Objective tumor response
Time frame: Approximately 6 months
Objective tumor response according to Modified Response Evaluation Criteria in Solid Tumors (mRECIST) assessed by radiological review
2 secondary outcomes
Time-to-Progression
Time frame: Approximately 24 months
Progression-free-survival
Time frame: Approximately 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2017.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Si Hyun Bae, MD., PhD. principal investigator
The Catholic University of Korea
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing cisplatin and 5-fluorouracil in people with Hepatocellular Carcinoma Non-Resectable, run by CbsBioscience at 12 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jin Young Park (82-2-336-0855, jonnypark@cbsbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective tumor response (time frame: Approximately 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2017.