Clinical Trials List
2014-03-01 - 2019-01-31
Phase III
Terminated16
Study ended1
A phase III, placebo-controlled, multi-center, randomized, double-blind trial to evaluate the efficacy and safety of K-333 (peretinoin) in patients with complete cure of hepatocellular carcinoma in Asia
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Sponsor
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Trial scale
Multi-Regional Multi-Center
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Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
- Ming-Chih Ho Division of General Surgery
- REY-HENG HU Division of General Surgery
- Yao-Ming Wu Division of General Surgery
- KAI-WEN HUANG Division of General Surgery
- JA-DER LIANG Digestive System Department
The Actual Total Number of Participants Enrolled
0 Terminated
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Terminated
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Terminated
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Terminated
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Terminated
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Terminated
The Actual Total Number of Participants Enrolled
0 Terminated
The Actual Total Number of Participants Enrolled
0 Terminated
The Actual Total Number of Participants Enrolled
29 Study ended
The Actual Total Number of Participants Enrolled
0 Terminated
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
Dosage
Endpoints
Efficacy: Recurrence-free survival
(Time to recurrence of HCC or death, regardless of cause)
Incidence of adverse events and incidence of adverse drug reactions
Secondary endpoints
Efficacy: Disease-free survival
(Time to recurrence of HCC, occurrence of secondary cancer or occurrence of death
from any cause)
Time to recurrence
(Time to the recurrence of HCC)
Safety: Vital sign, body weight, laboratory test (hematology, blood chemistry, urinalysis), bone density test, endoscopy, electrocardiography
10.1.3 Analysis of exploratory variables
QOL: Evaluated by the patient himself or herself with the use of the EQ-5D-3L questionnaire Predictive marker protein
Inclution Criteria
(1) Patients with HCC who meet the following criteria before radical therapy
1) Patients diagnosed as having typical HCC on dynamic CT, CTHA/CTAP, or dynamic MRI
(nodule visualized as a high signal intensity area in the arterial phase and as a relatively low signal intensity area in the portal or equilibrium phases) performed within 8 weeks (56 days) before radical therapy
2) Patients with the primary occurrence HCC or the first recurrence of HCC (having, in the case of a first recurrence of HCC, an interval of at least one year after treatment of the primary occurrence of HCC; i.e, the treatment end date for the primary occurrence of HCC is at least one year prior to the date of first recurrence, having as its starting point the treatment start date for radical therapy)
3) Patients with the HCC related to HBV or HCV
(2) Patients who received one of the following treatments. The treatment duration (from the start to the end of the treatment) should be within 4 weeks (28 days) for each of the radical therapies.
1) Local ablation
Patients who have undergone radical therapy of HCC by radiofrequency ablation (RFA)
(Otherwise, percutaneous ethanol injection (PEI) or percutaneous microwave coagulation
therapy (PMC) in combination with RFA are allowed.).
2) Surgical resection
Patients who have undergone liver resection.
(3) Patients showing a complete cure, as confirmed by one of the following methods
1) Local ablation
The dynamic CT images taken from 8 weeks (56 days) to 12 weeks (84 days) after the end of the treatment show a non-stained low-concentration area overlapping the tumor image observed before complete cure. There are no other findings suggestive of recurrence. The investigator of the study center has confirmed complete cure, and the independent review committee has also confirmed complete cure on the same image.
2) Surgical resection
The dynamic CT images taken from 8 weeks (56 days) to 12 weeks (84 days) after the end of the treatment show no findings suggestive of recurrence or remnant. The investigator or the subinvestigator of the study center has confirmed complete cure, and the independent review committee has also confirmed complete cure on the same image.
(4) Patients who are able to begin treatment with the study drug within 8 weeks (56 days) after dynamic CT to confirm complete cure
(5) Patients confirmed of satisfying the following conditions based on the screening performed at subject registration
1) Positive for HBs antigen or HCV-RNA
2) Grade A on Child-Pugh classification1,2,3)
3) Platelet count greater than or equal to 50 000/µL
(6) Patients with ECOG Performance Status score of 0 to 1
(7) Patients of the age of 20 years or older at the time of informed consent
(8) Patients who can read the informed consent document by themselves, and also can understand and consent for the content before enrolling the study.
Exclusion Criteria
(1) Patients positive both for HBs antigen and HCV-RNA
(2) Patients with the HCC related to hepatitis virus other than HBV and HCV, non viral hepatitis; alcoholic liver disease, nonalcoholic steatohepatitis (NASH) and others.
(3) Patients showing vascular invasion of HCC on imaging diagnosis (as evaluated by study center and the independent review committee)
(4) Patients who have also undergone transcatheter arterial embolization or chemoembolization (TAE/TACE), transcatheter arterial infusion (TAI),or chemolipiodolization in combination with the radical therapy
* Although the use of lipiodol for arterial embolization is not allowed, the use of lipiodol for support of radical therapy is permitted.
(5) Patients who will receive antiviral therapy such as interferon (except nucleic acid analog) for treatment of HBV or HCV during the study period
(6) Patients who have received any other investigational drugs, anticancer drugs, or interferons after radical therapy
(7) Patients who have received peretinoin
(8)Patients who have uncontrolled hypertension with adequate medication, defined as systolic blood pressure higher or equal to 160 mmHg or diastolic blood pressure higher or equal to 100 mmHg at registration
(9) Patients who have a history of allergy to CT contrast media, and whose participation in this study is judged to be inappropriate by the investigator or the subinvestigator
(10) Patients with a history of total gastrectomy
(11) Patients with a history of cardiac arrest
(12) Patients with any of the following laboratory test or complications
1) Creatinine ≥ 1.5mg/dL
2) Urinary albumin (corrected for creatinine) ≥ 1000 mg/g・Cre
3) CTC-AE grade 3 cardiac disease
4) Diabetes mellitus with HbA1c ≥ 7.4% (NGSP standard) with insulin treatment
5) Autoimmune disease or asthma with oral steroid treatment
6) Positive for human immunodeficiency virus (HIV)
(13) Patient has a concurrent active malignancy other than Hepatoma. A patient with previous history of malignancy is eligible, provided that has been disease free for > 5 years. (exception of patients who were adequately treated with resection for carcinoma in situ or patients with endoscopically resection for carcinoma in situ
(14) Patients who are pregnant, who have a possibility of being pregnant or who desire to become pregnant during the study period
(15) Lactating women
(16) Patients who have a history of allergy to retinoid-related substances (vitamin A, etc.)
(17) Patients who participated in other clinical trial within past 6 months
(18) Patients who are deemed inappropriate to participate in the study by the investigator or the subinvestigator judgment
The Estimated Number of Participants
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Taiwan
200 participants
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Global
600 participants
