The Identification of the Safety and Efficacy of Tadalafil for the Suppression of Recurrence of Hepatocellular Carcinoma
- Conditions
- Neoplasms
- Registration Number
- KCT0003946
- Lead Sponsor
- Seoul National University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Male
- Target Recruitment
- 24
1) Men over 19 years old
2) Those who voluntarily agree to participate in this trial and are signed by the subject or legal representative
3) Those who were initially diagnosed with HCC for radical resection or local removal
4) HCC not associated with viruses or those with HBV-HCC or HCV-HCC as defined below
(1) HBV-HCC: Those who meet one of the following criteria:
- There is evidence that HBV infection has been resolved (detection of HBV surface antibodies, detection of HBV core antibodies, non-detection of HBV DNA, and detection of HBV surface antigens)
- Chronic HBV infection with evidence of HBV surface antigen detection or HBV DNA detection
(2) HCV-HCC: Those who meet one of the following criteria:
- HCV infection is resolved (evidence of antibody detection)
- Chronic HCV infection (evidence of detection of HCV RNA)
5) The characteristics of the tumor, as defined below, are those who undergo hepatectomy or local removal or ethanol injection
(1) Those who undergo liver resection and have one or more of the following tumor characteristics:
- There is no evidence of up to 3 tumors (minimum diameter of one of them> 5 cm) and invasion of large vessels
- Up to three tumors, none of which have a diameter of more than 5 cm, are included in the pathologic report of resected specimens in the presence of microvascular involvement (defined as the presence of hepatic central vein, portal vein or encapsulated large intestinal tumor embolism) or borderless / undifferentiated HCC G3-G4) confirmed
Note: Patients with evidence of macrovascular involvement in the pathology report may only be enrolled if preoperative surveillance confirms absence of macrovascular invasion prior to resection.
- More than 3 tumors, none of them exceeding 5 cm in diameter, no evidence of macrovascular invasion
(2) Those who have undergone topical removal [RFA or ethanol injection (PEIT)] and have at least one of the following characteristics:
- There is only one tumor of size> 3 cm, = 5 cm
- Multiple tumors (up to 4), none of them exceeding 5 cm in diameter
6) A complete resection recorded in the pathology report [a surgically induced disease-free condition with no margins in the resected specimen (R0)] or a radiologically recorded complete response after local removal (non-staining, (Overlapping with the acquired tumor image)
7) Computed tomography / magnetic resonance imaging (CT / MRI) for abdominal / pelvic / other suspected or unknown lesions), which confirms a disease-free condition within the screening period after complete tumor removal or topical removal after surgical resection. If a disease-free condition is confirmed after bone scan (if recommended), lymph nodes with a shortening of less than 10 mm at baseline time are regarded as not pathological and can be registered
8) Child-Pugh Score is 5 or 6 points
9) Eastern Cooperative Oncology Group (ECOG) performance status is 0 or 1
10) Those whose life expectancy is more than 6 months
11) Laboratory tests of screening must meet the following criteria:
- WBC =2,000 / µL (steady state, no growth factors within 4 weeks before dosing)
- ANC =1,500 / µL (steady state, no growth factors within 4 weeks before administration of test drug)
- Hemoglobin =8.5g / dL (may be transfused to meet this requirement)
- Platelet count =60 × 10 3 / µL (transfusion to achieve this value is not allowed)
(2) Liver function test
- Serum albumin> 2.8 g / dL (no transfusion to achieve this value)
- Total serum bilirubin <3
1) Those who have the following target diseases
(1) Known fiber lamellae HCC, sarcomatous HCC or mixed cholangiocarcinoma and HCC
(2) If HCC had previously relapsed
(3) If there is evidence of tumor metastasis or coexistence of malignant disease
(4) A person with evidence of a large vessel invasion
(5) Those who receive liver transplants or are listed on the waiting list for liver transplants
2) Those who have the following medical condition
(1) Those who have the following coinfection activities
- Both hepatitis B and hepatitis C infection (detectable HBV surface antigen (HBsAg) or HBV DNA and HCV RNA evidence)
(2) Human immunodeficiency virus (HIV) test positive
(3) It is possible that the tester's judgment may increase the risk associated with participating in the study or administering the test drug, or may impair the ability of the subject to receive therapy on the trial protocol, or cause serious disturbance in the interpretation of the test results Those with uncontrolled illness
(4) A person who has an active, immune disease, or is known or suspected
(Patients with type 1 diabetes, hypothyroidism that requires hormone replacement therapy only, hypothyroidism that does not require systemic therapy (eg, vitiligo, psoriasis, hair loss), or a condition in which no recurrence is expected without external stimulants Registration is allowed)
(5) Patients who require systemic therapy using corticosteroids (> 10 mg / day prednisone equivalent dose) or other immunosuppressive agents within 14 days before initiation of the trial (However, prednisone> 10 mg / day inhaled dose or topical steroids and adrenal substitute steroids are permitted in the absence of active autoimmune disease)
(6) If there is a history of malignancy during the last 5 years before participating in the clinical trial (However, malignant tumors with poor prognosis, such as carcinoma in situ, except carcinoma in situ, are determined by the researcher)
(7) Persons with cardiac disease whose sexual activity is not recommended
(8) The following patients with cardiovascular disease
- Patients with myocardial infarction within the last 90 days
- Patients with angina that occurred during unstable angina or sexual intercourse
- Patients with a New York Heart Association Class 2 or greater heart failure during the last 6 months
- Patients with uncontrolled arrhythmias, hypotension (<90 / 50mmHg), or uncontrolled hypertension (> 170 / 100mmHg)
- Patients who had a stroke within the last 6 months
(9) Known genetic degenerative retinal disease including pigmentary retinitis
(10) Patients with loss of visual acuity in one eye due to non-arteritic anterior ischemic optic neuropathy (NAION), regardless of previous PDE5 inhibitors
(11) Hemorrhagic or active peptic ulcer patient
(12) Patients whose penis is anatomically malformed (angulation, Peyronie's disease), those with conditions that will be a predisposition to penile ankylosis
3) Those who have received the following therapy with previous therapy and combination therapy
(1) Those who have received prior HCC therapy before or after resection or removal, such as topical site therapy
(2) Those who are receiving IFN-based therapy or who are scheduled to undergo IFN-based therapy during the trial
(3) A person who has undergone herbal remedies (eg, herbal supplements or herbal medicines) performed within 2 weeks prior to the initiation of the test therapy for the purpose of general health-aid purposes or for t
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Toxicities of grade 3 or higher
- Secondary Outcome Measures
Name Time Method Time to progression (TTP);Recurrence-free survival (RFS);Overall survival (OS)