Efficacy and Safety of Sorafenib in Previously Treated Advanced Hepatocellular Carcinoma: SOPT Study

Study Overview
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Brief Summary
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To investigate the efficacy and safety of sorafenib administered as later lines of treatment in patients with advanced HCC.

Detailed Description
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Sorafenib (Soranib Tablet) will be administered orally at a dose of 600mg daily without food for patients who have been treated with prior systemic therapy for advanced HCC. The study drug is continued until disease progression, unacceptable toxicity, withdrawal of consent, or study closure. Response to sorafenib should be assessed at least every 8 weeks (± 7 days) by either CT scan or MRI. After the treatment phase, subjects will undergo follow up for survival and the use of other anticancer treatments and/or therapies every 12 weeks (± 7 days) from the last dose and the survival follow up will be performed for at least 12 months after the enrollment of the last subject.

Official Title
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Efficacy and Safety of Sorafenib in Previously Treated Advanced Hepatocellular Carcinoma: SOPT Study

Conditions
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Advanced Hepatocellular Carcinoma

Intervention / Treatment
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* Drug: Sorafenib


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed written informed consent Age of 20 or more Histological or clinical diagnosis of HCC based on the guidelines of the Korean Liver Cancer Association-National Cancer Center Locally advanced unresectable or metastatic disease not amenable to curative surgical and/or locoregional therapies Intolerant to or progressed on at least 1 prior systemic treatment for HCC Having at least one measurable target lesion (per RECIST v1.1) - Patients who received prior local therapy (e.g., radiofrequency ablation, transarterial chemoembolization, transarterial embolization, radiation therapy etc.) are eligible provided that other target lesion(s) have not been previously treated with local therapy or the target lesion(s) within the field of local therapy have subsequently progressed in accordance with RECIST 1.1. Child-Pugh class A or B7 Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1 Life expectancy of at least 16 weeks Adequate hematologic and hepatic function (should be obtained within 14 days prior to initiation of study treatment): Women of childbearing potential and men must agree to use highly efficient contraception since signing of the IC form until at least 5 months (women) and 7 months (men) after the last study drug administration. Exclusion Criteria: Fibrolamellar carcinoma or sarcomatoid carcinoma Having active brain metastasis or leptomeningeal metastasis Moderate to severe or intractable ascites Presence of hepatic encephalopathy Presence of active bacterial infection Uncontrolled severe medical comorbidity Other malignant disease (a history of treated malignancy -other than HCC- is allowable if the patient's malignancy has been in complete remission, off chemotherapy and without additional surgical intervention, during the preceding two years) Other patients judged by the investigator or sub-investigator to be inappropriate as subjects of this study

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sorafenib<br>Sorafenib will be administered orally at a dose of 600mg (3 tablets; 400mg orally in the morning and 200mg orally in the evening about 12 hours apart or 200mg orally in the morning and 400mg orally in the evening about 12 hours apart) daily without food (at least 1 hour before or 2 hours after a meal). | Drug: Sorafenib<br>* Subjects will receive sorafenib 600mg orally daily. When dose reduction is necessary during the treatment of HCC, the sorafenib dose should be reduced to 400mg once daily. Escalation of sorafenib from a daily dose of 600mg to 800mg (400mg twice daily) is allowed if the subject who is tolerating the 600mg sorafenib dose level well. Treatment will continue until progression, unacceptable toxicity, withdrawal of consent, or study end, whichever occurs first.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival (PFS) | Progression-free survival (PFS) is defined as the time from the date of treatment initiation to the date of the first observation of progressive disease (PD) by independent radiologic review according to RECIST criteria (version 1.1) or death from any cause. | Until 12 months after the last patient was enrolled | 
| Safety (Adverse events) | Incidence of adverse events will be evaluated. | Until 12 months after the last patient was enrolled | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival (OS) | OS is defined as the time from the date of treatment initiation to the date of death. | Until 12 months after the last patient was enrolled | 
| Time to progression (TTP) | TTP is defined as the time from the date of treatment initiation to the date of the first observation of PD by independent radiologic review according to RECIST criteria (version 1.1). | Until 12 months after the last patient was enrolled | 
| Objective response rate (ORR) | ORR is defined as the proportion of enrolled subjects whose best overall response is a complete response (CR), or partial response (PR) using the RECIST criteria (version 1.1). | Until 12 months after the last patient was enrolled | 
| Disease control rate (DCR) | DCR is defined as the proportion of enrolled subjects whose best overall response is a CR or PR or stable disease (SD) using the RECIST criteria (version 1.1). | Until 12 months after the last patient was enrolled | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HCC, Sorafenib