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

Primary Purpose

Advanced Hepatocellular Carcinoma

Status

Enrolling by invitation

Phase

Phase 2

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Sorafenib

About this trial

This is an interventional treatment trial for Advanced Hepatocellular Carcinoma focused on measuring HCC, Sorafenib

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

National Cancer Center, Korea

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Sorafenib

Arm Description

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).

Outcomes

Primary Outcome Measures

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.

Safety (Adverse events)

Incidence of adverse events will be evaluated.

Secondary Outcome Measures

Overall survival (OS)

OS is defined as the time from the date of treatment initiation to the date of death.

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).

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).

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).

Full Information

NCT ID

NCT05117957

First Posted

October 21, 2021

Last Updated

October 19, 2022

Sponsor

Bo Hyun Kim

1. Study Identification

Unique Protocol Identification Number

NCT05117957

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2022

Overall Recruitment Status

Enrolling by invitation

Study Start Date

February 8, 2022 (Actual)

Primary Completion Date

October 31, 2024 (Anticipated)

Study Completion Date

December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Bo Hyun Kim

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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

Detailed Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Advanced Hepatocellular Carcinoma

Keywords

HCC, Sorafenib

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Sorafenib

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Sorafenib

Intervention Description

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.

Primary Outcome Measure Information:

Title

Progression-free survival (PFS)

Description

Time Frame

Until 12 months after the last patient was enrolled

Title

Safety (Adverse events)

Description

Incidence of adverse events will be evaluated.

Time Frame

Until 12 months after the last patient was enrolled

Secondary Outcome Measure Information:

Title

Overall survival (OS)

Description

OS is defined as the time from the date of treatment initiation to the date of death.

Time Frame

Until 12 months after the last patient was enrolled

Title

Time to progression (TTP)

Description

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).

Time Frame

Until 12 months after the last patient was enrolled

Title

Objective response rate (ORR)

Description

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).

Time Frame

Until 12 months after the last patient was enrolled

Title

Disease control rate (DCR)

Description

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).

Time Frame

Until 12 months after the last patient was enrolled

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bo Hyun Kim, M.D.

Organizational Affiliation

National Cancer Center, South Korea

Official's Role

Principal Investigator

Facility Information:

Facility Name

National Cancer Center, Korea

City

Seoul

Country

Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

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

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