Clinical trial NCT05117957: 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
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE2
Conditions: Advanced Hepatocellular Carcinoma
Keywords: HCC
Sorafenib
Lead sponsor: National Cancer Center, Korea
Sponsor class: OTHER_GOV
First posted: 2021-11-11
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. Signed written informed consent
2. Age of 20 or more
3. Histological or clinical diagnosis of HCC based on the guidelines of the Korean Liver Cancer Association-National Cancer Center
4. Locally advanced unresectable or metastatic disease not amenable to curative surgical and/or locoregional therapies
5. Intolerant to or progressed on at least 1 prior systemic treatment for HCC
6. 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.
7. Child-Pugh class A or B7
8. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1
9. Life expectancy of at least 16 weeks
10. Adequate hematologic and hepatic function (should be obtained within 14 days prior to initiation of study treatment):
11. 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:

1. Fibrolamellar carcinoma or sarcomatoid carcinoma
2. Having active brain metastasis or leptomeningeal metastasis
3. Moderate to severe or intractable ascites
4. Presence of hepatic encephalopathy
5. Presence of active bacterial infection
6. Uncontrolled severe medical comorbidity
7. 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)
8. Other patients judged by the investigator or sub-investigator to be inappropriate as subjects of this study

Primary outcomes:
measure: Progression-free survival (PFS)
timeFrame: Until 12 months after the last patient was enrolled
measure: Safety (Adverse events)
timeFrame: Until 12 months after the last patient was enrolled
Secondary outcomes:
measure: Overall survival (OS)
timeFrame: Until 12 months after the last patient was enrolled
measure: Time to progression (TTP)
timeFrame: Until 12 months after the last patient was enrolled
measure: Objective response rate (ORR)
timeFrame: Until 12 months after the last patient was enrolled
measure: Disease control rate (DCR)
timeFrame: Until 12 months after the last patient was enrolled
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: National Cancer Center, Korea
Study officials:
affiliation: National Cancer Center, South Korea
name: Bo Hyun Kim, M.D.
role: PRINCIPAL_INVESTIGATOR
References: