NCT05117957

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Bo Hyun Kim · Other Government
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Advanced Hepatocellular Carcinoma

Interventions

Type	Name	Description
DRUG	Sorafenib	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.

Timeline

• Start date: 2022-03-08
• Primary completion: 2025-06-30
• Completion: 2025-12-18
• First posted: 2021-11-11
• Last updated: 2025-12-31

Locations

1 site across 1 country: South Korea