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

NCT05117957 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2025-12-31

No results posted yet for this study

Summary

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

Conditions

Interventions

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.

Sponsors & Collaborators

  • Bo Hyun Kim

    lead OTHER_GOV

Principal Investigators

  • Bo Hyun Kim, M.D. · National Cancer Center, South Korea

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-08
Primary Completion
2025-06-30
Completion
2025-12-18

Countries

  • South Korea

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05117957 on ClinicalTrials.gov