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

NCT05117957 | Completed Phase 2

• 1 other identifier: SOPT study 2021
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Advanced Hepatocellular Carcinoma

Keywords

HCC; Sorafenib

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Overall survival (OS)

  Until 12 months after the last patient was enrolled

• Time to progression (TTP)

  Until 12 months after the last patient was enrolled

• Objective response rate (ORR)

  Until 12 months after the last patient was enrolled

• Disease control rate (DCR)

  Until 12 months after the last patient was enrolled

Study Arms (1)

Sorafenib

EXPERIMENTAL

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

Interventions

Sorafenib DRUG

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.

Sorafenib

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Bo Hyun Kim: lead

Study Sites (1)

National Cancer Center, Korea

Seoul, South Korea

Location

MeSH Terms

Interventions

Sorafenib

Intervention Hierarchy (Ancestors)

Phenylurea Compounds; Urea; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Niacinamide; Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Study Officials

• Bo Hyun Kim, M.D.

  National Cancer Center, South Korea

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Adjunct Associate Professor, Senior Scientist

Study Record Dates

• First Submitted: October 21, 2021
• First Posted: November 11, 2021
• Study Start: March 8, 2022
• Primary Completion: June 30, 2025
• Study Completion: December 18, 2025
• Last Updated: December 31, 2025

Record last verified: 2025-12

Locations

KR (1)