Advanced Hepatocellular CarcinomaPhase 2NCT05117957
Efficacy and Safety of Sorafenib in Previously Treated Advanced Hepatocellular Carcinoma: SOPT Study
A Phase 2 study testing Sorafenib in people with Advanced Hepatocellular Carcinoma, run by Bo Hyun Kim at 1 site in South Korea.
Trial summary
To investigate the efficacy and safety of sorafenib administered as later lines of treatment in patients with advanced HCC. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Advanced Hepatocellular Carcinoma
- What is being tested?
- Sorafenib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSouth Korea
- Study dates
- 8 Mar 2022to 18 Dec 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
To investigate the efficacy and safety of sorafenib administered as later lines of treatment in patients with advanced HCC.
Read the 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
- Being tested
- Sorafenib
- Keywords
- HCC, Sorafenib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SorafenibDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Drug: Sorafenib |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Until 12 months after the last patient was enrolled
Safety (Adverse events)
Incidence of adverse events will be evaluated.
Measured: Until 12 months after the last patient was enrolled
Secondary outcomes (4)
Overall survival (OS)
OS is defined as the time from the date of treatment initiation to the date of death.
Measured: Until 12 months after the last patient was enrolled
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).
Measured: Until 12 months after the last patient was enrolled
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).
Measured: Until 12 months after the last patient was enrolled
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).
Measured: Until 12 months after the last patient was enrolled
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2021
- Study start8 Mar 2022
- Primary completion30 Jun 2025
- Study completion18 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Hepatocellular CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bo Hyun Kim
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Bo Hyun Kim, National Cancer Center, Korea
- Investigators
- Bo Hyun Kim, M.D., Principal investigator, National Cancer Center, South Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05117957
- Sponsor's protocol ID
- SOPT study 2021
- Status last verified
- Jul 2026
- First submitted
- 21 Oct 2021
- Last updated
- 24 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Sorafenib in Previously Treated Advanced Hepatocellular Carcinoma: SOPT Study
- ClinicalTrials.gov ID
- NCT05117957
- Acronym / sponsor ID
- SOPT study 2021
- Conditions
- Advanced Hepatocellular Carcinoma
- Keywords
- HCC, Sorafenib
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Bo Hyun KimOther government
- Study start
- 8 Mar 2022 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 18 Dec 2025 (actual)
- First posted
- 11 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sorafenib | Experimental | Drug: SorafenibSorafenib 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). |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SorafenibSubjects 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. | Drug | Sorafenib |
Primary outcome
Progression-free survival (PFS)
Time frame: Until 12 months after the last patient was enrolled
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)
Time frame: Until 12 months after the last patient was enrolled
Incidence of adverse events will be evaluated.
4 secondary outcomes
Overall survival (OS)
Time frame: Until 12 months after the last patient was enrolled
Time to progression (TTP)
Time frame: Until 12 months after the last patient was enrolled
Objective response rate (ORR)
Time frame: Until 12 months after the last patient was enrolled
Disease control rate (DCR)
Time frame: Until 12 months after the last patient was enrolled
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bo Hyun Kim, M.D. principal investigator
National Cancer Center, South Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sorafenib in people with Advanced Hepatocellular Carcinoma, run by Bo Hyun Kim at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (PFS) (time frame: Until 12 months after the last patient was enrolled). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2026.