Clinical trial · Interventional
Efficacy and Safety of Sorafenib in Previously Treated Advanced Hepatocellular Carcinoma: SOPT Study
NCT05117957CI-TRIAL-00119202completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To investigate the efficacy and safety of sorafenib administered as later lines of treatment in patients with advanced HCC.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Hepatocellular Carcinoma | Hepatocellular Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Sorafenib | Drug | Sorafenib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Sorafenib
- description
- 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).
- interventionNames
- Drug: Sorafenib
Primary outcomes (2)
- measure
- Progression-free survival (PFS)
- timeFrame
- Until 12 months after the last patient was enrolled
- description
- 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.
- measure
- Safety (Adverse events)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.