Clinical trial · Interventional
Radiofrequency Ablation Accompanied With Spontaneous Sorafenib in Early to Intermediate Stage HCC
Radiofrequency Ablation Accompanied With Spontaneous Sorafenib Administration in the Treatment of Early to Intermediate Stage Hepatocellular Carcinoma: a Prospective Multicenter Cohort Study.(REASSESS)
- 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)
Radiofrequency ablation (RFA)can be curative with small localized HCCs up to 5 cm in diameter. However, the long-term prognosis is not satisfactory due to the high incidence of recurrence.Multimodality treatments are needed to prevent recurrences，but only useful with locoregional disease. Sorafenib is an oral multi-kinase inhibitor and the only systemic drug associated with improved overall survival (OS) in patients with advanced HCC. Retrospective and randomized studies have suggested that the combined use of Sorafenib may be useful in patients with unresectable HCC. Based on these information and the multiple actions of Sorafenib, we hypothesized that Sorafenib plus RFA may be useful in patients with early to Mid term HCC. In this investigation, we evaluated the safety and efficacy of a combination Sorafenib and RFA therapy in patients with Barcelona Clinic Liver Cancer (BCLC) Stage 0 -B1 HCC in a multicenter prospective cohort study.
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 |
|---|---|---|---|
| HCC | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Radiofrequency ablation | Procedure | — | UNRESOLVED |
| radiofrequency ablation plus Sorafenib | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Sorafenib+RFA
- description
- We give radiofrequency ablation plus Sorafenib for the treatment of HCC
- interventionNames
- Procedure: radiofrequency ablation plus Sorafenib
- type
- ACTIVE_COMPARATOR
- label
- RFA alone
- description
- We give Radiofrequency ablation alone for the treatment of HCC
- interventionNames
- Procedure: Radiofrequency ablation
Primary outcomes (1)
- measure
- 2-year incidence of tumor recurrence
- timeFrame
- 2 year
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Authorization of Informed Consent * HCC diagnosed by biopsy or Image findings * BCLC stage 0 to B1 * This time was the primary treatment of HCC. Had no history of any tumor specific therapy,including RFA,Hepatectomy,TACE,HIFU,and Transplantation * Child Pugh A or B * ECOG 0 to 2 * single lesion less than or equal to 5 cm,2 to 3 nodules, maximal size less than equal to 3cm * Male or female (without pregnancy) * Ages between 18 to 70 years * Capable of take medicines * anticipate at least survival of 12 weeks * Unwilling to receive surgical resection or liver transplantation * Potentially curable disease by RFA * Sorafenib administrated less than 4 weeks before or after RFA procedures * For any excuse,subject should take Sorafenib at least for 4 weeks Exclusion Criteria: * A cancer embolus in major hepatic vessels or extrahepatic metastases * Tumor number more than 4 or tumor size larger than 5 cm * A present or past history of uncontrollable ascites, hepatic encephalopathy or variceal bleeding * A history of a secondary malignancy * Severe dysfunction of the heart, kidney or other organs * Active infection except viral hepatitis * Any treatment history of target lesion including chemotherapy and TACE * Pregnancy * received other trials on gene therapy * have received operation less than 4 weeks
References
Publications (0)
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