Clinical trial · Interventional
Sorafenib Treatment in Patients With Hepatocellular Carcinoma With Microvascular Invasion After Radical Resection
A Prospective Multicenter Non-randomized Controlled Study of Sorafenib (Nexavar) Treatment in Patients With Hepatocellular Carcinoma With Microvascular Invasion After Radical Resection
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Midterm analysis showed negative results.
Summary
Brief summary (as posted)
This prospective multicenter non-randomized controlled study evaluates the efficacy and safety of treatment with Sorafenib (Nevaxar) in patients with hepatocellular carcinoma with microvascular invasion after radical resection compared to conventional therapies.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Recurrence | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Sorafenib | Drug | Sorafenib | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Sorafenib
- description
- Sorafenib (Nexavar) 200mg tablet, 2 tablets oral daily for 2 years, starting within 4weeks after hepatectomy. Regular treatment combined.
- interventionNames
- Drug: Sorafenib
- type
- NO_INTERVENTION
- label
- Control
- description
- No use of Sorafenib (Nexavar). Regular treatment.
Primary outcomes (1)
- measure
- Recurrence free survival
- timeFrame
- 2 years
- description
- To determine the recurrence free survival rate at 2 years after hepatectomy
Secondary outcomes (6)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age 18-75 years 2. Hepatocellular carcinoma confirmed by pathology 3. No macroscopic tumor thrombus vascular invasion and distant metastasis 4. R0 resection（clean resection margin both macroscopically and microscopically） 5. MVI confirmed by pathology 6. ECOG 0-1 7. Child-Pugh stage A 8. WBC \> 3×10E9/L；HB \> 90 G/L；PLT \> 50×10E9/L 9. ALT，AST not exceeding 5 times of the upper limit of normal value；CRE，TBIL not exceeding 1.5 times of the upper limit of normal value Exclusion Criteria: 1. Tumor rupture or invading to adjacent organs 2. Patients who underwent liver transplantation 3. Past history of or simultaneously receiving other anti-cancer therapy (such as TACE, chemotherapy, radiotherapy and others）and immune cell infusion therapy 4. Uncontrolled cardiovascular and cerebrovascular diseases 5. History of gastrointestinal bleeding within 6 months 6. Active infection other than HBV, HCV 7. Postoperative complications, not suitable to take Sorafenib (such as long term use of drainage due to bile leakage, poor wound healing and others) 8. Confirmed liver cancer recurrence or metastasis within 4 weeks after hepatectomy 9. Poor compliance, cannot adhere to regular follow up 10. Diagnosed with other original malignant tumors other than HCC
References
Publications (0)
Data not yet available