Clinical trial · Interventional
Intraoperative Chemotherapy Against Hepatocellular Carcinoma Recurrence
Clinical Randomized Control Trial of Intraoperative Implanting Chemotherapeutic Drugs Sustained Release Following Resection of Hepatocellular Carcinoma Against Postoperative Short-term Recurrence
- 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)
Hepatectomy is still the most important treatment for HCC.High recurrence rate mostly influence it's prognosis, especially for the patient with tumor \>5cm, multiple tumor and who cannot accept R0 resection.Our retrospective study showed sustained released 5-FU implanted into the liver incisal margin after tumor was resected could reduce the recurrence rate of HCC after liver resection.According to this, we proceed this RCT to prospectively observe the effect of sustained released 5-FU,and we also want to know whether combined with sustained released cisplatin will get better effect in preventing the tumor recurrence,especially in short time after liver resection.
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 |
|---|---|---|---|
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| sustained released 5-FU | Drug | — | UNRESOLVED |
| sustained released 5-FU and sustained released cisplatin | Drug | — | UNRESOLVED |
| TACE | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- 5-FU+Cisplatin
- description
- 50 HCC patients will be implanted 600mg sustained released 5-FU and 60mg sustained released cisplatin into liver incisal margin after tumor is resected.
- interventionNames
- Drug: sustained released 5-FU and sustained released cisplatin
- Procedure: TACE
- type
- ACTIVE_COMPARATOR
- label
- 5-FU
- description
- 50 HCC patients will be implanted 600mg sustained released 5-FU into liver incisal margin after tumor is resected.
- interventionNames
- Drug: sustained released 5-FU
- Procedure: TACE
- type
- EXPERIMENTAL
- label
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. tumor \>5cm; 2. multiple tumor located in one liver lobe; 3. margin of tumor is not clear; 4. cutting edge to tumor \<1cm; 5. portal vein branch invasion; 6. without extra-liver metastasis; 7. patient's liver function and condition is able to accept hepatectomy. Exclusion Criteria: 1. single tumor \<=5cm; 2. multiple tumor located more than in one liver lobe; 3. margin of tumor is clear; 4. cutting edge to tumor \>=1cm; 5. portal vein stem invasion 6. extra-liver metastasis; 7. patient's liver function and condition cannot accept hepatectomy.
References
Publications (0)
Data not yet available