Clinical trial · Interventional
Effect of Intraoperative Controlled Release 5-Fluorouracil Therapy on Recurrence in Hepatocellular Carcinoma Patients
A Randomized Controlled Study on the Effect of Intraoperative Controlled Release 5-Fluorouracil Therapy on Anti-tumor Recurrence in Hepatocellular Carcinoma Patients With High Risk of Microvascular Invasion Presence
NCT02523053CI-TRIAL-00024390unknownN/AClinicalTrials.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)
The aim of this study is to confirmed the role of intraoperative controlled release 5-Fluorouracil therapy in the prevention of recurrence after surgery for HCC patients with high risk of preoperative prediction of microvascular invasion.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 5-Fluorouracil | Drug | Fluorouracil | ALIAS |
| Hepatectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Hepatectomy
- description
- Surgical removal of all lesions
- interventionNames
- Procedure: Hepatectomy
- type
- EXPERIMENTAL
- label
- Hepatectomy plus 5-Fluorouracil
- description
- Surgical removal of all lesions and intraoperative controlled release 5-Fluorouracil therapy
- interventionNames
- Procedure: Hepatectomy
- Drug: 5-Fluorouracil
Primary outcomes (1)
- measure
- Time to tumor recurrence
- timeFrame
- 5 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. Male or female patients \> 18 years and \<=70 years of age 2. Patients preoperatively diagnosed of hepatocellular carcinoma according to the criteria of American Association for the Study of Liver Diseases(AASLD) 3. Within Milan criteria 4. Nomogram score for MVI prediction \>200 5. Preoperative ECOG criteria score of 0-1 6. Child-Pugh class A liver function 7. No Anticancer treatment before surgery Exclusion Criteria: 1. Major portal/hepatic vein invasion 2. Extrahepatic metastasis 3. Patients with apparent cardiac, pulmonary, cerebral and renal dysfunction,which may affect the treatment of liver cancer 4. Lost to follow-up 5. Patients participating in other clinical trials 6. Patients refused to join our trial 7. Pregnant and breast-feeding women
References
Publications (0)
Data not yet available
No reference posted for this study.