Clinical trial · Interventional
The Effect of Fluorouracil Implants Regional Chemotherapy During the Surgical Treatment for Early Stage Hepatocellular Carcinoma
A Randomized, Controlled Trial of Fluorouracil Implants Regional Chemotherapy During the Surgical Treatment for Early Stage Hepatocellular Carcinoma
NCT01055743CI-TRIAL-00003062unknownPhase 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)
This study will assess the clinical efficacy and safety of fluorouracil implants regional chemotherapy during the surgical treatment for early-stage hepatocellular carcinoma.
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 |
|---|---|---|---|
| Early Stage Hepatocellular Carcinoma | Early Stage Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fluorouracil Implants | Drug | — | UNRESOLVED |
| Radical resection | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Radical resection + Fluorouracil Implants
- interventionNames
- Procedure: Radical resection
- Drug: Fluorouracil Implants
- type
- ACTIVE_COMPARATOR
- label
- Radical resection
- interventionNames
- Procedure: Radical resection
Primary outcomes (1)
- measure
- To assess the clinical benefit of fluorouracil implants regional chemotherapy during the radical resection in early stage hepatocellular carcinoma patients. The primary endpoint is disease-free survival (DFS).
- timeFrame
- 1, 2, and 3 years
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Histological diagnosis of stage I hepatocellular carcinoma * Child-Pugh class A, B * Radical resection is feasible * Patients with adequate renal, hepatic, and hematologic function * Written informed consent Exclusion Criteria: * Allergic to chemotherapy drugs * No measurable lesion * Receive chemotherapy, radiotherapy or biotherapy within 30 days prior to enrollment * Evidence of serious infection * Renal or hepatic dysfunction, significant cardiovascular disease * Pregnant or lactating women
References
Publications (0)
Data not yet available
No reference posted for this study.