Clinical trial · Interventional
Adjuvant Hepatic Arterial Infusional Chemotherapy After Curative Resection of Hepatocellular Carcinoma
Adjuvant Hepatic Arterial Infusional Chemotherapy With 5-fluorouracil and Cisplatin After Curative Resection of Hepatocellular Carcinoma: A Prospective Randomized Study
- 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)
Several adjuvant therapies have been attempted to reduce uni-centric, and intra- or extrahepatic recurrence after curative surgical resection for hepatocellular carcinoma (HCC). However, because the efficacy of such adjuvant therapy remains unclear, there is no standard postoperative therapy. The investigators investigated whether adjuvant hepatic arterial infusional chemotherapy with 5-fluorouracil (5-FU) and cisplatin reduces the recurrence of HCC after curative 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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Adjuvant group | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Observation group
- description
- No adjuvant chemotherapy after resection
- type
- ACTIVE_COMPARATOR
- label
- Adjuvant group
- description
- Adjuvant chemotherapy after resection
- interventionNames
- Drug: Adjuvant group
Primary outcomes (1)
- measure
- 2-year recurrence rate and adverse events
- timeFrame
- 2-year
Secondary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * age of 18 to 70 years old * appropriate blood test results (white blood cells (WBCs) ≥3,000/mm3, platelet count ≥50,000/mm3, total bilirubin \<3mg/dl) * a patient could enter this study if one of the following was fulfilled 1. maximum diameter of HCC ≥5 cm, 2. microvascular or bile duct invasion upon pathological examination, 3. capsular invasion of HCC upon pathological examination, 4) Edmonson-Steiner grade III or IV. Exclusion Criteria: * patients with intra- or extrahepatic metastases at 4 weeks after resection * Child-Pugh class B or C (n = 4) * ECOG performance scale ≥2 * prior systemic chemotherapy, radiation, or locoregional therapy
References
Publications (0)
Data not yet available