Clinical trial · Interventional
P2 Study of Postoperative Interferon/Fluorouracil vs Cisplatin/Fluorouracil for Hepatocellular Carcinoma.
Randomised Phase II Study of Postoperative Hepatic Arterial Infusion Chemotherapy (Interferon/Fluorouracil Versus Low-dose Cisplatin/Fluorouracil) for Hepatocellular Carcinoma With Portal Vein Tumor Thrombus.
NCT01834963CI-TRIAL-00033009unknownPhase 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)
To evaluate the efficacy and safety of postoperative hepatic arterial infusion chemotherapy, interferon/fluorouracil versus low-dose cisplatin/fluorouracil, in patients with hepatocellular carcinoma with portal vein tumor thrombus.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cisplatin、Fluorouracil | Drug | — | UNRESOLVED |
| Interferon Alfa、Fluorouracil | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Interferon Alfa、Fluorouracil
- description
- Interferon Alfa 5×10⁶International Unit(IU)/body subcutaneously 3 times a week for 4 weeks Fluorouracil 300mg/m2, day1-5,8-12, every 6 weeks
- interventionNames
- Drug: Interferon Alfa、Fluorouracil
- type
- EXPERIMENTAL
- label
- Cisplatin、Fluorouracil
- description
- Cisplatin 20mg/m2 ,day1,8,22,29, every 6 weeks Fluorouracil 300mg/m2, day1-5,8-12,22-26,29-33, every 6 weeks
- interventionNames
- Drug: Cisplatin、Fluorouracil
Primary outcomes (1)
- measure
- Two-year overall survival rate
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: 1. hepatocellular carcinoma with histological or evidence or typical findings by CT or MRI. 2. surgically resectable tumors with tumor thrombus in first branch or main trunk of portal vein. 3. 20 years old or more. 4. Eastern Cooperative Oncology Group Performance status of 0 or 1. 5. Life expectancy of at least 6 months at the pre-treatment evaluation. 6. Child-Pugh class A or B. 7. Adequate bone marrow, liver and renal function, as assessed by the following laboratory requirements. white blood cell count \>= 2000/microliter, Neutrophil \>= 1000/microliter, Hemoglobin \>= 9.0 g/dL, Platelet count \>= 75000/microliter, Total Bilirubin \<= 1.5mg/dl, aspartate aminotransferase(AST) /alanine aminotransferase(ALT) \<= 150 IU/L, Serum creatinine \<= 1.2mg/dL, Creatinine clearance \>= 60 ml/min \- Exclusion Criteria: 1. Histological diagnosed combined hepatocellular and cholangiocellular carcinoma. 2. Extrahepatic tumor spread which affects patient's prognosis. 3. Hepatic encephalopathy 4. Active infections except for hepatitis B virus(HBV) and hepatitis C virus(HCV). 5. Sever complications (interstitial pneumonia, heart failure, renal failure, liver failure, ileus, incontrollable diabetes mellitus, and so on) 6. Active double cancer 7. Pregnancy 8-10) Medication or treatment that may affect to the absorption of drug or pharmacokinetics. 11\) others, in the investigator's judgment. \-
References
Publications (0)
Data not yet available
No reference posted for this study.