Clinical trial · Interventional
Comparison Study of Sorafenib and 5-fluorouracil/Mitomycin for Metastatic Hepatocellular Carcinoma
An Open Label, Phase 2 Trial Comparing Sorafenib and 5-fluorouracil/Mitomycin in Hepatocellular Carcinoma With Pulmonary Metastasis
NCT01171482CI-TRIAL-00027219terminatedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): There were problems with national reimbursement policies.
Summary
Brief summary (as posted)
The aim of this study is to compare the efficacy of sorafenib to 5-fluorouracil/mitomycin in HCC patients with pulmonary metastasis whose intrahepatic tumors has been controlled with locoregional therapies.
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 |
|---|---|---|---|
| Carcinoma, Hepatocellular | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 5-FU | Drug | Fluorouracil | ALIAS |
| Mitomycin | Drug | Mitomycin | ALIAS |
| sorafenib | Drug | Sorafenib | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- The FM group
- description
- Patients in the FM group will be administered 5-FU plus mitomycin
- interventionNames
- Drug: 5-FU
- Drug: Mitomycin
- type
- ACTIVE_COMPARATOR
- label
- The sorafenib group
- description
- Patients in the sorafenib group will be administered sorafenib
- interventionNames
- Drug: sorafenib
Primary outcomes (1)
- measure
- Progression free survival (PFS)
- timeFrame
- every 8 weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with clinical or histological diagnosis of HCC based on the guidelines of the AJCC * Patients with at least one, bi-dimensionally measurable, pulmonary metastasis without intrahepatic viable tumor (Viable tumor is defined as uptake of contrast agent in the arterial phase of dynamic CT or MRI.) * Patients who have received previous local therapy treatments (RFA, PEI, cryoablation, surgery, resection) to non-target lesions are eligible * Age : 20 years to 80 years * ECOG Performance Status of 0 to 1 * Child-Pugh class A or B (Child-Pugh score 7) * Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted within 7 days prior to screening: * Hb ≧ 9 g/dL * Absolute neutrophil count \> 1000/mm3 * Platelet count ≧ 60,000 /mm3 * Adequate clotting function: INR \< 1.5 * Hepatic: AST and ALT \< 5 X ULN * Renal: serum creatinine \< 1.7mg/dL * Bilirubin ≦ 3 mg/dL Exclusion Criteria: * Patients with diffuse infiltrative type of HCC that are poorly defined * Presence of hepatic encephalopathy and intractable ascites * Patients who are on a liver transplant list * The patient has received prior systemic chemotherapy * History of organ allograft * Active clinically serious infections (\> grade 2 NCI-CTC version 3.0), including spontaneous bacterial peritonitis * History of cardiac disease: congestive heart failure \> NYHA class 2; active coronary artery disease (myocardial infarction more than 6 months prior to study entry is allowed), cardiac arrhythmias requiring anti-arrhythmic therapy or uncontrolled hypertension and diabetes mellitus * Previous or concurrent cancer that is distinct in primary site or histology from HCC, EXCEPT cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors (Ta, Tis \& T1). Any cancer curatively treated \> 3 years prior to entry is permitted * HIV infection or AIDS-related illness or serious acute or chronic illness (based on medical history)
References
Publications (0)
Data not yet available
No reference posted for this study.