Clinical trial · Interventional
The Efficacy of 5-fluorouracil/Mitomycin for the Patients With Pulmonary Metastasis of Hepatocellular Carcinoma
Phase II Study Evaluating the Efficacy of 5-fluorouracil/Mitomycin for the Patients With Pulmonary Metastasis of Hepatocellular Carcinoma Who Had Progressive Disease With Sorafenib
NCT01953406CI-TRIAL-00021925withdrawnPhase 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): No participants were enrolled. Therefore, we stop this study, prematurely.
Summary
Brief summary (as posted)
The aim of this study is to evaluate the efficacy of 5-fluorouracil + Mitomycin for the patients with pulmonary metastasis of hepatocellular carcinoma who had progressive disease with sorafenib.
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 |
| Lung Metastasis | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 5-fluorouracil | Drug | Fluorouracil | ALIAS |
| Mitomycin | Drug | Mitomycin | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- The 5-fluorouracil/mitomycin group
- description
- Systemic chemotherapy with 5-fluorouracil/mitomycin 5-fluorouracin 15mg/kg/day D1-6 civ + Mitomycin 4mg/day iv push D1,4 till progression, every 4 weeks
- interventionNames
- Drug: 5-fluorouracil
- Drug: Mitomycin
Primary outcomes (1)
- measure
- Time-to-progression(TTP)of lung metastasis
- timeFrame
- every 12 weeks, up to 36 weeks
Secondary outcomes (5)
- measure
- Overall survival
- timeFrame
- every 12 weeks, up to 36 weeks
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Patients who have received previous local therapy treatments for the intrahepatic hepatocellular carcinoma (RFA, PEI, cryoablation, surgery, resection) and who don't have any viable intrahepatic tumor within 3 months of imaging (dynamic liver CT or liver MRI) after the locoregional therapy * Patients who have measurable lung metastasis * Patients who have received their last dose of sorafenib more than 14 days before and who had progressive disease of lung metastasis with sorafenib * Patients who have risk factors of hepatocellular carcinoma (chronic hepatitis B, chronic hepatitis C, liver cirrhosis) * Age : 18 years to 80 years * ECOG Performance Status of 0 to 2 * Child-Pugh class A,B (Child-Pugh score 5-9) * Adequate bone marrow, liver function as assessed by the following laboratory requirements to be conducted within 7 days prior to screening: * WBC count \> 1,000/mm3 * Absolute neutrophil count \> 500/mm3 * Hb \> 7.0 g/dL * Platelet count \> 50,000 /mm3 * Bilirubin \< 3 mg/dL * Adequate clotting function: INR \< 2.3 or \< 6sec Exclusion Criteria: * Child-Pugh score \> 10 * ECOG Performance Status \> 3 * History of organ allograft * Patients with uncontrolled co-morbidity which needs treatment * Patients who have received prior systemic chemotherapy except sorafenib
References
Publications (0)
Data not yet available
No reference posted for this study.