The Efficacy of 5-fluorouracil/Mitomycin for the Patients With Pulmonary Metastasis of Hepatocellular Carcinoma

Phase 2

Withdrawn

• Conditions: Hepatocellular Carcinoma; Lung Metastasis
• Interventions: Drug: 5-fluorouracil; Drug: Mitomycin

• Registration Number: NCT01953406
• Lead Sponsor: Seoul National University Hospital

Brief Summary

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.

Detailed Description

Extrahepatic metastasis of hepatocellular carcinoma has recently been paradoxically increasing due to increased survival with effective locoregional therapies. Sorafenib is the first systemic agent that has demonstrated a significant survival benefit in patients with advanced HCC; however, the modest improvement of 3 months is far from satisfactory. There is no convincing evidence, to date, that systemic chemotherapy when tumor progresses after sorafenib therapy improves overall survival. The combination of anticancer agents is important to achieve favourable clinical results. For patients with metastatic liver cancer or HCC, some studies have discussed the effectiveness of 5-fluorouracil/mitomycin(FM). However, few studies have examined the actual FM regimen for HCC.

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.

Study Timeline

• Study First Submitted: 2013-09-21
• Study First Submitted QC: 2013-09-24
• Study First Posted: 2013-10-01
• Study Start: 2015-11
• Primary Completion: 2015-11
• Study Completion: 2015-11
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-26
• Last Update Posted: 2016-04-27

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
The 5-fluorouracil/mitomycin group	5-fluorouracil	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
The 5-fluorouracil/mitomycin group	Mitomycin	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

Primary Outcome Measures

Name	Time	Method
Time-to-progression(TTP)of lung metastasis	every 12 weeks, up to 36 weeks

Secondary Outcome Measures

Name	Time	Method
Response rates(CR + PR)of lung metastasis	every 12 weeks, up to 36 weeks
progression free survival	every 12 weeks, up to 36 weeks
Overall survival	every 12 weeks, up to 36 weeks
Time to recurrence of intrahepatic tumor	every 12 weeks, up to 36 weeks
Disease control rates (CR + PR + SD)of lung metastasis	every 12 weeks, up to 36 weeks

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of