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

Information source: Seoul National University Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hepatocellular Carcinoma; Lung Metastasis

Intervention: 5-fluorouracil (Drug); Mitomycin (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: Seoul National University Hospital

Official(s) and/or principal investigator(s):
Jung-Hwan Yoon, M.D., Ph.D., Principal Investigator, Affiliation: Seoul National University Hospital

Overall contact:
Jung-Hwan Yoon, Professor, Phone: +82-2-2072-2731, Email: yoonjh@snu.ac.kr

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.

Clinical Details

Official title: 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

Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Time-to-progression(TTP)of lung metastasis

Secondary outcome:

Overall survival

Response rates(CR + PR)of lung metastasis

progression free survival

Time to recurrence of intrahepatic tumor

Disease control rates (CR + PR + SD)of lung metastasis

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.

Eligibility

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.

Criteria:

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

Locations and Contacts

Jung-Hwan Yoon, Professor, Phone: +82-2-2072-2731, Email: yoonjh@snu.ac.kr

Seoul National University Hospital, Seoul, Korea, Republic of; Recruiting
Jung-Hwan Yoon, M.D., Ph.D., Phone: +82-2-2072-2731, Email: yoonjh@snu.ac.kr
Yuri Cho, M.D., Phone: +82-2-740-8112, Email: presh_yuri@hanmail.net
Additional Information

Starting date: September 2013
Last updated: November 26, 2014

Page last updated: August 23, 2015

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