The Effect of Fluorouracil Implants Regional Chemotherapy During the Surgical Treatment for Early Stage Hepatocellular Carcinoma
NCT ID: NCT01055743
Last Updated: 2010-01-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
250 participants
INTERVENTIONAL
2009-08-31
2014-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Radical resection + Fluorouracil Implants
Radical resection
Radical resection of hepatocellular carcinoma
Fluorouracil Implants
Implanted during the surgical treatment
Radical resection
Radical resection
Radical resection of hepatocellular carcinoma
Interventions
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Radical resection
Radical resection of hepatocellular carcinoma
Fluorouracil Implants
Implanted during the surgical treatment
Eligibility Criteria
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Inclusion Criteria
* Child-Pugh class A, B
* Radical resection is feasible
* Patients with adequate renal, hepatic, and hematologic function
* Written informed consent
Exclusion Criteria
* No measurable lesion
* Receive chemotherapy, radiotherapy or biotherapy within 30 days prior to enrollment
* Evidence of serious infection
* Renal or hepatic dysfunction, significant cardiovascular disease
* Pregnant or lactating women
18 Years
75 Years
ALL
No
Sponsors
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Eastern Hepatobiliary Surgery Hospital
OTHER
Simcere Pharmaceutical Co., Ltd
OTHER
Responsible Party
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Eastern Hepatobiliary Surgery Hospital
Principal Investigators
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Shuqun Cheng, MD
Role: PRINCIPAL_INVESTIGATOR
Eastern Hepatobiliary Surgery Hospital
Locations
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Eastern Hepatobiliary Surgery Hospital
Shanghai, , China
Countries
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Central Contacts
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Shuqun Cheng, MD
Role: CONTACT
Facility Contacts
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Shuqun Cheng, MD
Role: primary
Other Identifiers
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2009PHC001
Identifier Type: -
Identifier Source: org_study_id
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