Adjuvant Anti-Recurrence Treatment With Rapamycin on Early-stage HCC

NCT ID: NCT02724332

Last Updated: 2016-03-31

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-30

Study Completion Date

2015-12-31

Brief Summary

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To evaluate the clinical effect of rapamycin combined with TACE on early-stage HCC with overexpression of ASPH after radical surgery using randomized controlled study and provide a new anti-recurrence treatment for HCC patients after operation.

Detailed Description

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Conditions

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Hepatocellular Carcinoma Rapamycin

Keywords

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Aspartate beta hydroxylase transcatheter arterial chemoembolization

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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control group

Patients will be treated with radical hepatectomy only.

Group Type NO_INTERVENTION

No interventions assigned to this group

transcatheter arterial chemoembolization

Patients will be treated with TACE

Group Type ACTIVE_COMPARATOR

Rapamycin

Intervention Type DRUG

2mg,po,bid

Interventions

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Rapamycin

2mg,po,bid

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Via clinical diagnosis and confirm it is primary liver cancer
2. Pathological evidence of HCC
3. Estimate tumor can gain treatment of curing operation
4. No evidence for extrahepatic metestasis
5. liver function :Child-Pugh A/B
6. BCLC stage:0/1;TNM stage:Ⅰ

Exclusion Criteria

1. reject to attend;
2. impossible to come to our hospital for physical examination regularly.
3. cancer epitome、seed focus、lymph node or distant metastasis
4. Blood clotting function hindrance; 5, Patients with other diseases which may affect the treatment mentioned.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eastern Hepatobiliary Surgery Hospital

OTHER

Sponsor Role lead

Responsible Party

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ShenFeng

vice president of the Eastern Hepatobiliary Surgery Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Eastern hepatobilliary surgery hospital

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

Other Identifiers

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ZD201206003-P1

Identifier Type: -

Identifier Source: org_study_id