Adjuvant Anti-Recurrence Treatment With Rapamycin on Earl... | NCT02724332

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

NCT02724332

Sponsor

Eastern Hepatobiliary Surgery Hospital

Status

Completed

Last Update Posted

Mar 31, 2016Estimated

Enrollment

300Actual

Phase

Phase 1

Conditions

Hepatocellular Carcinoma
Rapamycin

Interventions

Rapamycin

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2012

Primary Completion Date

Jun 2015Actual

Completion Date

Dec 2015Actual

First Submitted Date

Mar 28, 2016

First Submission Date that Met QC Criteria

Mar 28, 2016

First Posted Date

Mar 31, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 28, 2016

Last Update Posted Date

Mar 31, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

ShenFeng, vice president of the Eastern Hepatobiliary Surgery Hospital, Eastern Hepatobiliary Surgery HospitalPrincipal Investigator

Lead Sponsor

Eastern Hepatobiliary Surgery HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

300Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
control group	No Intervention	Patients will be treated with radical hepatectomy only.
transcatheter arterial chemoembolization	Active Comparator	Patients will be treated with TACE	Drug: Rapamycin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Rapamycin	Drug	2mg,po,bid	transcatheter arterial chemoembolization

Measure	Description	Time Frame
Overall Survival		3 years

Measure	Description	Time Frame
Time to recurrence		3 years

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Eastern hepatobilliary surgery hospital		Shanghai	Shanghai Municipality	200438	China

Condition Browse Module

MeSH Terms

ID	Term
D006528	Carcinoma, Hepatocellular

Ancestor Terms

ID	Term
D000230	Adenocarcinoma
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D020123	Sirolimus

Ancestor Terms

ID	Term
D018942	Macrolides
D007783	Lactones
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided