CIK Treatment for HCC Patient Underwent Radical Resection | NCT01749865

Studies
CIK Treatment for HCC Patient Underwent Radical Resection

NCT01749865

Sponsor

Sun Yat-sen University

Status

Completed

Last Update Posted

Apr 14, 2016Estimated

Enrollment

200Actual

Phase

Phase 3

Conditions

Carcinoma, Hepatocellular

Interventions

Cytokine-Induced Killer Cells

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

Apr 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

Oct 2008

Primary Completion Date

Sep 2014Actual

Completion Date

Dec 2014Actual

First Submitted Date

Dec 12, 2012

First Submission Date that Met QC Criteria

Dec 12, 2012

First Posted Date

Dec 17, 2012Estimated

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

Apr 13, 2016

Last Update Posted Date

Apr 14, 2016Estimated

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

This is a randomized controlled study. About 200 patients with hepatocellular carcinoma who underwent radical resection will be included. The patients will be randomized to group A (receive CIK treatment) or group B (just regularly follow up) without any anti-cancer treatment after resection of HCC, and the randomize ratio will be 1:1.

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 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

200Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A, CIK	Experimental	Biological/Vaccine: Cytokine-Induced Killer Cells	Biological: Cytokine-Induced Killer Cells
B, CONTROL	No Intervention	Regular follow up with no intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cytokine-Induced Killer Cells	Biological	Cytokine-Induced Killer Cells treatment for 4 cycles	A, CIK

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Time to recurrence	To evaluate efficacy of CIK treatment as an adjuvant therapy in patients with hepatocellular carcinoma (HCC) who underwent radical resection.	5-year

Secondary Outcomes

Measure	Description	Time Frame
Disease Free Survival	Disease Free Survival	5 year

Other Outcomes

Measure	Description	Time Frame
Adverse Events	To evaluate safety of CIK treatment as an adjuvant therapy in patients with hepatocellular carcinoma (HCC) who underwent radical resection.	5 years

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male or female patients over 18 years of age.
Without any prior anti-cancer therapy.
Patients who have a life expectancy of at least 12 weeks.
Patients already had radical resection of HCC.

Definition of radical resection in this study:

All tumors were moved out, with a clean resection margin.
Number of tumors less than 3.
Without tumor invasion of the main trunk and first branch of the portal vein, or hepatic duct, or hepatic vein.
No hepatic hilum lymphnode metastasis.
No distance metastasis.
Hepatocellular carcinoma with histological diagnose.
No major post-operative complication.
Patients who have an performance status of 0, or 1.
Cirrhotic status of Child-Pugh class A only.
The following laboratory parameters:
Patients who give written informed consent.

Exclusion Criteria:

Previous or concurrent cancer that is distinct in primary site or histology from HCC.
History of cardiac disease.
Active clinically serious infections ( over grade 2 National Cancer Institute-Common Terminology Criteria for Adverse Events version 3.0)
Known history of human immunodeficiency virus (HIV) infection
Known Central Nervous System tumors including metastatic brain disease.
Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry.
History of organ allograft.
Known or suspected allergy to the investigational agent or any agent given in association with this trial.
Pregnant or breast-feeding patients.
Any condition that is unstable or which could jeopardize the safety of the patient and his/her compliance in the study.
Excluded therapies and medications, previous and concomitant:

Prior use of any anti-cancer treatment for HCC, eg. chemotherapy, radiotherapy. Antiviral treatment is allowed.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

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