CIK Treatment for HCC Patient Underwent Radical Resection

NCT ID: NCT01749865

Last Updated: 2016-04-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-10-31
• Study Completion Date: 2014-12-31

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.

Conditions

Carcinoma, Hepatocellular

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

A, CIK

Biological/Vaccine: Cytokine-Induced Killer Cells

Group Type: EXPERIMENTAL

Cytokine-Induced Killer Cells

Intervention Type: BIOLOGICAL

Cytokine-Induced Killer Cells treatment for 4 cycles

B, CONTROL

Regular follow up with no intervention

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Cytokine-Induced Killer Cells

Cytokine-Induced Killer Cells treatment for 4 cycles

Intervention Type: BIOLOGICAL

Other Intervention Names

CIK

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

LI Sheng-ping

Vice director, Sun Yat-sen University Cancer Center

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Immunotherapy

Guangzhou, Guangdong, China

Countries

China

Other Identifiers

2007043-HCC012

Identifier Type: -

Identifier Source: org_study_id