Study of Cytokine-induced Killer Cell (CIK) Treatment in Patients After Resection of Liver Cancer

NCT ID: NCT00769106

Last Updated: 2016-04-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-06-30
• Study Completion Date: 2014-12-31

Brief Summary

Study hypothesis:

The recurrence rate of HCC patients after radical resection is about 60-70%. This study is based on the hypothesis that CIK treatment could decrease the recurrence rate by 15% to 20%.

Abstract:

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.

Study treatment:

Patients in group A will receive 4 cycles of CIK treatments within 3 months after their liver resection. Patients in group B will have no anti-cancer therapy. Anti-virus and other supportive therapies are available in both groups.

Conditions

Hepatocellular Carcinoma

Study Design

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

Study Groups

B (control group)

regular treatment and follow up

Group Type: NO_INTERVENTION

No interventions assigned to this group

A (CIK group)

cytokine-induced killer cell treatment plus regular treatment and follow up

Group Type: EXPERIMENTAL

cytokine-induced killer cell (CIK) treatment

Intervention Type: BIOLOGICAL

cytokine-induced killer cell treatment every two weeks, for 4 cycles

Interventions

cytokine-induced killer cell (CIK) treatment

cytokine-induced killer cell treatment every two weeks, for 4 cycles

Intervention Type: BIOLOGICAL

Other Intervention Names

CIK

Eligibility Criteria

Inclusion Criteria

• Male or female patients > 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 <= 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 ECOG PS of 0, or 1.
• Cirrhotic status of Child-Pugh class A only.
• The following laboratory parameters:

• Platelet count >= 70 x 109/L
• Hemoglobin >= 8.5 g/dL
• Albumin >= 3.5 g/dL
• Total bilirubin <= 25umol/L
• Alanine transaminase (ALT) and AST <= 2.5 x upper limit of normal
• Serum creatinine <= 1.5 x the upper limit of normal
• Prothrombin time (PT) <= 3 seconds above control.
• 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 (> grade 2 National Cancer Institute [NCI]-Common Terminology Criteria for Adverse Events [CTCAE] 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
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

LI Sheng-ping

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jin-qing Li, M.D.

Role: PRINCIPAL_INVESTIGATOR

Sun Yat-sen University

Locations

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Countries

China

Other Identifiers

SunYat-senU 5010

Identifier Type: -

Identifier Source: org_study_id