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

Hepatocellular Carcinoma Clinical Trial

— HCC-CIK  

Official title:

A Randomized Controlled Study of Cytokine-induced Killer Cell (CIK) Treatment in Patients With Hepatocellular Carcinoma Who Underwent Radical Resection.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00769106
• Other study ID #: SunYat-senU 5010
• Status: Completed
• Phase: Phase 3
• First received: October 7, 2008
• Last updated: April 13, 2016
• Start date: June 2008
• Est. completion date: December 2014

Study information

• Verified date: February 2015
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: December 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Biological:
• cytokine-induced killer cell (CIK) treatment
cytokine-induced killer cell treatment every two weeks, for 4 cycles

Locations

Country	Name	City	State
China	Sun Yat-sen University Cancer Center	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to recurrence (TTR)		month	No
Secondary	Overall survival (OS)		month	No
Secondary	Progression Free Survival (PFS)		month	No
Secondary	Laboratory findings		every 3 months	Yes
Secondary	AEs and SAEs		monthly	Yes