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

NCT00769106 | Completed Phase 3 DMC

• 1 other identifier: SunYat-senU 5010
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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

Keywords

hepatocellular carcinoma; recurrent; cytokine-induced killer cell

Outcome Measures

Primary Outcomes (1)

• Time to recurrence (TTR)

  month

Secondary Outcomes (4)

• Overall survival (OS)

  month

• Progression Free Survival (PFS)

  month

• Laboratory findings

  every 3 months

• AEs and SAEs

  monthly

Study Arms (2)

B (control group)

NO INTERVENTION

regular treatment and follow up

A (CIK group)

EXPERIMENTAL

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

Biological: cytokine-induced killer cell (CIK) treatment

Interventions

cytokine-induced killer cell (CIK) treatment BIOLOGICAL

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

Also known as: CIK

A (CIK group)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Recurrence

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jin-qing Li, M.D.

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 7, 2008
• First Posted: October 8, 2008
• Study Start: June 1, 2008
• Primary Completion: September 1, 2014
• Study Completion: December 1, 2014
• Last Updated: April 14, 2016

Record last verified: 2015-02

Locations

CN (1)