CIK Treatment for HCC Patient Underwent Radical Resection

Carcinoma, Hepatocellular Clinical Trial

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: NCT01749865
• Other study ID #: 2007043-HCC012
• Status: Completed
• Phase: Phase 3
• First received: December 12, 2012
• Last updated: April 13, 2016
• Start date: October 2008
• Est. completion date: December 2014

Study information

• Verified date: April 2016
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sun Yat-sen University: China
• Study type: Interventional

Clinical Trial 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.

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 to 100 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular

Intervention

Biological:
• Cytokine-Induced Killer Cells
Cytokine-Induced Killer Cells treatment for 4 cycles

Locations

Country	Name	City	State
China	Immunotherapy	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
Other	Adverse Events	To evaluate safety of CIK treatment as an adjuvant therapy in patients with hepatocellular carcinoma (HCC) who underwent radical resection.	5 years	Yes
Primary	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	No
Secondary	Disease Free Survival	Disease Free Survival	5 year	No