CIK Treatment for HCC Patient Underwent Radical Resection

Sun Yat-sen University

Status and phase

Completed

Phase 3

Conditions

Carcinoma, Hepatocellular

Treatments

Biological: Cytokine-Induced Killer Cells

Study type

Interventional

Funder types

Other

Identifiers

NCT01749865

2007043-HCC012

Details and patient eligibility

About

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.

Enrollment

200 patients

Sex

All

Ages

18 to 100 years old

Volunteers

No Healthy Volunteers

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: