Hepatocellular Carcinoma
Conditions
Keywords
hepatocellular carcinoma, recurrent, cytokine-induced killer cell
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.
Interventions
BIOLOGICALcytokine-induced killer cell (CIK) treatment
cytokine-induced killer cell treatment every two weeks, for 4 cycles
Sponsors
Sun Yat-sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to recurrence (TTR) | month |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival (OS) | month |
| Progression Free Survival (PFS) | month |
| Laboratory findings | every 3 months |
| AEs and SAEs | monthly |
Countries
China
Outcome results
None listed