Carcinoma, Hepatocellular
Conditions
Brief 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.
Interventions
BIOLOGICALCytokine-Induced Killer Cells
Cytokine-Induced Killer Cells treatment 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 100 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to recurrence | 5-year | To evaluate efficacy of CIK treatment as an adjuvant therapy in patients with hepatocellular carcinoma (HCC) who underwent radical resection. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disease Free Survival | 5 year | Disease Free Survival |
Other
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events | 5 years | To evaluate safety of CIK treatment as an adjuvant therapy in patients with hepatocellular carcinoma (HCC) who underwent radical resection. |
Countries
China
Outcome results
None listed