CIK Treatment for HCC Patient Underwent Radical Resection
Phase 3
Completed
- Conditions
- Carcinoma, Hepatocellular
- Interventions
- Biological: Cytokine-Induced Killer Cells
- Registration Number
- NCT01749865
- Lead Sponsor
- Sun Yat-sen University
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 200
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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description A, CIK Cytokine-Induced Killer Cells Biological/Vaccine: Cytokine-Induced Killer Cells
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Disease Free Survival 5 year Disease Free Survival
Trial Locations
- Locations (1)
Immunotherapy
🇨🇳Guangzhou, Guangdong, China