Status:
COMPLETED
Study of Cytokine-induced Killer Cell (CIK) Treatment in Patients After Resection of Liver Cancer
Lead Sponsor:
Sun Yat-sen University
Conditions:
Hepatocellular Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT00769106
Start Date
June 1 2008
End Date
December 1 2014
Last Update
April 14 2016
Active Locations (1)
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1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060