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Study of Cytokine-induced Killer Cell (CIK) Treatment in Patients After Resection of Liver Cancer

Phase 3
Completed
Conditions
Hepatocellular Carcinoma
Interventions
Biological: cytokine-induced killer cell (CIK) treatment
Registration Number
NCT00769106
Lead Sponsor
Sun Yat-sen University
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
200
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
A (CIK group)cytokine-induced killer cell (CIK) treatmentcytokine-induced killer cell treatment plus regular treatment and follow up
Primary Outcome Measures
NameTimeMethod
Time to recurrence (TTR)month
Secondary Outcome Measures
NameTimeMethod
Progression Free Survival (PFS)month
Laboratory findingsevery 3 months
AEs and SAEsmonthly
Overall survival (OS)month

Trial Locations

Locations (1)

Sun Yat-sen University Cancer Center

🇨🇳

Guangzhou, Guangdong, China

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