A Study of DC-CIK to Treat Hepatocellular Carcinoma
A Randomized Controlled Study of Dendritic and Cytokine-induced Killer Cells (DC-CIK) Treatment in Patients With Hepatocellular Carcinoma
1 other identifier
interventional
100
1 country
1
Brief Summary
The purpose of this study is to evaluate the efficacy of Dendritic and Cytokine-induced Killer Cells (DC-CIK) for hepatocellular carcinoma (HCC).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started May 2013
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 27, 2013
CompletedFirst Posted
Study publicly available on registry
April 1, 2013
CompletedStudy Start
First participant enrolled
May 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2018
CompletedApril 12, 2013
April 1, 2013
5 years
March 27, 2013
April 11, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
progression-free survival(PFS)
1 month
Secondary Outcomes (2)
Overall survival(OS)
1 month
quality of life (QOL)
month
Other Outcomes (1)
Laboratory findings
1 month
Study Arms (2)
A
EXPERIMENTALAfter complete resection or TACE, patients will receive 3 cycles of Dendritic and Cytokine-induced Killer Cells (DC-CIK) (every 4 weeks)
B
NO INTERVENTIONAfter complete resection or TACE, Patient only regularly follow up
Interventions
Eligibility Criteria
You may qualify if:
- Male or female patients \> 18 years of age;
- Hepatocellular carcinoma with histological or imaging and AFP diagnose, and had received complete resection or TACE and got CR or PR by imaging studies;
- Patients who have a life expectancy of at least 12 weeks;
- Eastern Cooperative Oncology Group (ECOG) performance status was 0 - 1;
- The bone marrow functioned normally (WBC \> 4.0×109/L, Hb \> 120 g/L, PLT \> 100×109/L);
- The ECG results were normal, and the liver and kidney were functional.
You may not qualify if:
- Patients who had distant metastases;
- Patients with uncontrolled infection; underlying disease that was severe or life-threatening;
- Patients who were pregnant or lactating;
- ECOG perform status ≥ 2;
- Patients who are suffering from auto immune diseases or patients who need to accept glucocorticoid treatment.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The first Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, 530000, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Hanfeng Liu
Guangxi Medical University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Investigator
Study Record Dates
First Submitted
March 27, 2013
First Posted
April 1, 2013
Study Start
May 1, 2013
Primary Completion
May 1, 2018
Study Completion
May 1, 2018
Last Updated
April 12, 2013
Record last verified: 2013-04