Clinical trial NCT01828762: Autologous Immune Cell Therapy in Primary Hepatocellular Carcinoma Patients Following Resection and TACE Therapy
Official title: Clinical Study of the Safety of Autologous Immune Cell Therapy in Primary Hepatocellular Carcinoma Patients Following Resection and TACE Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Primary Hepatocellular Carcinoma
Keywords: DC
Immunotherapy
TC
Lead sponsor: Shanghai AbelZeta Ltd.
Sponsor class: INDUSTRY
Collaborators: name: No.85 Hospital, Changning, Shanghai, China
name: China Cell Technology Ltd.
First posted: 2013-04-11
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Although liver resection, liver transplantation, a-interferon, Transarterial Chemo Embolization (TACE), percutaneous ethanol injection (PEI), Percutaneous microwave coagulation therapy (PMCT), Radiofrequency ablation (RFA) provide options to treat patients with HCC, the high recurrence rate of mid-late stage liver cancer still exists. The safety of autologous Immune Cell Therapy in Primary Hepatocellular Carcinoma (HCC) Patients Following Resection and TACE Therapy will be evaluated.

Detailed description: The study is a single center,open label trial. To obtain safety information on toxicities and adverse events attributable to the subcutaneous injections of autologous dendritic cells incubated with irradiated autologous tumor stem cells and suspended in GM-CSF in patients with HCC.

Eligibility criteria: Inclusion Criteria:

1. Voluntary written informed consent signed by patient or legal guardian, obtained prior to study enrollment.
2. BCLC Classification A-B
3. Patients who are good surgical candidates for HCC resection
4. ECOG Performance Score, 0-1
5. Child-Pugh Rating, A
6. Expected survival greater than 6 months

Exclusion Criteria:

1. History of anaphylactic reaction to GM-CSF
2. Congestive heart failure, unstable angina or other underlying cardiac disease; history of thrombosis currently requiring anticoagulation
3. Mental or psychological illness preventing cooperation with treatment, efficacy evaluations, or unable to understand the informed consent process
4. Primary cancers of any kind or location, other than hepatocellular carcinoma
5. Excluding hepatitis, any active or unresolved infection including HIV, EBV, CMV, RPR, TB, etc.
6. Autoimmune disease requiring therapy; immunodeficiency, or any disease process requiring immunosuppressive therapy.
7. Prior clinical trial requiring patient to receive an investigational drug within two weeks of enrollment.
8. Pregnant or lactating women.
9. Patients with the intention to receive transplantation
10. Significant comorbidity or other active medical condition that could be eminently life threatening in the opinion of the investigator, including no active blood clotting or bleeding diathesis.
11. Evidence of metastatic disease.

Primary outcomes:
measure: Vital signs，physical examinations and adverse events
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: 9585 Humin Road,Xuhui district
state: Shanghai
Study officials:
affiliation: No.85 Hospital, Changning, Shanghai, China
name: Chengwei Chen
role: PRINCIPAL_INVESTIGATOR
References: