Autologous Immune Cell Therapy in Primary Hepatocellular Carcinoma Patients Following Resection and TACE Therapy (DC-TC)
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ClinicalTrials.gov Identifier: NCT01828762 |
Recruitment Status :
Completed
First Posted : April 11, 2013
Last Update Posted : December 23, 2013
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Primary Hepatocellular Carcinoma | Biological: DC-TC+GM-CSF | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 8 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Clinical Study of the Safety of Autologous Immune Cell Therapy in Primary Hepatocellular Carcinoma Patients Following Resection and TACE Therapy |
Study Start Date : | December 2012 |
Actual Primary Completion Date : | December 2013 |
Arm | Intervention/treatment |
---|---|
Experimental: DC-TC+GM-CSF |
Biological: DC-TC+GM-CSF |
- Vital signs,physical examinations and adverse events [ Time Frame: one year ]The number of adverse events along with the results of vital signs measurements, physical examinations, and clinical laboratory tests will be used to determine the safety profile of DC-TC.

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Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Voluntary written informed consent signed by patient or legal guardian, obtained prior to study enrollment.
- BCLC Classification A-B
- Patients who are good surgical candidates for HCC resection
- ECOG Performance Score, 0-1
- Child-Pugh Rating, A
- Expected survival greater than 6 months
Exclusion Criteria:
- History of anaphylactic reaction to GM-CSF
- Congestive heart failure, unstable angina or other underlying cardiac disease; history of thrombosis currently requiring anticoagulation
- Mental or psychological illness preventing cooperation with treatment, efficacy evaluations, or unable to understand the informed consent process
- Primary cancers of any kind or location, other than hepatocellular carcinoma
- Excluding hepatitis, any active or unresolved infection including HIV, EBV, CMV, RPR, TB, etc.
- Autoimmune disease requiring therapy; immunodeficiency, or any disease process requiring immunosuppressive therapy.
- Prior clinical trial requiring patient to receive an investigational drug within two weeks of enrollment.
- Pregnant or lactating women.
- Patients with the intention to receive transplantation
- 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.
- Evidence of metastatic disease.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01828762
China, Shanghai | |
9585 Humin Road,Xuhui district | |
Shanghai, Shanghai, China, 200235 |
Principal Investigator: | Chengwei Chen | No.85 Hospital, Changning, Shanghai, China |
Responsible Party: | Cellular Biomedicine Group Ltd. |
ClinicalTrials.gov Identifier: | NCT01828762 |
Other Study ID Numbers: |
040420100005 |
First Posted: | April 11, 2013 Key Record Dates |
Last Update Posted: | December 23, 2013 |
Last Verified: | April 2013 |
DC Immunotherapy TC |
Carcinoma Carcinoma, Hepatocellular Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Adenocarcinoma |
Liver Neoplasms Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Liver Diseases |