Hepatocellular Carcinoma Clinical Trial
Official title:
A Study of Adoptive Invariant Nature Killer T Cell Therapy for Relapsed/Advanced Hepatocellular Carcinoma (HCC)
This study enrolls patients who have relapsed/advanced hepatocellular carcinoma (HCC, BCLC
stage C). The HCC tumor relapsed or metastasized through the body after standard treatment or
the patients cannot receive standard treatment under current conditions. This research study
uses special immune system cells called iNKT cells, a new experimental treatment.
The purpose of this study is to find the biggest dose of iNKT cells that is safe and
tolerance, to see how long they last in the body, to learn the immunoresponse in the body, to
learn the side effects are and to see if the iNKT cells will help people with
relapsed/advanced hepatocellular carcinoma (HCC).
Status | Recruiting |
Enrollment | 18 |
Est. completion date | March 30, 2019 |
Est. primary completion date | December 30, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: - Age 18-80 years. - Patients with hepatocellular carcinoma (BCLC, stage C) proved by histopathology or proved by CT or MRI imaging system, relapsed after previous therapy and no effective therapies known at this time. - Life expectancy of = 12 weeks. - WBC>3.5×10^9/L, LYMPH> 0.8×10^9/L, Hb>85g/L, PLT>50×10^9/L, Cre<1.5×the upper limit of normal value. - iNKT>10/mL in peripheral blood mononuclear cell (PBMC). - Able to understand and sign the informed consent. Exclusion Criteria: - Any uncontrolled systematic disease: hypertension, heart disease, and et al.; - Portal vein tumor thrombus, central nervous system tumor metastasis, or combined with other tumors; - Receiving radiochemotherapy, local therapy, or targeting drugs within 4 weeks prior to this treatment; - Unstable immune systematic diseases or infectious diseases; - Combined with AIDS or syphilis; - Patients with history of stem cell or organ transplantation; - Patients with allergic history to related drugs and immunotherapy; - Patients with complications associated with liver diseases: moderate or severe pleural effusion, pericardial effusion, ascites, or gastrointestinal hemorrhage; - Pregnant or lactating subjects; - Unsuitable subjects considered by clinicians. |
Country | Name | City | State |
---|---|---|---|
China | Beijing Youan Hospital,Capital Medical University | Beijing | Beijing |
Lead Sponsor | Collaborator |
---|---|
Beijing YouAn Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Progression-Free Survival (PFS) | PFS is the time that passes from the date that patient enrolled in the clinical trial and the date on which HCC progresses or the date on which the patient dies. HCC progression was evaluated by imaging according to the irRC standard. | 12 weeks or up to death | |
Other | Disease Control Rate (DCR) | DCR is the proportion of patients who had a response rate including complete remission (CR), partial remission (PR) and disease stabilization (SD) evaluated by imaging according to the irRC standard. | 12 weeks or up to death | |
Primary | Incidence of Treatment-Emergent Adverse Events [Safety] | Defined as signs/symptoms, laboratory toxicities, and clinical events that are possibly, likely, or definitely related to study treatment Adverse events assessed according to NCI-CTCAE v4.0 criteria 2. | 4 weeks | |
Secondary | Biological activity of infused iNKT cells | To assess the biological activity of infused in vitro expanded autologous iNKT cells in conjunction with IL-2. | 4 weeks |
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