Hepatocellular Carcinoma
Conditions
Brief summary
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 specific HCC antigens CD8+ T cells, a new experimental treatment. The purpose of this study is to evaluate the safety and tolerance as well as the potential clinical efficacy of an adoptive transfer of CD8+ T cells, sorted with human leukocyte antigen (HLA)-peptide multimers and specific for Glypican (GPC)-3 /New York Esophageal Squamous-1 (NY-ESO-1) /alpha-fetoprotein (AFP) antigens and cultured in vitro, to patients suffering from relapsed/advanced hepatocellular carcinoma (HCC).
Interventions
BIOLOGICALHCC antigens-specific CD8+ T lymphocytes
Three different dosing schedules will be evaluated. Three patients will be evaluated on each dosing schedule. The following dose levels will be evaluated: Loading Dose 1: 3x10\^7/m2 Loading Dose 2: 6x10\^7/m2 Loading Dose 3: 9x10\^7/m2 The doses are calculated according to the actual number of GPC3/NY-ESO-1/AFP specific cytotoxic lymphocytes (CTLs)
DRUGIL-2
IL-2 will be given at a dose of 25000 IU/kg/day for 5-14 days.
DRUGTegafur
Tegafur will be given at a dose of 40\ 60 mg bis in die (BID) 2 weeks.
Sponsors
Beijing YouAn Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Age 18-80 years * Patients with relapsed/advanced HCC (BCLC, stage C) proved by histopathology or proved by CT or MRI imaging system, proven GPC3/NY-ESO-1/AFP(+), 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. * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events [Safety] | 4 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Biological activity of infused T cells | 4 weeks | To assess the biological activity of infused in vitro expanded and sorted HCC antigens-specific T cells. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Progress Free Survival (PFS) | 12 weeks or up to death | 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. |
| Disease Control Rate (DCR) | 12 weeks or up to death | 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. |
Countries
China
Contacts
Primary ContactJun Lu, Director
Backup ContactXuli Bao, Clinician
Outcome results
None listed