Adenocarcinoma - GEJ, Adenocarcinoma of the Stomach
Conditions
Brief summary
This is a single-arm, open-label, clinical study to evaluate the safety of HER2 tumor vaccine injection alone/in combination with standard of care chemotherapy in patients with HER2/neu overexpressing gastric or gastroesophageal junction (GEJ) adenocarcinoma. The purpose of this study is to evaluate the safety and tolerability, antitumor activity, The immunoreactivity, pharmacokinetics and of HER2 tumor vaccine.
Interventions
BIOLOGICALHER2 Tumor Vaccine
B-cell epitope vaccine HER2 Tumor Vaccine 0.6 μg，Intramuscular injection on D1, D14 and D28
BIOLOGICALHER2 Tumor Vaccine+ Standard of Care chemotherapy
B-cell epitope vaccine HER2 Tumor Vaccine 0.6 μg，Intramuscular injection on D1, D14 and D28 Standard of Care Chemotherapy cisplatin by intravenous administration at 80 mg/m2 on the first day of each cycle and either 5-FU, 4000 mg/m2 CIV (administered as 1000 mg/m2/day as continuous infusion for 96 hours on days 1 to 4 of each cycle) or capecitabine for 14 days at 2000 mg/m2/day, orally (administered as 1000 mg/m2 twice daily morning and evening for a total of 2000 mg/m2/day on days 1 to 14 of each cycle) or other standard of care chemotherapy
Sponsors
The First Affiliated Hospital of Bengbu Medical University
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female aged ≥ 18 years; * Metastatic gastric or GEJ adenocarcinoma, or locally advanced disease not amenable to surgical resection; * HER2/neu overexpression (3+ by immunohistochemistry (IHC) or if IHC 2+ confirmed by fluorescent in situ hybridization \[FISH\]; * ECOG score of 0 \ 2; * Adequate bone marrow, hepatic and renal and coagulation function; * Women of childbearing age who have a negative pregnancy test within 7 days before treatment. Female patients of childbearing age, and male patients with partners of childbearing age must agree to use at least one medically recognized contraceptive method during study treatment and within at least 6 months after the last dose of investigational drug; * Voluntarily participated in this study, signed the informed；
Exclusion criteria
* Continuous systemic treatment with either corticosteroids (\>10 mg daily prednisone equivalents) or other immunosuppressive medications within 4 weeks prior to first dose of study treatment. Inhaled or topical steroids and physiological replacement doses of up to 10 mg daily prednisone equivalents are permitted in the absence of active auto-immune disease； * Subjects who have had major surgery within 4 weeks before HER2 tumor vaccine administration * Subjects who have received anti-tumor therapy such as chemotherapy, radiotherapy, biological therapy, endocrine therapy, targeted therapy, immunotherapy, etc within 5 elimination half-life prior first dose of HER2 tumor vaccine treatment; * Subjects with known brain metastasis and/or clinically history tumor brain of metastasis； * Patients with uncontrollable pleural effusion, abdominal effusion and pericardial effusion; * Active infection requiring treatment. HIV, HCV, syphilis, CMV, EBV infected patients; Patients with active HBV replication * Other conditions that the investigator assessed as ineligible for inclusion.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of adverse events | Up to 6 months | Graded according to the NCI CTCAE version 5.0. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To evaluate the antitumor activity | Up to 2 years | To assess per RECIST and iRECIST |
| Humoral and cellular immunogenicity of HER2 Tumor Vaccine | Up to 6 months | Values and changes from randomization in humoral and cellular immunogenicity data including P467-specific antibodies (IgG), Her-2-specific antibodies (IgG), vaccine-specific cytokine levels and regulatory and effector T and B cells. |
Countries
China
Contacts
Primary ContactHuan Zhou, MD
Outcome results
None listed