gastric cancer, esophageal cancer
Conditions
Interventions
Case series:Vaccination of neoantigen
Sponsors
The First Affiliated Hospital of Zhengzhou University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. The participants should volunteer to participate in this clinical study, sign the informed consents, and be able to follow clinical research protocols and follow-up procedures; 2. Aged 18 to 75 years old (included) males and females; 3. Gastric or esophageal cancer (including gastroesophageal junction cancer) confirmed by histopathology or cytology within the recent 6 months; 4. Patients with stage II/III cancers who can undergo surgery, or patients with Stage IV cancers who have failed multi-line therapy. 5. According to RECIST (V 1.1), there is at least one measurable lesion (i.e., the thickness of spiral CT examination = 10 mm, and the short diameter of malignant lymph nodes >= 15 mm) (except for those with complete resection); 6. ECOG physical status score 0 or 1; 7. Be able to obtain a sufficient amount of fresh or paraffin embedded tumor tissue by biopsy or surgery before treatment (only performed at screening period); 8. Fertile patients must agree to use a reliable contraceptive method (hormonal or barrier method or abstinence) during the trial and at least 12 weeks after the last treatment; 9. Hematological indicators: white blood cell (WBC) count >= 3.0 * 10^9/L without blood transfusion, without treatment with granulocyte colony stimulating factor (G-CSF), and without medication correction within 14 days before screening Absolute value (ALC) >= 0.7 * 10^9/L; absolute neutrophil value (ANC) >= 1.0 * 10^9/L; red blood cells (RBC) >= 2.5 * 10^9 / L; hemoglobin (Hb) >= 90 g/L; platelets count (PLT) >= 80 * 10^9/L (only performed at baseline period); 10. Biochemical indicators: total bilirubin (TBIL) <= 1.5 ULN (upper limits of normal), AST and ALT <= 2.5 ULN (for those with tumor liver metastases, <= 5 ULN), serum creatinine (Cr) <= 1.2 ULN (only performed at baseline period); 11. No CMV, EBV, HIV, HBV, HCV, or syphilis infection (only performed at baseline period).
Exclusion criteria
Exclusion criteria: (1) Allergies or having a history of severe allergic reactions to any anti-infection vaccine; (2) Pregnant or lactating; (3) With an estimated survival of less than 6 months (performed at screening period) or those with an estimated survival of less than 3 months (performed at baseline period); (4) The number of Less than 20 new antigen candidates available for vaccine production according to this process; (5) With untreated brain metastases or symptoms of brain metastases (except for that with stable brain metastases within 4 weeks before enrollment); (6) Existence of extensive lung metastases causing breathing difficulties; (7) Tumor is near or invades large blood vessels or nerves; (8) Having a history of severe cardiovascular or cerebrovascular diseases, including but not limited to, ventricular arrhythmias requiring clinical intervention, acute coronary syndrome within 6 months, myocardial infarction, congestive heart failure, stroke or other grade III or above cardiovascular events, NYHA cardiac function classification over class II or LVEF 150 mmHg, diastolic pressure > 90 mmHg); (9) With active ulcers or gastrointestinal bleeding; (10) With clinically diagnosed autoimmune diseases or CMV, EBV, HIV, HBV, HCV, or syphilis infection; (11) Having a history of organ transplant or being waiting for organ transplant; (12) With active infection; (13) With skin disorders that may prevent subcutaneous vaccination to reach target areas (e.g., psoriasis); (14) Received immunomodulatory medications within 4 weeks before the first vaccination day (D1). These medications include, but are not limited to, IL-2, CTLA-4 inhibitors, PD-1 / PD-L1 inhibitors, CD40 agonists, CD137 agonist, INF-alpha (except for that with high-risk surgery who use INF-alpha as adjuvant treatment but INF-a treatment has been stopped within 4 weeks before this test); (15) Treated with similar personalized tumor vaccines; (16) Participated in other clinical studies within two months before enrollment; (17) Need to use of steroid hormones concomitantly (with cancer or non-cancer-related diseases), exception for topically external application (not applied to the vaccination site) or inhaled steroids; (18) Received anti-tumor treatment such as chemotherapy, radiation therapy, biological therapy, endocrine therapy, and small molecule drug targeted therapy within 4 weeks before D1; (19) Received other non-tumor vaccines against infection, or expected to use other non-tumor vaccines during this tumor vaccination process (if needed, a gap of at least eight weeks is required between the last cancer vaccination and the future application of other vaccines); (20) The adverse effects of previous anti-tumor treatment have not been restored to Grade 1 or lower as to CTCAE v5.0 (except for hair loss); (21) With a known or suspected autoimmune disease, or in an immunosuppressed state, except for the following: vitiligo, type I diabetes, autoimmune-related thyroid function decline requiring hormone replacement therapy, or psoriasis with no requirement of systematic treatments; (22) Having a history of other malignancies, exceptions for the following: 1) disease-free state has lasted at least 5 years and the risk of recurrence risk is low evaluated by the researchers; 2) Carcinoma in situ, basal-cell carcinoma cervical cancer, or skin squamous cell carcinoma Diagnosed and treated in situ and cutaneous
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Specific T lymphocyte responses to neoantigen;CT/MRI examination; | — |
Secondary
| Measure | Time frame |
|---|---|
| Vital signs;routine blood tests;routine urine tests;routine fecal tests;PT, APTT, TT and FIB;metabolic panel in blood;12-lead ECG; | — |
Countries
China
Contacts
Public ContactYi Zhang
The First Affiliated Hospital of Zhengzhou University
Outcome results
None listed