EBV - associated gastric cancer
Conditions
Interventions
Single-arm:BAT1306 + XELOX
Sponsors
The 81 Hospital of People's Liberation Army
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 75 years, regardless of gender; 2. In patients with pathologically or cytologically confirmed gastric adenocarcinoma (GC) or gastroesophageal junction adenocarcinoma (GEJ), there is evidence of locally advanced lesions or metastases that cannot be resected surgically. Archival tissue that needs formalin fixation or paraffin-embedded or recently collected tumor tissue, or no less than 5 qualified unstained white sheets, shall be sent to the designated central laboratory. If the archived tissue sample is not available, a new biopsy must be performed on the subject prior to treatment; 3. EBERs (EBER-ISH) was diagnosed as EBVaGC by in situ hybridization; 4. No previous systematic treatment for advanced or metastatic GC/GEJ. For patients who have received adjuvant or neoadjuvant treatment (including chemotherapy, radiotherapy and/or chemoradiotherapy) for GC/GEJ in the past, the last treatment must be completed at least 6 months before the first study treatment. Palliative radiotherapy is allowed, but must be completed 2 weeks before the first study treatment. 5. All acute toxicities due to prior medication or surgery were reduced to grade 0-1 (according to NCI CTCAE 5.0) or to the level specified in the enrollment/exclusion criteria. Other toxicities, such as hair loss, that the researchers consider not to pose a safety risk to patients, are excluded. 6. ECOG physical condition score 0-1; 7. The expected survival time is more than 3 months; 8. According to RECIST 1.1, there was at least one measurable tumor lesion; 9. Adequate organ function: Laboratory measurements of organ systems Blood system (no blood transfusion or hematopoietic stimulating factor treatment within 14 days): The absolute value (ANC) of neutrophils was 1.5×10^9/L; Platelet (PLT) 100×10^9/L; Hemoglobin (Hb) 90g/L; Liver function: Total bilirubin (TBIL) 1.5 ULN; Alanine aminotransferase (ALT) 2.5 ULN; Liver metastasis was less than or equal to 5 ULN; Aspartate aminotransferase (AST) 2.5 ULN; Liver metastasis was less than or equal to 5 ULN; Renal function: Creatinine (Cr) 1.5 ULN; Creatinine clearance (CCr) > 50ml/min (by Cockcroft-Gault formula); Blood coagulation function: Activation time of partial thrombin (APTT) was 1.5 ULN; The international standardized ratio (INR) is no more than 1.5 ULN. 10. Fertile eligible patients (male and female) must agree to use a reliable method of contraception (hormonal or barrier or abstinence) during the trial and for at least 6 months after the last dose; The blood pregnancy test must be negative within 7 days before the inclusion of women of childbearing age. 11. Subjects must give informed consent to the study before the test and sign a written informed consent voluntarily.
Exclusion criteria
Exclusion criteria: 1. Patients with positive HER2; 2. Currently participating in the study and receiving the study therapy, or participating in the study of experimental drugs and receiving the study therapy or using the experimental equipment within 4 weeks before the first treatment; 3. Major surgery was performed within 4 weeks before the start of the study and no complete recovery was achieved; 4. Active autoimmune diseases requiring systemic treatment (i.e. the use of disease-relieving drugs, corticosteroids or immunosuppressants, etc.) occurred within 2 years prior to the start of administration. Alternative therapies (such as thyroxine, insulin, or physiological corticosteroid replacement therapy for adrenal or pituitary insufficiency) are not considered systemic; 5. The patient is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose if diagnosed with immunodeficiency or experimental therapy. After consultation with the sponsor, the use of physiological doses of corticosteroids may be approved; 6. Study other malignancies that are known to be progressing or requiring aggressive treatment within 5 years prior to administration. The exceptions are basal cell carcinoma of the skin, squamous cell carcinoma of the skin or carcinoma in situ of the cervix. Note: subjects with basal cell carcinoma of the skin, squamous cell carcinoma of the skin or carcinoma in situ (e.g. 7. Active central nervous system (CNS) metastasis and/or cancerous meningitis are known. Had received a brain metastasis treated subjects to participate in this study, the premise is in stable condition, through repeated imaging examination showed no evidence of progress at least four weeks (note that repeated imaging studies should be performed in the screening period), clinical situation is stable, and the experimental treatment at least 14 days before the first to stop using steroids; 8. A history of pneumonia (non-infectious) requiring steroid treatment within 6 months or currently developing pneumonia (non-infectious). 9. Active infections requiring systemic treatment; 10. If the patient suffers from any other disease, metabolic abnormality, abnormal physical examination or laboratory examination, it is reasonable to suspect that the patient has a certain disease or state that is not suitable for the use of the study drug according to the judgment of the researcher, or it will affect the interpretation of the study results, or put the patient in a high-risk situation; 11. The existence of a known mental or substance abuse disorder that may affect compliance with the test requirements; 12. A history of human immunodeficiency virus (HIV) (HIV 1/2 antibody) infection is known; 13. Known to have active hepatitis b or c. Active hepatitis b was defined as a known positive HBsAg result with hbv-dna > 2000IU/ml. Active hepatitis c was defined as known HCV antibody positive and HCV RNA quantitative results were higher than the detection threshold of the analytical method. Hbv-dna less than 2000IU/ml can be considered for treatment by antiviral therapy. 14. Live vaccines were administered within 30 days prior to the planned start date for the study treatment. A. Note: seasonal influenza vaccine for injection is generally inactivated influenza vaccine, which is allowed to be used; However, intranasal influenza vaccines (such as FluMist) are attenuated live vaccines and will not be used. 15. A history of serious c
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR;DCR;PFS;DOR; | — |
Secondary
| Measure | Time frame |
|---|---|
| immunogenicity;pharmacokinetics;Laboratory examination;Subject baseline;ECOG score;Adverse event evaluation; | — |
Countries
China
Contacts
Public ContactQin Shukui
Outcome results
None listed