Adenocarcinoma of the stomach and gastroesophageal junction
Conditions
Interventions
Experimental Group:Ivoximab monoclonal antibody: 20 mg / kg, i.v., d1, q3w
Chemotherapy regimen:
Oxaliplatin 130 mg / m^2 i.v., d1, q3w
Tessio:
The body surface area was more than 1.5 m^2, and the dose of TEG was 60 mg bid d 1-14, q3w
The body surface area was less than 1.25 m^2, and the dose of TEG was 40mg bid d 1-14, q3w
The body surface area was 1.25 m^2 -1.5m^2, and the dose of TEG was 50mg bid d-1-14, q3w
Sponsors
Xiamen Hospital Affiliated to Zhongshan Hospital, Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Before implementing any trial-related procedures, sign a written informed consent. 2. Male or female, aged = 18 years old; 3. Locally advanced gastric adenocarcinoma or adenocarcinoma of the gastroesophageal junction confirmed by histopathological examination 4. Has not received any systemic treatment for the current disease in the past, including surgical treatment, anti-tumor radiotherapy and chemotherapy/immunotherapy, etc. 5. According to RECIST v1.1 version, there is at least one measurable lesion or evaluable lesion; 6.ECOG score: 0-1 point; 7. Expected survival time >6 months; 8. Sufficient organ function. The subjects need to meet the following laboratory indicators: In the absence of granulocyte colony-stimulating factor for the past 14 days, the absolute value of neutrophils (ANC) is greater than or equal to 1.5 × 10^9/L. 2) Without blood transfusion in the past 14 days, the platelet count should be greater than or equal to 100×10^9/L. 3) In the past 14 days, without blood transfusion or the use of erythropoietin, the hemoglobin level is greater than 90g/L. 4) Total bilirubin =60 ml/min; 7) Good coagulation function, defined as an international normalized ratio (INR) or prothrombin time (PT) <=1.5 times ULN; 8) Normal thyroid function is defined as thyroid stimulating hormone (TSH) within the normal range. If the baseline TSH exceeds the normal range, subjects with total T3 (or FT3) and FT4 within the normal range can also be enrolled. 9) The myocardial enzyme spectrum is within the normal range (if the researcher comprehensively determines that it is a simple laboratory abnormality without clinical significance, enrollment is also allowed). For female subjects of childbearing age, a urine or serum pregnancy test should be conducted within 3 days prior to the first administration of the study drug (Day 1 of cycle 1), and the result should be negative. If the result of the urine pregnancy test cannot be confirmed as negative, a blood pregnancy test is required. Women of non-childbearing age are defined as those who have been menopausal for at least one year, or have undergone surgical sterilization or hysterectomy. 10. If there is a risk of conception, all subjects (regardless of gender) are required to use contraceptive measures with an annual failure rate of less than 1% throughout the treatment period until 120 days after the last administration of the study drug (or 180 days after the last administration of the chemotherapy drug).
Exclusion criteria
Exclusion criteria: 1. Diagnosis of a malignant disease other than stomach cancer within 5 years prior to first administration (excluding cured basal cell carcinoma, squamous epithelial carcinoma of the skin, and / or cured in situ cancer); 2. Imaging during screening showed that the tumor surrounded important blood vessels or had a significant necrosis or void, and the researchers determined that admission to the study caused a risk of bleeding; 3. A near obstruction of the ventricles and hesophagus affects the patient's eating and emptying of the stomach, or has an impairment in swallowing pills; 4. Systemic systemic treatment with Traditional Chinese Medicine Patent Prescription or immunoregulatory drugs (including thymosin, interferon, interleukin, except for local use to control pleural effusion) within 2 weeks prior to the first administration; 5. Active autoimmune disease requiring systemic treatment (such as the use of disease-relieving drugs, corticosteroids, or immunosuppressants) occurred within 2 years prior to the initial administration. Replacement therapies (such as thyroid hormones, insulins, or physiologic glucocorticoids for adrenal gland or pituitary insufficiency) are not considered systemic; 6. They were receiving systemic corticosteroid therapy (excluding nasal, inhaled or otherwise topical corticosteroids) or any other form of immunosuppressive therapy within 7 days prior to the study's initial administration; Note: Physiological doses of glucocorticoids (<= 10 mg / day of prednisone or equivalent) are permitted; 7. It is known that heterologous organ transplants (except for corneal transplants) or heterologous hematopoietic stem cell transplants are performed; 8. Persons known to be allergic to the drug used in this study; 9. People with a variety of factors that affect thiago (such as inability to swallow and bowel obstruction); 10.Have not fully recovered from the toxicity and / or complications caused by any intervention before starting treatment (i.e., = grade 1 or reached baseline, excluding fatigue or hair loss); 11. Known history of human immunodeficiency virus (HIV) infection (i.e. HIV1 / 2 antibody positive); 12. Untreated chronic hepatitis B (defined as positive HBsAg and detection of HBV-DNA copies greater than the lower limit of the laboratory normal at the research center); Note: Hepatitis B subjects who meet the following criteria are also eligible for inclusion: 1) With HBV viral load < 500 IU / ml before first administration, subjects should receive anti-HBV therapy throughout the study to avoid viral reactivation 2) For subjects with anti-HBc (+), HBsAg (-), anti-HBs (-), and HBV viral load (-), preventive anti-HBV therapy is required 13. Subjects with active HCV infection (HCV antibody positive and HCV-RNA levels above the lower detection limit); 14. Vaccinated live within 30 days prior to the first dose (cycle 1, day 1); Note: Immunization of the inactivated virus vaccine against seasonal influenza is permitted within 30 days prior to the first dose; But you're not allowed to receive a poison-reducing live influenza vaccine that's administered in the nose. 15. Women who are pregnant or breastfeeding; 16. The presence of any systemic disease that is severe or uncontrollable, such as: 1) Significant and uncontrollable abnormalities in rhythm, conduction or morphology on resting electrocardiogram, such as complete left bundle branch block, second degree or above heart block, ventricular arrhythmias or atrial fibrilla
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathologic Complete Remission;Overall Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Major Pathological Response;Downstaging;Rate of R0 resection;Disease-free survival; | — |
Countries
China
Contacts
Public ContactShen Feng
Xiamen Hospital Affiliated to Zhongshan Hospital, Fudan University
Outcome results
None listed