Gastric cancer
Conditions
Interventions
Sponsors
Sichuan Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Age: 18-75 years old, regardless of gender; 2.There are gastric cancer or gastroesophageal junction (GEJ) cancers that have been histologically confirmed and have not received treatment, and histological examination confirms that they are mainly adenocarcinoma. Gastroesophageal junction (GEJ) cancer only allows Siewert type III and Siewert type II subjects who do not require combined thoracotomy surgery to be enrolled; 3.Before treatment, local advanced gastric/gastroesophageal junction adenocarcinoma with large volume Borrmann III, Borrmann IV, and Bulky lymph nodes was identified using gastroscopy, CT, MRI, or PET-CT; 4.The pathological IHC results before treatment indicate HER2 expression (IHC 1+, 2+, 3+); Simultaneously, laparoscopic exploration confirmed no abdominal implant metastasis (CY1/P1); 5.Has not received prior treatment (radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc.); 6.ECOG:0-1; 7.The time from the end of traditional Chinese medicine, traditional Chinese patent medicines and simple preparations and immunomodulator (such as thymosin, lentinan, interleukin-12, etc.) that have used anti-tumor drugs in the past to the start of the study must be >= 2 weeks; 8.Normal main organ function, i.e. meeting the following criteria (no blood transfusion, albumin, recombinant human thrombopoietin or colony stimulating factor (CSF) treatment received within 14 days prior to enrollment):; 9.Before enrollment, the heart function was good, and there were no myocardial infarction attacks within six months. Hypertension and other coronary heart diseases are currently within controllable range; 10.Before enrollment, there were no other uncontrollable benign diseases such as lung, kidney, liver infections, etc; 11.Female patients must meet: Menopausal (defined as having no menstruation for at least 1 year and no confirmed cause other than menopause), or having undergone surgical sterilization (removal of ovaries and/or uterus), or having fertility, must meet the following requirements simultaneously: 1) The serum pregnancy test results within 7 days before enrollment must be negative; 2) Agree to use contraceptive measures with an annual failure rate of less than 1% or maintain abstinence (to avoid heterosexual intercourse) (from signing the informed consent form to at least 120 days after the last administration of the investigational drug, and at least 6 months after the last administration of chemotherapy drugs (contraceptive methods with an annual failure rate of less than 1% include bilateral tubal ligation, male sterilization, correct use of hormonal contraceptives that can inhibit ovulation, hormone releasing intrauterine devices, and copper containing intrauterine devices) 3) Do not breastfeed. Male patients must meet: Agree to abstinence (to avoid heterosexual intercourse) or use contraceptive measures. The contraceptive measures are as follows: when the partner is a woman of childbearing age or the partner is pregnant, male patients must maintain abstinence or use condoms correctly for at least 120 days after the last dose of the investigational drug during chemotherapy treatment and at least 6 months after the last dose of the chemotherapy drug to prevent drug exposure to the embryo. The reliability of sexual abstinence should be evaluated based on the duration of clinical research, patient preferences, and daily lifestyle. Regular abstinence (such as calendar days, ovulation period, basal body temperature, or p
Exclusion criteria
Exclusion criteria: 1.Diagnosed as malignant diseases other than gastric cancer within 5 years prior to initial administration (excluding curative basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and/or curative resection of carcinoma in situ); 2.The tumor lesion has a tendency for bleeding (such as the presence of active ulcer tumor lesions with positive fecal occult blood test, history of vomiting blood or black stools within 2 months before signing the informed consent form, and a risk of gastrointestinal bleeding determined by the researcher), or has received blood transfusion treatment 4 weeks before the study medication; 3.Unable to take medication orally; 4.Currently participating in intervention clinical research treatment, or having received other research drugs or used research instruments within 4 weeks prior to the first administration; 5.Previously received the following therapies: anti-HER2, anti-PD-1, anti-PD-L1 drugs, anti-PD-L2 drugs, or drugs targeting another stimulus or synergistic inhibition of T cell receptors (including but not limited to CTLA-4, OX-40, CD137, etc.); 6.Within 2 weeks before the first administration, he has received systematic systemic treatment with traditional Chinese patent medicines and simple preparations with anti-tumor indications or drugs with immunomodulatory effects (including thymosin, interferon, interleukin, except for local use to control pleural effusion); 7.Active autoimmune diseases that require systemic treatment (such as the use of disease relieving drugs, glucocorticoids, or immunosuppressants) have occurred within 2 years prior to the first administration. Alternative therapies (such as thyroid hormone, insulin, or physiological glucocorticoids used for adrenal or pituitary insufficiency) are not considered systemic treatments; 8.Within 7 days prior to the first administration of the study, the patient is undergoing systemic glucocorticoid therapy (excluding local glucocorticoids administered through nasal spray, inhalation, or other routes) or any other form of immunosuppressive therapy; Note: Physiological doses of glucocorticoids (= grade 2; 12.Known history of human immunodeficiency virus (HIV) infection (i.e. HIV 1/2 antibody positive); 13.Active hepatitis B or hepatitis C subjects (HBsAg positive with HBV DNA titers higher than the upper limit of normal; HCVAb positive with HCV RNA titers higher than the upper limit of normal); 14.Received live vaccine within 30 days before the first administration (1st cycle, 1st day); 15.Pregnant or lactating women; 16.There are any serious or uncontrollable systemic diseases, such as: 1) Resting electrocardiogram shows significant and difficult to control abnormalities in rhythm, conduction, or morphology, such as complete left bundle branch block, second degree or above cardiac block, ventricular arrhythmias, or atrial fibrillation; 2) Unstable angina, congestive heart failure, and chronic heart failure with a New York Heart Association (NYHA) rating of >= 2; 3) Has experienced any arterial thrombosis, embolism, or ischemia within the 6 months prior to being selected for treatment, such as myocardial infarction, unstable angina, cerebr
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| MPR;adverse event; | — |
Secondary
| Measure | Time frame |
|---|---|
| operative mortality;hospital stay;Serious adverse event;Incidence of surgical complications;readmission rate; | — |
Countries
China
Contacts
Public ContactXiao Shuomeng
Sichuan Cancer Hospital
Outcome results
None listed