Gastric Cancer
Conditions
Interventions
RC48+Camrelizumab+S-1:Disitamab Vedotin: 2.5 mg/kg, intravenous drip, Q3W, administered on the first day of each treatment cycle. Camrelizumab: 200 mg/time, intravenous injection, Q3W, administered on
Sponsors
Cancer Hospital Affiliated to Shandong First Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Subjects volunteered to join the study, could complete the signing of the informed consent form, and had good compliance; 2. Aged at least 18 years (when signing the informed consent form), male or female; 3. Gastric cancer or adenocarcinoma of gastroesophageal junction confirmed by histology and/or cytology is diagnosed as cT3-4aN1-3M0 according to AJCC version 8, and cTNM is diagnosed as cT3-4aN1-3M0 according to endoscopic ultrasonography or enhanced CT/MRI scanning (combined with ultrasonic gastroscopy and diagnostic laparoscopic exploration if necessary), and the researcher evaluates that the lesion is resectable; 4. Have not received systematic treatment for current diseases in the past, including surgical treatment, anti-tumor radiochemotherapy/immunotherapy, etc; 5. Patients who agree to receive radical surgical treatment and have no surgical contraindication as judged by the surgeon; 6. IHC results confirmed HER2 expression (defined as IHC2+and 3+); 7. ECOG score 0-1; 8. Expected life = 6 months; 9. The main organs function well and meet the following standards: 1) Blood routine examination (no blood transfusion within 14 days, no use of hematopoietic stimulator drugs for correction): hemoglobin (Hb) = 90g/L; Absolute neutrophil count (ANC) = 1.5 × 109/L Platelet (PLT) = 80 × 109/L 2) Biochemical examination: ALT and AST = 2.5 × ULN (= 5 for patients with liver metastasis × ULN) Total serum bilirubin (TBIL) = 1.5 × ULN (Gilbert syndrome subjects, = 3 × ULN) Serum creatinine (Cr) = 1.5 × ULN, or creatinine clearance = 60mL/min; 3) Coagulation function: activated partial thromboplastin time (APTT), international normalized ratio (INR), prothrombin time (PT) = 1.5 × ULN; 4) Doppler ultrasound evaluation: left ventricular ejection fraction (LVEF) = 50%; 5) Normal thyroid function is defined as thyroid stimulating hormone (TSH) within normal range. If the baseline TSH is beyond the normal range, the subjects whose total T3 (or FT3) and FT4 are within the normal range can also be included in the group; 6) The doctor clinically determines that it has sufficient organ function. 10.The fertile subjects must use appropriate methods of contraception during the study period and within 120 days after the end of the study. The serum pregnancy test was negative within 7 days before the study was included, and they must be non lactating subjects.
Exclusion criteria
Exclusion criteria: 1. Other malignant diseases (excluding skin basal cell carcinoma, skin squamous cell carcinoma, and/or carcinoma in situ after radical resection) diagnosed within 5 years before the first administration; 2. Known endoscopic signs of active hemorrhage of the lesion; 3. Currently participating in the intervention clinical research treatment, or receiving other research drugs or using research instruments within 4 weeks before the first administration; 4. Have received the following therapies in the past: anti HER2, anti PD-1, anti PD-L1 or anti PD-L2 drugs or drugs targeting another kind of stimulation or synergistic inhibition of T cell receptor (including but not limited to CTLA-4, OX-40, CD137, etc.); 5. Within 2 weeks before the first administration, he has received systematic systemic treatment with Chinese patent medicine with anti-tumor indications or drugs with immunomodulatory effects (including thymosin, interferon, interleukin, except for local use to control pleural effusion); 6. Active autoimmune diseases requiring systemic treatment (such as the use of disease relieving drugs, glucocorticoids or immunosuppressants) occurred within 2 years before the first administration. Alternative therapy (such as thyroxine, insulin or physiological glucocorticoid for adrenal or pituitary insufficiency) is not considered as systemic therapy; 7. The study was receiving systemic glucocorticoid treatment (excluding local glucocorticoids by nasal spray, inhalation or other means) or any other form of immunosuppressive therapy within 7 days before the first administration; Note: It is allowed to use glucocorticoid with physiological dose (prednisone = 10 mg/day or equivalent); 8. Known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation; 9. People known to be allergic to the drugs used in this study; 10. Before starting treatment, the patient has not fully recovered from the toxicity and/or complications caused by any intervention (i.e. = Level 1 or reaching the baseline, excluding fatigue or hair loss); 11. Known history of human immunodeficiency virus (HIV) infection (i.e. HIV1/2 antibody positive); 12. Untreated active hepatitis B (defined as HBsAg positive and HBV-DNA copy number detected is greater than the upper limit of normal value in the laboratory of the research center); Note: hepatitis B patients who meet the following criteria can also be included in the group: 1) Before the first administration, if the HBV viral load was less than 1000 copies/ml (200 IU/ml), the subjects should receive anti HBV treatment during the whole study chemotherapy treatment to avoid reactivation of the virus; 2) For subjects with anti HBc (+), HBsAg (-), anti HBs (-) and HBV viral load (-), preventive anti HBV treatment is not required, but virus reactivation needs to be closely monitored. 13. Subjects with active HCV infection (HCV antibody positive and HCV RNA level higher than the lower limit of detection); 14. Live vaccine shall be inoculated within 30 days before the first administration (the first cycle, the first day); Note: It is allowed to receive inactivated virus vaccine for injection against seasonal influenza within 30 days before the first administration; However, live attenuated influenza vaccine administered intranasal is not allowed. 15. Pregnant or lactating women; 16. There are any serious or uncontrollable systemic diseases, such as: 1) There are s
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Major pathological response (MPR) rate;Clinical downgrading rate;Objective response rate (ORR);Disease free survival (DFS);Overall survival (OS); | — |
Primary
| Measure | Time frame |
|---|---|
| Complete pathological response (pCR) rate; | — |
Countries
China
Contacts
Public ContactJie Chai
Cancer Hospital Affiliated to Shandong First Medical University
Outcome results
None listed