Gastric or Esophagogastric Junction Cancer
Conditions
Interventions
Experimental group:Neoadjuvant Treatment with Iparomlimab and Tuvonralimab
Sponsors
Sun Yat-sen University Cancer Center
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. The subjects voluntarily joined the study and signed the informed consent; 2. No gender limitation, age 18-75 years old; 3. ECOG 0-1; 4. weight >30kg; 5. The patient was histologically confirmed as gastric or esophagogastric junction cancer and MSI-H/dMMR was confirmed by biopsy pathology; 6. Initial treatment of stage cT1b-3, any cN, M0 or cT1aN+M0 (limited AJCC TNM stage 8th edition, see Annex 3) gastric or esophagogastric junction cancerthat can be resectable by imaging evaluation (enhanced CT or enhanced MRI or endoscopic ultrasound or pet-ct); 7. Non-Borrmann type 4; 8. Laparoscopic Exploration: No evidence of linitis plastica, tumor did not infiltrate the serosa or invade adjacent organs, no peritoneal metastasis, and ascites is absent. 9. Expected survival: = 6 months. 10. Vital organ function meets the following requirements (1) Absolute neutrophil count (ANC) >=1.5×109/L; Platelet >=75×10^9/L; Hemoglobin >=6g/dL; (2) Liver function: serum albumin >=28/L; Bilirubin =50 ml/min (using Cockcroft-Gault formula; (4) Coagulation function: International Normalized Ratio (INR) <=1.5, Activated partial thromboplastin time (APTT) <=1.5×ULN; 11. Female subjects of childbearing age or male subjects whose partners are women of childbearing age are required to take effective contraceptive measures throughout the treatment period and for 6 months after the treatment period. Evidence of postmenopausal status in female subjects, or negative urine or serum pregnancy test results in premenopausal female subjects.
Exclusion criteria
Exclusion criteria: 1. Patients with any active autoimmune diseases or history of autoimmune diseases (including but not limited to hepatitis, interstitial pneumonia, uveitis, enteritis, hypophysitis, nephritis, hyperthyroidism, hypothyroidism; patients with vitiligo or those with asthma who have had a complete response in childhood and do not require any intervention after adulthood can be included; but those with asthma requiring medical intervention with a bronchodilator should be excluded). 2. Having comorbidities requiring chronic therapy with immunosuppressive drugs or systemic or topical corticosteroids at immunosuppressive doses (> 10 mg/day of prednisone or other equivalent steroids). 3. Known or suspected allergy to the study drug or allergic to any study related drug administered. 4. With history of having any other PD-1 or PD-L1 inhibitors or anti-angiogenic agents. 5. Having arrhythmia that requires anti-arrhythmic therapy (except beta-blockers or digoxin), symptomatic coronary artery diseases or local myocardial ischemia (myocardial infarction within the last 6 months), or congestive heart failure exceeding NYHA Class II-IV. 6. With genetic or acquired bleeding and thrombotic tendencies (such as hemophilia, coagulation disorders, thrombocytopenia, splenomegaly) or receiving thrombolytic or anticoagulant therapy. 7. Urine protein >= ++ or 24-hour urine protein excretion >= 1.0 g. 8. With significant clinically significant bleeding symptoms or had a clear bleeding tendency, such as gastrointestinal bleeding, active bleeding, baseline fecal occult blood test (++ or above), or diagnosed with vasculitis, within 3 months prior to enrollment. 9. With arterial or venous thrombotic events within 6 months prior to enrollment, such as cerebrovascular accidents (including transient ischemic attacks, cerebral hemorrhage, and cerebral infarction), deep vein thrombosis, and pulmonary embolism. 10. With other active and clinically significant infections. 11. With a history of HIV infection or active chronic hepatitis B or C (hepatitis B: HBsAg positive and HBV DNA >=104 copies/ml; hepatitis C: HCV Ab positive.); 12. Have participated in other clinical trials of medications within 1 month prior to enrollment. 13. With evidence of distant metastasis outside the pelvic cavity pre-operatively. 14. With history of other malignancy within the past 5 years, except cured in situ carcinoma of the cervix or basal cell carcinoma of the skin. 15. Having received any anti-infection vaccine (e.g., influenza vaccine, chickenpox vaccine) within 4 weeks prior to enrollment. 16. Known or suspected allergy to the study drug or allergic to any study related drug administered. 17. Patient who has other conditions or factors that could potentially affect the study outcomes or lead to premature termination of the study, such as substance abuse, severe diseases (including psychiatric conditions such as seizures), and other medical, psychological, or social conditions that may compromise patient safety or compliance in the opinion of the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 2-year Complete Response rate;Pathological Complete Response;Clinical Complete Response; | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse event;Overall survival;R0 resection rate; | — |
Countries
China
Contacts
Public ContactHaibo Qiu
Sun Yat-sen University Cancer Center
Outcome results
None listed