Gastric or Gastroesophageal Junction Adenocarcinoma
Conditions
Interventions
Treatment group:20-25 Gy/5f Short-Course Radiotherapy Followed by Sequential Iparomlimab and Tuvonralimab Combined with SOX Chemotherapy Regimen (S-1 + Oxaliplatin)
Sponsors
Shandong First Medical University and Shandong Academy of Medical Sciences (Shandong Cancer Hospital &Institute)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age: 18 to 75 years old; both males and females are eligible. 2. Patients with gastric or gastroesophageal junction adenocarcinoma confirmed by histology or cytology; 3. Definition of resectable gastric cancer in this study: Advanced gastric cancer with clinical stage ? and ?, defined by the clinical TNM staging of cT2 to cT4a, N+, M0; 4. Per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1), patients must have at least one measurable lesion; 5. Performance Status (PS) Score: 0 to 1; 6. Good function of major organs, with laboratory test results meeting the following criteria: (1) Hematology: Absolute Neutrophil Count (ANC) >= 1.5 × 10?/L (or above the lower limit of normal [LLN] of the study center's laboratory); Platelet Count (PLT) >= 100 × 10?/L; Hemoglobin (Hb) = 90 g/L. (2) Liver Function: Serum Total Bilirubin (TBIL) = 60 ml/min/1.73m² (calculated by the Cockcroft-Gault formula). 7. Female subjects of childbearing potential, as well as male subjects whose partners are females of childbearing potential, must use a medically approved contraceptive method during the study treatment period and within 6 months after the end of treatment. 8. Must voluntarily agree to participate in this study, sign the informed consent form, have good compliance, and cooperate with follow-up.
Exclusion criteria
Exclusion criteria: 1. Presence of uncontrollable pleural effusion, pericardial effusion, or peritoneal effusion requiring repeated drainage; 2. History of previous allergy to any of the components of Iparomlimab and Tuvonralimab, S-1, Oxaliplatin, or other relevant drugs; 3. Having received any of the following treatments: a. Having received any other investigational drugs within 4 weeks prior to the first administration of the study drug, or within 5 half-lives of the last dose of any other investigational drug; b. Being concurrently enrolled in another clinical study, unless it is an observational (non-interventional) clinical study or the follow-up phase of an interventional clinical study; c. Having received anti-tumor treatment (including radiotherapy, chemotherapy, immunotherapy, endocrine therapy, targeted therapy, anti-tumor traditional Chinese medicine therapy, biological therapy, or tumor embolization) within 2 weeks prior to the first administration of the study drug; d. Subjects requiring administration of corticosteroids (>10 mg per day of prednisone equivalent dose) within 2 weeks prior to the first administration of the study drug. Routine corticosteroid use for chemotherapy premedication is permitted without dose adjustment. Other special cases need to be discussed with the investigator. In the absence of active autoimmune disease, inhaled or topical corticosteroids and adrenal cortical hormone replacement with a dose exceeding 10 mg/day of prednisone equivalent are permitted; e. Having received an anti-tumor vaccine, or having received a live vaccine within 4 weeks prior to the first administration of the study drug; f. Having undergone major surgery or suffered severe trauma within 4 weeks prior to the first administration of the study drug; 4. Active autoimmune disease or a history of autoimmune disease (including but not limited to interstitial pneumonia, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism, or other such diseases/syndromes); excluding the following patients: Patients with vitiligo, or cured childhood asthma/allergies that require no intervention in adulthood; Patients with autoimmune-mediated hypothyroidism treated with a stable dose of thyroid hormone replacement; Patients with Type 1 diabetes mellitus managed with a stable dose of insulin. 5. History of immunodeficiency, including positive HIV test result, or having other acquired or congenital immunodeficiency diseases, or history of organ transplantation or allogeneic bone marrow transplantation, or active hepatitis (for hepatitis B reference: HBV DNA detected value exceeding 500 IU/ml or 2500 copies/mL); 6. Subjects with poorly controlled clinical cardiovascular symptoms or diseases, including but not limited to: (1) New York Heart Association (NYHA) Class II or higher heart failure; (2) Unstable angina pectoris; (3) History of myocardial infarction within 1 year; (4) Clinically significant supraventricular or ventricular arrhythmia without clinical intervention, or poorly controlled despite clinical intervention; 7. Severe infection (CTCAE Version 5.0 Grade > 2) occurring within 4 weeks prior to the first administration of the study drug, such as severe pneumonia, bacteremia, infectious complications requiring hospitalization, etc.; baseline chest imaging examination indicating the presence of active pulmonary inflammation; presence of symptoms and signs of infection or requiring oral or intravenous antibiotic use within
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Investigator-Assessed Pathological Complete Response Rate (pCR, including complete response in primary tumor and lymph nodes).; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-Free Survival;3-Year Event-Free Survival Rate (3-Year EFSR);Safety;Major Pathological Response Rate (MPR Rate);Objective Response Rate;Overall Survival; | — |
Countries
China
Contacts
Public ContactMinghuan Li
Shandong First Medical University and Shandong Academy of Medical Sciences (Shandong Cancer Hospital &Institute)
Outcome results
None listed