Adenocarcinoma of the Stomach and Esophagogastric Junction
Conditions
Interventions
Trial Group:Relafusp alfa 1800 mg, intravenous infusion, Q3W. When combined with chemotherapy, Relafusp alfa injection should be administered first, followed by chemotherapy after an interval of at le
Sponsors
Xijing Hospital, Air Force Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Patients must meet all of the following inclusion criteria to be enrolled in this study: 1. Subjects voluntarily join this study, sign the informed consent form, have good compliance, and cooperate with follow-up; 2. Age 18-75 years; both male and female; 3. Histopathological examination of gastric biopsy confirms locally advanced gastric or gastroesophageal junction adenocarcinoma; 4. Imaging (CT/MRI) and endoscopic ultrasound confirm: clinical stage T1-4aN M0, T3-4N0M0; 5. ECOG score: 0-1; 6. Expected survival >=12 weeks; 7. HER2 negative; 8. Major organ functions within 7 days before treatment meet the following criteria: (1) Complete blood count (within 14 days without transfusion): Hemoglobin (HB) >=90 g/L; Absolute neutrophil count (ANC) >=1.5×10^9/L; Platelet count (PLT) >=80×10^9/L; (2) Biochemical tests must meet the following criteria: Total bilirubin (TBIL) =60 ml/min; (3) Doppler ultrasound assessment: left ventricular ejection fraction (LVEF) >= lower limit of normal (50%). 9. Women of childbearing potential must agree to use contraception during the study and for 6 months after the study (such as intrauterine device, contraceptive pills, or condoms); must test negative for serum or urine pregnancy within 7 days before enrollment, and must not be breastfeeding; men must agree to use contraception during the study and for 6 months after the study; 10. Patients voluntarily participate in this study and sign the informed consent form.
Exclusion criteria
Exclusion criteria: Patients with any of the following conditions are not eligible for enrollment in this study: Patients with a history or presence of other malignancies within 5 years, except cured carcinoma in situ of the cervix, non-melanoma skin cancer, and superficial bladder cancer (Ta, Tis, and T1). Patients at high risk of bleeding or fistula due to obvious tumor invasion into adjacent organs (aorta or trachea). Subjects with diseases requiring systemic therapy with glucocorticoids (>10 mg prednisone equivalent daily) or other immunosuppressive drugs within 14 days before study treatment. Inhaled or topical steroids and adrenal replacement therapy >10 mg prednisone equivalent daily are permitted in the absence of active autoimmune diseases. Patients with severe malnutrition. Patients receiving intravenous nutrition or requiring hospitalization for continuous infusion are excluded. Patients with well-controlled nutrition >= 28 days may be enrolled. Participants who received live/attenuated vaccines within 30 days before the first treatment. Unresolved toxicities > CTCAE 4.0 Grade 2 caused by any prior therapy, excluding alopecia and oxaliplatin-induced neurotoxicity = 150 mmHg, diastolic blood pressure >= 100 mmHg); Myocardial ischemia/infarction = Grade I, arrhythmia (QTc >= 480 ms), or congestive heart failure >= Grade 2 (NYHA classification); Severe or uncontrolled active infection >= CTCAE Grade 2; Renal failure requiring hemodialysis or peritoneal dialysis; Immunodeficiency including HIV positivity, or history of organ transplantation; Uncontrolled diabetes mellitus (FBG >10 mmol/L); active or suspected autoimmune diseases (exceptions allowed: Type 1 diabetes, hypothyroidism managed by hormone replacement only, skin diseases not requiring systemic therapy); Seizures requiring treatment; History of interstitial lung disease, pulmonary fibrosis, pneumonitis, or severely impaired lung function. Patients with intestinal obstruction (including incomplete obstruction) or other gastrointestinal diseases at risk of hemorrhage, perforation, or obstruction. Patients who underwent major surgery, incisional biopsy, or significant traumatic injury within 28 days before enrollment. Patients with any bleeding event >= CTCAE Grade 2 within 4 weeks before enrollment, or with unhealed wounds, ulcers, or fractures. Arterial/venous thrombosis events (cerebrovascular accident, transient ischemic attack, deep vein thrombosis, pulmonary embolism) within 3 months. Planning to undergo or having received allogeneic organ or bone marrow transplantation (including liver transplantation). Any concomitant disease that, in the investigator’s judgment, may seriously compromise patient safety or interfere with study completion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological Complete Response Rate (pCR); | — |
Secondary
| Measure | Time frame |
|---|---|
| R0 Resection Rate;Event-Free Survival (EFS);Major Pathological Response Rate (MPR);Overall Survival (OS);Safety Outcomes (including adverse events and perioperative complications); | — |
Countries
China
Contacts
Public ContactJianjun Yang
Xijing Hospital, Air Force Medical University
Outcome results
None listed