Adenocarcinoma of the Esophagogastric Junction
Conditions
Interventions
Trial Group:Retlirafusp alfa injection: 20 mg/kg, intravenous drip (i.v.gtt.), Q2W. When combined with chemotherapy, Ruilafupu Alpha injection should be administered first, followed by chemotherapy af
Sponsors
Xijing Hospital, Air Force Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Patients must meet all of the following criteria to be enrolled in this study: (1) The subject voluntarily participates in this study, signs the informed consent form, has good compliance, and is able to cooperate with follow-up; (2) Age 18–75 years, male or female; (3) Histologically confirmed resectable adenocarcinoma of the esophagogastric junction, Siewert type I–III; (4) Confirmed by imaging (CT/MRI) and endoscopic ultrasound as: clinical stage T1-4aN+M0, or T3-4N0M0; (5) ECOG performance status score of 0–1; (6) Expected survival >=12 weeks; (7) PD-L1 expression CPS > 1, HER2 negative; (8) Major organ function meeting the following criteria within 7 days prior to treatment: 1) Hematology (without blood transfusion within 14 days): • Hemoglobin (HB) >=90 g/L; • Absolute neutrophil count (ANC) >=1.5×10^9/L; • Platelet count (PLT) >=80×10^9/L. 2) Biochemistry: • Total bilirubin (TBIL) =60 mL/min. 3) Doppler echocardiography assessment: left ventricular ejection fraction (LVEF) >= lower limit of normal (50%). (9) Female patients of childbearing potential must agree to use contraceptive measures (e.g., intrauterine device, contraceptive pills, or condoms) during the study and for 6 months after study completion; must have a negative serum or urine pregnancy test within 7 days prior to enrollment, and must not be lactating. Male patients must agree to use contraceptive measures during the study and for 6 months after study completion; (10) The patient voluntarily participates in this study and signs the informed consent form.
Exclusion criteria
Exclusion criteria: 1.Patients with any of the following criteria will not be enrolled in this study: (1) Presence of or prior history of other malignancies within the past 5 years, except for cured cervical carcinoma in situ, non-melanoma skin cancer, and superficial bladder tumors [Ta (non-invasive tumor), Tis (carcinoma in situ), and T1 (tumor invading the basement membrane)]; (2) Patients with a high risk of bleeding or fistula formation due to significant tumor invasion into adjacent organs (e.g., major arteries or trachea); (3) Subjects requiring systemic treatment with glucocorticoids (daily dose >10 mg prednisone equivalent) or other immunosuppressive agents within 14 days prior to the start of study treatment. In the absence of active autoimmune disease, inhaled or topical steroids and adrenal replacement steroid doses >10 mg prednisone equivalent per day are permitted; (4) Patients with significant malnutrition. Patients receiving intravenous nutritional support or requiring hospitalization for continuous infusion therapy will be excluded. Patients who have achieved good nutritional control for >=28 days prior to treatment may be enrolled; (5) Participants who have received live/attenuated vaccines within 30 days after the first treatment; (6) Unresolved toxicity > Grade 4.02 (CTCAE) from any prior treatment, excluding alopecia and =150 mmHg, diastolic blood pressure >=100 mmHg); 2). Grade I or higher myocardial ischemia or myocardial infarction, arrhythmias (including QTc >=480 ms), and >= Grade 2 congestive heart failure (New York Heart Association [NYHA] classification); 3). Severe or uncontrolled diseases or active infections (>= CTCAE Grade 2) that, in the investigator's judgment, would increase the risk associated with study participation or study drug administration, or affect the subject's ability to receive the study drug; 4).Renal failure requiring hemodialysis or peritoneal dialysis; 5). History of immunodeficiency, including HIV positivity or other acquired/congenital immune deficiency diseases, or history of organ transplantation; 6). Poorly controlled diabetes mellitus (fasting blood glucose [FBG] >10 mmol/L); subjects with active, known, or suspected autoimmune diseases. Subjects with type I diabetes mellitus, residual hypothyroidism due to autoimmune thyroiditis requiring only hormone replacement therapy, or skin disorders not requiring systemic treatment (e.g., vitiligo, psoriasis, or alopecia) may be enrolled; 7). Patients with epilepsy requiring treatment; 8). Previous or current history of interstitial lung disease, pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonitis, or severely impaired lung function that may interfere with the detection and management of suspected drug-related pulmonary toxicity. (9) Current gastrointestinal disorders such as intestinal obstruction (including incomplete obstruction) or conditions that, in the investigator's judgment, may cause gastrointestinal bleeding, perforation, or obstruction; (10) Patients who have underg
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 ContactXiaohua Li
Xijing Hospital, Air Force Medical University
Outcome results
None listed