gastric
Conditions
Interventions
Treatment group:
Adebrelimab 1200 mg per dose on day 1 (D1), administered via intravenous infusion every three weeks (Q3W)
when combined with chemotherapy, adebrelimab should be administered first, followed by chemotherapy after an interval of at least 30 minutes.
Tegafur-gimeracil-oteracil (S-1) 40-60 mg twice daily (bid
Oxaliplatin 130 mg/m2 on day 1 (d1)
Apatinib 250 mg orally (po), once daily (qd).
Sponsors
Xijing Hospital, Air Force Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Subjects voluntarily join this study, sign the informed consent form, have good compliance, and cooperate with follow-up. 2.Age 18-75 years; no gender restriction. 3.Histopathological examination of biopsy tissue via gastroscopy confirms locally advanced gastric or gastroesophageal junction adenocarcinoma. 4.Imaging (CT/MRI) and endoscopic ultrasound confirm: clinical stage T3-4aN+M0. 5.ECOG performance status: 0-1. 6.Expected survival =12 weeks. 7.Major organ function within 7 days before treatment meets the following criteria: Hematologic examination standards (no blood transfusion within 14 days): Hemoglobin (HB) =90 g/L; Absolute neutrophil count (ANC) =1.5×10^9/L; Platelets (PLT) =80×10^9/L. Biochemical examination must meet the following standards: Total bilirubin (TBIL) =1.5 times the upper limit of normal (ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =2.5×ULN; Serum creatinine (Cr) =1.5×ULN or creatinine clearance (CCr) =60 ml/min. Doppler ultrasound assessment: left ventricular ejection fraction (LVEF) = the lower limit of normal (50%). 8.Women of childbearing potential must agree to use contraception (such as intrauterine device, contraceptives, or condoms) during the study and for 6 months after the end of the study; serum or urine pregnancy test within 7 days before enrollment must be negative, and they must be non-lactating; men must agree to use contraception during the study and for 6 months after the end of the study. 9.Patients voluntarily participate in this study and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Subjects who have had or currently have another malignancy within the past 5 years, except for cured in situ cervical cancer, non-melanoma skin cancer, and superficial bladder tumors [Ta (non-invasive tumors), Tis (carcinoma in situ), and T1 (tumor invades lamina propria)]. 2. Patients with a high risk of bleeding or fistula due to significant tumor invasion into adjacent organs (major arteries or trachea). 3. Subjects with diseases requiring systemic treatment with corticosteroids (daily dose >10 mg prednisone or equivalent) or other immunosuppressive drugs within 14 days before the start of study treatment. In the absence of active autoimmune disease, inhaled or topical steroids greater than 10 mg daily prednisone equivalent and adrenal replacement steroid doses are allowed. 4. Subjects with significant malnutrition. Patients receiving intravenous nutritional support or requiring continuous infusion therapy and hospitalization are excluded. Patients with well-controlled nutrition for =28 days before randomization can be enrolled. 5. Participants who have received live or attenuated vaccines within 30 days after the first treatment. 6. Subjects with unresolved toxicity reactions higher than grade 2 according to CTCAE 4.02 from any previous therapy, except for alopecia and =2 grade peripheral neuropathy caused by oxaliplatin. 7. Allergic reactions and adverse drug reactions: 1) History of allergy to the components of the study drug; 2) Contraindications to any study drugs in the chemotherapy regimen (DOS). 8. Patients with any severe and/or uncontrolled diseases, including: 1) Patients with uncontrolled hypertension despite antihypertensive medication (systolic blood pressure =150 mmHg, diastolic blood pressure =100 mmHg); 2) Patients with myocardial ischemia or myocardial infarction above grade I, arrhythmias (including QTc =480 ms), or =2 grade congestive heart failure (New York Heart Association [NYHA] classification); 3) Severe or uncontrolled diseases or active infections (=CTCAE grade 2) deemed by the investigator to increase the risk associated with study participation or study drug administration, or that may interfere with the subject’s ability to receive study medication; 4) Renal failure requiring hemodialysis or peritoneal dialysis; 5) History of immunodeficiency diseases, including HIV positivity or other acquired or congenital immunodeficiency diseases, or a 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 1 diabetes, hypothyroidism due to autoimmune thyroiditis only requiring hormone replacement therapy, skin conditions not requiring systemic treatment (e.g., vitiligo, psoriasis, or alopecia) can be enrolled; 7) Patients with epilepsy requiring treatment; 8) Subjects with interstitial lung disease, history of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonitis, severe pulmonary impairment, or other conditions that may interfere with the detection and management of suspected drug-related pulmonary toxicity. 9. Patients with current bowel obstruction (including incomplete bowel obstruction) or gastrointestinal diseases that may cause gastrointestinal bleeding, perforation, or obstruction as determined by the investigator. 10. Patients who have undergone surgical treatment, incisional biopsy,
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pCR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Major pathological response rate, MPR: TRG1a/b;Disease free survival, DFS;R0 resection rate;Overall survival, OS;Objective response rate, ORR;Safety; | — |
Countries
China
Contacts
Public ContactFan Feng
Xijing Hospital, Air Force Medical University
Outcome results
None listed