Advanced gastric cancer
Conditions
Interventions
Group 1:Total gastrectomy
Group 2:Proximal gastrectomy
Sponsors
China-Japan Friendship Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Sign a written informed consent form before any trial-related procedures are performed. 2.Male or female, aged >= 18 years. 3.Histologically confirmed adenocarcinoma of the upper stomach or esophagogastric junction, diagnosed as locally advanced disease according to the AJCC 8th edition, with cTNM stage cT3-4a or N+ M0 based on endoscopic ultrasound or contrast-enhanced CT/MRI (with the use of endoscopic ultrasound and diagnostic laparoscopy if necessary), and the lesion is considered resectable by the investigator. 4.Previously received neoadjuvant chemotherapy and immunotherapy for gastric cancer. 5.Agree to undergo radical surgery and be judged by the surgeon as having no surgical contraindications; 6.ECOG performance status 0–1. 7.Expected survival > 6 months. 8.Adequate organ function, meeting the following laboratory criteria: (1) Absolute neutrophil count (ANC) >=1.5 × 10?/L without the use of granulocyte colony-stimulating factor in the previous 14 days; (2) Platelet count >= 100 × 10?/L without blood transfusion in the previous 14 days; (3) Hemoglobin > 90 g/L without blood transfusion or erythropoietin use in the previous 14 days; (4) Total bilirubin = 60 mL/min; (7) Adequate coagulation function, defined as international normalized ratio (INR) or prothrombin time (PT) <= 1.5 × ULN; (8) Normal thyroid function, defined as thyroid-stimulating hormone (TSH) within the normal range. Subjects with baseline TSH outside the normal range may still be enrolled if total T3 (or free T3) and free T4 are within normal limits; (9) Cardiac enzymes within the normal range (isolated laboratory abnormalities considered not clinically significant by the investigator are allowed). 9.For women of childbearing potential, a negative urine or serum pregnancy test must be obtained within 3 days before the first dose of study drug (Day 1 of Cycle 1). If the urine pregnancy test cannot be confirmed as negative, a serum pregnancy test is required. Non-childbearing potential is defined as postmenopausal for at least 1 year, or having undergone surgical sterilization or hysterectomy. 10.All subjects (both male and female) who are at risk of pregnancy must use a contraceptive method with a failure rate < 1% throughout the treatment period and for at least 120 days after the last dose of study drug (or 180 days after the last dose of chemotherapy). 11.The patient is assessed by preoperative imaging to have clinical stage T1-3N0 and is considered eligible for proximal gastrectomy.
Exclusion criteria
Exclusion criteria: 1.Diagnosed with another malignancy other than gastric cancer within 5 years before the first dose (excluding curatively treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and/or carcinoma in situ that has been completely resected). 2.Known endoscopic evidence of active bleeding from the lesion. 3.Currently participating in another interventional clinical study, or having received another investigational drug or device within 4 weeks before the first dose. 4.Pregnant or breastfeeding women. 5.Presence of any severe or uncontrolled systemic disease, such as: (1) Significant and symptomatic abnormalities in resting ECG rhythm, conduction or morphology, e.g., complete left bundle branch block, second-degree or higher atrioventricular block, ventricular arrhythmias or atrial fibrillation; (2) Unstable angina, congestive heart failure, or chronic heart failure of New York Heart Association (NYHA) class >= 2; (3) Any arterial thrombosis, embolism or ischemia (e.g., myocardial infarction, unstable angina, cerebrovascular accident or transient ischemic attack) within 6 months before enrollment; (4) Active pulmonary tuberculosis; (5) Active or uncontrolled infection requiring systemic therapy; (6) Clinically active diverticulitis, abdominal abscess, or gastrointestinal obstruction; (7) Liver disease such as cirrhosis, decompensated liver disease, or acute/chronic active hepatitis; (8) Mental disorders that prevent the patient from cooperating with the treatment; (9) Any history or evidence of disease, treatment, or laboratory abnormality that might interfere with the trial results or prevent the subject from full participation, or any other condition that the investigator considers inappropriate for enrollment (e.g., potential risks that would make participation unsuitable).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1-year postoperative nutritional status and reflux status; | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety of proximal gastrectomy versus total gastrectomy; | — |
Countries
China
Contacts
Public ContactLei Zhou
China-Japan Friendship Hospital
Outcome results
None listed