Advanced Gastric Cancer
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1.Voluntarily sign the informed consent form; 2.Aged 18-75 years; 3.ECOG performance status 0-1; 4.Either sex; 5.Patients with a standardized histopathological diagnosis of gastric adenocarcinoma from the primary gastric lesion via endoscopic biopsy, according to the 15th edition of the Japanese Classification of Gastric Carcinoma (2017); 6.Patients judged by the treating physician to require preoperative immune checkpoint inhibitor therapy, followed by potentially curative gastrectomy; 7.Meet the diagnostic criteria for hypertension according to the 2023 Chinese Guidelines for the Management of Hypertension (systolic blood pressure >=140 mmHg and/or diastolic blood pressure >=90 mmHg, or a previous diagnosis of uncontrolled hypertension), with an indication for beta-blocker use; 8.Deemed by a specialist to have no contraindications for beta-blocker use and can use beta-blockers for antihypertensive therapy;
Exclusion criteria
Exclusion criteria: 1.HER2-positive or microsatellite instability-high (MSI-H)/dMMR gastric cancer confirmed by immunohistochemistry; 2.Active autoimmune disease requiring continuous immunosuppressive therapy or history of transplantation; 3.Currently receiving systemic immunosuppressive medication: If a patient is currently using corticosteroids, the corticosteroid dose must be <= equivalent of prednisone 10 mg daily; 4.History of (non-infectious) pneumonitis/interstitial lung disease requiring treatment; 5.Concurrent infection with human immunodeficiency virus (HIV); 6.Pregnant or breastfeeding women; 7.History of psychiatric disorders; 8.Concurrent other malignancies or severe organ dysfunction; 9.Presence of contraindications for beta-blocker use (e.g., severe bradycardia, uncontrolled depression, unstable angina, uncontrolled heart failure (Class III or IV), hypotension (systolic blood pressure <100 mmHg), severe asthma or chronic obstructive pulmonary disease (COPD), symptomatic peripheral arterial disease or Raynaud's syndrome, untreated pheochromocytoma, etc.); 10.Refractory hypertension; 11.Judged by the investigator as not meeting the inclusion criteria for this study;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients with tumor regression grade (TRG) < Grade 3 (per AJCC criteria); | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival was 3 years;Progression-free survival was 3 years;The relationship between immune-therapy-related biomarkers (such as PD-L1 expression, cortisol, ACTH, ADRB1 expression in tumor tissues, RNA sequencing in tumor tissues, tumor immune microenvironment, and immune cell status of lymph nodes before and after treatment);Treatment adherence (immunotherapy completion rate, surgery delay rate); | — |
Countries
China
Contacts
Southern Medical University Southern Hospital