Beta-Blockers on the Efficacy of Neoadjuvant Immunotherapy for Gastric Cancer

Sponsor
Nanfang Hospital, Southern Medical University
Study ID
NCT07511894
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Experimental Group — DRUG
    Subjects in the experimental group will start taking metoprolol succinate extended-release tablets 47.5 mg (one tablet) once daily, starting from Day 1 of the first cycle of preoperative neoadjuvant immunotherapy, and continue until the day before surgery.

Study Details

Study Population:Patients with locally advanced gastric cancer complicated by hypertension, who are scheduled to undergo laparoscopic gastric cancer resection after receiving preoperative immunotherapy. Primary Objective: To investigate the impact of combined beta-blocker use on the efficacy of immunotherapy in patients with locally advanced gastric cancer. Secondary Objective: To investigate the impact of combined beta-blocker use on the incidence of immune-related adverse events. Study Groups:This study does not include a parallel control group; it enrolls only a single study group. Study Design:This is a single-arm, exploratory clinical study. Study Duration:2026 - 2029 Sample Size: Single-arm, exploratory trial, planned enrollment of 33 cases. Inclusion Criteria: * Voluntarily sign the informed consent form; * Aged 18-75 years; * ECOG performance status 0-1; * Either sex; * 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); * Patients judged by the treating physician to require preoperative immune checkpoint inhibitor therapy, followed by potentially curative gastrectomy; * 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; * Deemed by a specialist to have no contraindications for beta-blocker use and can use beta-blockers for antihypertensive therapy. Exclusion Criteria * HER2-positive or microsatellite instability-high (MSI-H)/dMMR gastric cancer confirmed by immunohistochemistry; * Active autoimmune disease requiring continuous immunosuppressive therapy or history of transplantation; * Currently receiving systemic immunosuppressive medication: If a patient is currently using corticosteroids, the corticosteroid dose must be ≤ equivalent of prednisone 10 mg daily; * History of (non-infectious) pneumonitis/interstitial lung disease requiring treatment; * Concurrent infection with human immunodeficiency virus (HIV); * Pregnant or breastfeeding women; * History of psychiatric disorders; * Concurrent other malignancies or severe organ dysfunction; * 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.); * Refractory hypertension; * Judged by the investigator as not meeting the inclusion criteria for this study. Effectiveness Analysis Primary Endpoint: Proportion of patients with Tumor Regression Grade (TRG) \< 3 (AJCC criteria). Secondary Endpoints: 3-year overall survival (OS), 3-year progression-free survival (PFS); correlation with immunotherapy-related biomarkers (e.g., PD-L1 expression, cortisol, adrenocorticotropic hormone, tumor tissue ADRB1 expression, tumor tissue RNA sequencing, tumor immune microenvironment); treatment compliance (immunotherapy completion rate, surgery delay rate). Safety Analysis:Incidence and severity of adverse events. Statistical Analysis:This is an exploratory, single-arm, uncontrolled study. The pathological response rate is the primary evaluation indicator, with a planned enrollment of 33 cases. The sample size was calculated based on the single-sample rate estimation method. Referring to similar exploratory immunotherapy combination studies and considering clinical practice, the anticipated pathological response rate is 80%. Using a two-sided α=0.05 (95% confidence level) and the Clopper-Pearson exact method, the two-sided 95% confidence interval for 33 samples is \[0.625, 0.918\], with an interval width of 0.294, which meets the core objective of preliminarily verifying the efficacy trend of the "standard immunotherapy + beta-blocker" regimen. A 10% dropout rate is also accounted for, balancing recruitment feasibility with basic statistical estimation precision. Descriptive statistical analysis will be used to calculate point estimates and 95% confidence intervals for primary and secondary endpoints. Survival analysis will use the Kaplan-Meier method to plot 3-year OS and PFS curves. Follow-up:Follow-up will be conducted at 1, 3, 6, 9, 12, 15, 18, 21, 24, 30, and 36 months post-surgery.

Key Dates

First listed
Apr 6, 2026
Start date
May 20, 2026
Status verified
May 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2030

Study Design

Enrollment
33 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Experimental group
    Subjects in the experimental group will start taking metoprolol succinate extended-release tablets 47.5 mg (one tablet) once daily, starting from Day 1 of the first cycle of preoperative neoadjuvant immunotherapy, and continue until the day before surgery.

Primary Outcome Measure

Pathological response of TRG3 [ Time Frame: From completion of neoadjuvant therapy to surgical resection; assessed on postoperative pathological specimen approximately 1 week after surgery, up to 4 months after study treatment initiation. ]

Central Contacts

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