Clinical trial · Observational
Beta-Blockers on Neoadjuvant Immunochemotherapy for Hypertensive Patients With Gastric Cancer
Beta-blockers Combined With Neoadjuvant Immunochemotherapy Significantly Improve Pathological Remission in Locally Advanced Gastric Cancer: a Multicenter Controlled Study Based on Hypertensive Patients
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Study Population: Patients with locally advanced gastric cancer complicated by primary hypertension, who received neoadjuvant immunochemotherapy followed by curative gastrectomy at Nanfang Hospital of Southern Medical University and other participating centers between April 2021 and December 2025. Primary Objective: To investigate the impact of beta-blocker use versus non-beta-blocker antihypertensive agents on the efficacy of neoadjuvant immunochemotherapy in patients with locally advanced gastric cancer and hypertension. Secondary Objective: To investigate the impact of beta-blocker use versus non-beta-blocker antihypertensive agents on the incidence of immune-related adverse events (irAEs). Study Groups: Patients are divided into two groups based on antihypertensive medication use during immunotherapy: the exposed group (patients continuously using beta-blockers during neoadjuvant immunochemotherapy) and the control group (patients continuously receiving non-beta-blocker antihypertensive agents, including ACEI/ARB, CCB, or diuretics, during the same period). Study Design: This is a multicenter, retrospective, observational cohort study. Study Duration: May 2026 - December 2026 Sample Size: A total of 80 eligible patients are planned for inclusion, with 40 patients in the beta-blocker exposed group and 40 patients in the non-beta-blocker control group. Inclusion Criteria: * Voluntarily provided informed consent for data use; * Age between 18 and 85 years; * No restriction on gender; * Histopathologically confirmed gastric adenocarcinoma from the primary lesion via endoscopic biopsy, according to the 15th edition of the Japanese Classification of Gastric Carcinoma (2017); * Received neoadjuvant immunochemotherapy followed by curative gastrectomy between April 2021 and December 2025. Exclusion Criteria: * Pregnant or breastfeeding women; * Severe psychiatric disorders; * Previous history of chemotherapy, radiotherapy, or targeted therapy; * History of other malignant tumors within the past 5 years; * dMMR or MSI-H status determined by immunohistochemistry or PCR-based assays * Active infection, active/refractory autoimmune disease, or uncontrolled systemic disease; * Patients judged by the investigator to be unsuitable for participation in this study.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastric Cancer (GC) | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (2)
- label
- Beta-blocker exposed group
- description
- Patients with locally advanced gastric cancer complicated by primary hypertension, who continuously received beta-blockers (e.g., metoprolol, bisoprolol) for antihypertensive treatment during neoadjuvant immunochemotherapy, followed by curative gastrectomy.
- label
- Non-beta-blocker control group
- description
- Patients with locally advanced gastric cancer complicated by primary hypertension, who continuously received non-beta-blocker antihypertensive agents (e.g., ACEI/ARB, CCB, diuretics) for blood pressure control during neoadjuvant immunochemotherapy, with no exposure to beta-blockers, followed by curative gastrectomy.
Primary outcomes (1)
- measure
- Pathological response of MPR
- timeFrame
- 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.
- description
- Major pathological response (MPR) is defined as the proportion of patients with ≤10% residual viable tumor cells in the surgically resected primary tumor following neoadjuvant therapy. MPR is assessed on the surgical specimen obtained approximately 1 week after completion of preoperative treatment. Pathological evaluation is performed according to standardized tumor regression grading (TRG) systems, with MPR corresponding to TRG 0-1 per AJCC 8th edition criteria (i.e., complete response or minimal residual disease). This endpoint will be reported descriptively with point estimate and 95% confidence interval.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: * Aged between 18 and 85 years; * No restriction on gender; * 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 who received neoadjuvant immunochemotherapy followed by curative gastrectomy at Nanfang Hospital of Southern Medical University and other participating centers between April 2021 and December 2025. Exclusion Criteria: * Pregnant or breastfeeding women; * Severe psychiatric disorders; * Previous history of chemotherapy, radiotherapy, or targeted therapy prior to study treatment; * History of other malignant tumors within the past 5 years; * dMMR or MSI-H status determined by immunohistochemistry or PCR-based assays * Active infection, active or refractory autoimmune disease, or uncontrolled systemic disease; * Patients judged by the investigator to be unsuitable for participation in this study.
References
Publications (0)
Data not yet available