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Beta-Blockers on Neoadjuvant Immunochemotherapy for Hypertensive Patients With Gastric Cancer

NCT07622693 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 80

Last updated 2026-06-03

No results posted yet for this study

Summary

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

  • Gastric Cancer (GC)

Sponsors & Collaborators

  • The First Affiliated Hospital of Xiamen University

    collaborator OTHER

  • The First Medical Center of Chinese PLA General Hospital

    collaborator OTHER

  • Peking University Shenzhen Hospital

    collaborator OTHER

  • First Affiliated Hospital Xi'an Jiaotong University

    collaborator OTHER

  • The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

    collaborator OTHER

  • Nanfang Hospital, Southern Medical University

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-10
Primary Completion
2026-10-31
Completion
2026-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07622693 on ClinicalTrials.gov