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

NCT07622693 | Active Not Recruiting

• 1 other identifier: NFEC-2026-285
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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)

Keywords

Gastric Cancer; Immunotherapy; Beta-Blockers; Pathological regression

Outcome Measures

Primary Outcomes (1)

• Pathological response of MPR

  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.

  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.

Secondary Outcomes (6)

• Pathological Complete Response (pCR) Rate

  Assessed on postoperative pathological specimens, approximately 1 week after surgical resection (within 4 months after completion of neoadjuvant immunochemotherapy).

• Pathological Non-Response (TRG 3) Rate

  Assessed on postoperative pathological specimens, approximately 1 week after surgical resection (within 4 months after completion of neoadjuvant immunochemotherapy)

• Objective Response Rate (ORR)

  Assessed on pre-surgical imaging, within 1 week before surgery (approximately 3 months after initiation of neoadjuvant immunochemotherapy)

• 3-Year Progression-Free Survival (PFS)

  Assessed at 3 years after surgical resection, with annual follow-up

• 3-Year Overall Survival (OS)

  Assessed at 3 years after surgical resection, with annual follow-up

Other Outcomes (1)

• Correlation Between Beta-Blocker Dose and Immunotherapy Efficacy

  Assessed on postoperative pathological specimens, approximately 1 week after surgical resection (within 4 months after completion of neoadjuvant immunochemotherapy)

Study Arms (2)

Beta-blocker exposed group

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.

Non-beta-blocker control group

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.

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study population consists of patients with locally advanced gastric adenocarcinoma complicated by primary hypertension, who received neoadjuvant immunochemotherapy followed by curative laparoscopic gastrectomy.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nanfang Hospital, Southern Medical University: lead
• The First Affiliated Hospital of Xiamen University: collaborator
• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School: collaborator
• The First Medical Center of Chinese PLA General Hospital: collaborator
• Peking University Shenzhen Hospital: collaborator
• First Affiliated Hospital Xi'an Jiaotong University: collaborator

Study Sites (1)

Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, 510515, China

Location

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2026
• First Posted: June 3, 2026
• Study Start: May 10, 2026
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: June 3, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)