Neoadjuvant Treatment Based on Gastric Cancer Molecular Subtyping.

Neoadjuvant Treatment Based on Gastric Cancer Molecular Subtyping: Chemotherapy, Immunotherapy, or Targeted Therapy? -A Retrospective Real-World Data Analysis

Extensive research employing diverse omics methodologies has unveiled a varied landscape of gastric cancer (GC). Recent progress in next-generation sequencing and other genomic technologies has facilitated a more intricate exploration of GC at the molecular level. This study aimed to identify the most effective drug therapeutics for patients with the mesenchymal subtype of gastric cancer.Based on RNA-seq transcriptome, 234 patients were divided into four molecular subtypes: mesenchymal, immunogenic, metabolic, and classic.Our analysis has revealed that, for neoadjuvant therapy in advanced gastric cancer (AGC), the mesenchymal subtype stands out as the ideal patient population benefiting from Apatinib, without a concurrent increase in postoperative complications.

Study Overview

• Status: Completed
• Conditions: Neoadjuvant Therapy; Advanced Gastric Cancer; Multi-omics Analysis
• Intervention / Treatment: Procedure: combination chemotherapy with Apatinib or Camrelizumab

Detailed Description

The advent of immunotherapy and targeted therapies has recently provided new options for AGC treatment. However, not all patients benefit from immunotherapy or targeted therapy, resulting in unsatisfactory overall treatment outcomes during the perioperative period. An ineffective treatment imposes significant financial burden, causes drug-related side effects that deteriorate their quality of life, and potentially delays subsequent treatment.

Evaluate the objective response rate (ORR) of the combination of camrelizumb, apatinib, and neoadjuvant chemotherapy for the treatment of advanced gastric patient Median survival time (OS);

Disease free survival time (DFS);

• Study Type: Observational
• Enrollment (Actual): 234

Contacts and Locations

Study Locations

• China
  • Fujian
    • Fuzhou, Fujian, China, 350000
      • Fujian Medical University Union Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

This study collected data from 234 patients diagnosed with gastric adenocarcinoma at Fujian Medical University Union Hospital (FMUUH) who underwent gastrectomy after receiving neoadjuvant therapy (NAT) between January 2019 and January 2022.

Description

Inclusion Criteria:

• diagnosed with gastric adenocarcinoma and received neoadjuvant therapy

Exclusion Criteria:

• Patients with distant metastases, gastric stump cancer, or missing neoadjuvant chemotherapy data were excluded from the study.

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
mesenchymal; Based on RNA-seq transcriptome, patients were divided into mesenchymal, and received neoadjuvant chemotherapy with apatinib or not	Procedure: combination chemotherapy with Apatinib or Camrelizumab; Apatinib, chemotherapy alone, Camrelizumab; Other Names: mesenchymal; immunogenic; metabolic; classic
immunogenic; Based on RNA-seq transcriptome, patients were divided into immunogenic, and received neoadjuvant chemotherapy with Camrelizumab or not	Procedure: combination chemotherapy with Apatinib or Camrelizumab; Apatinib, chemotherapy alone, Camrelizumab; Other Names: mesenchymal; immunogenic; metabolic; classic
metabolic; Based on RNA-seq transcriptome, patients were divided into metabolic, and received neoadjuvant chemotherapy with apatinib, Camrelizumab or not
classic; Based on RNA-seq transcriptome, patients were divided into classic, and received neoadjuvant chemotherapy with apatinib, Camrelizumab or not

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
overall survival	overall survival	2years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
objective response rate	objective response rate	6months

Collaborators and Investigators

• Sponsor: Fujian Medical University

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2022
• Primary Completion (Actual): July 1, 2023
• Study Completion (Actual): November 30, 2023

Study Registration Dates

• First Submitted: April 15, 2024
• First Submitted That Met QC Criteria: April 17, 2024
• First Posted (Actual): April 19, 2024

Study Record Updates

• Last Update Posted (Actual): April 19, 2024
• Last Update Submitted That Met QC Criteria: April 17, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Stomach Neoplasms; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Protein Kinase Inhibitors; Apatinib
• Other Study ID Numbers: 2022KY123

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No