NCT06376773

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
234

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2022

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2023

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 15, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 19, 2024

Completed
Last Updated

April 19, 2024

Status Verified

April 1, 2024

Enrollment Period

1.1 years

First QC Date

April 15, 2024

Last Update Submit

April 17, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • overall survival

    overall survival

    2years

Secondary Outcomes (1)

  • objective response rate

    6months

Study Arms (4)

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

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

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

Interventions

Apatinib, chemotherapy alone, Camrelizumab

Also known as: mesenchymal, immunogenic, metabolic, classic
immunogenicmesenchymal

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • diagnosed with gastric adenocarcinoma and received neoadjuvant therapy

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fujian Medical University Union Hospital

Fuzhou, Fuji'an, 350000, China

Location

MeSH Terms

Interventions

Drug Therapy, CombinationapatinibcamrelizumabMetabolic Networks and PathwaysCongresses as Topic

Intervention Hierarchy (Ancestors)

Drug TherapyTherapeuticsMetabolismOrganizationsHealth Care Economics and Organizations

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Fujian Medical University

Study Record Dates

First Submitted

April 15, 2024

First Posted

April 19, 2024

Study Start

June 1, 2022

Primary Completion

July 1, 2023

Study Completion

November 30, 2023

Last Updated

April 19, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations