Gastric Cancer Complicated With Bleeding

July 24, 2024 updated by: Yanhong Yao, Peking University Third Hospital

Retrospective Study on Anti-cancer Therapy for Gastric Cancer Patients Complicated With Bleeding

To investigate the impact of bleeding on the survival and treatment-related adverse events (TRAEs) of gastric cancer patients.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

We will retrospectively enroll patients diagnosed with advanced or metastatic gastric cancer at the Department of Medical Oncology and Radiation Sickness of Peking University Third Hospital. The retrospective study aims to investigate the impact of bleeding on treatment-related adverse events (TRAEs) for gastric cancer patients receiving systematic anticancer treatment, assess the influence of bleeding on the survival of patients.

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

Advanced or metastatic gastric cancer at the Department of Medical Oncology and Radiation Sickness of Peking University Third Hospital.

Description

Inclusion Criteria:

  1. Patients older than 18 years;
  2. A histologically confirmed diagnosis of advanced or metastatic gastric cancer;
  3. The initial anticancer treatment was systematic therapy, including chemotherapy, targeted therapy or immune checkpoint inhibitor (ICI);
  4. No history of gastrectomy before systematic therapy.

Exclusion Criteria:

  1. Incompletable clinical data;
  2. Siewert I type esophagus cancer.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Test group
Gastirc cancer with bleeding at first diagnosis
Drug: systematic therapy
All patients received systematic therapy including chemotherapy, targeted therapy or immune checkpoint inhibitor. We aims to investigate the impact of bleeding on the survival and treatment-related adverse events (TRAEs) of gastric cancer patients.
Other Names:
  • chemotherapy, targeted therapy or immune checkpoint inhibitor
Control group
Gastirc cancer without bleeding at first diagnosis
Drug: systematic therapy
All patients received systematic therapy including chemotherapy, targeted therapy or immune checkpoint inhibitor. We aims to investigate the impact of bleeding on the survival and treatment-related adverse events (TRAEs) of gastric cancer patients.
Other Names:
  • chemotherapy, targeted therapy or immune checkpoint inhibitor

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival (OS)
Time Frame: from date of the first cycle of systematic therapy to death from any cause，assessed up to 120 months
OS was defined as the time from the first cycle of systematic therapy to death from any cause.
from date of the first cycle of systematic therapy to death from any cause，assessed up to 120 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University Third Hospital

Investigators

  • Principal Investigator: Yanhong Yao, Department of Medical Oncology and Radiation Sickness, Peking University Third Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 1, 2024

Primary Completion (Estimated)

July 31, 2025

Study Completion (Estimated)

July 31, 2026

Study Registration Dates

First Submitted

July 19, 2024

First Submitted That Met QC Criteria

July 24, 2024

First Posted (Actual)

July 26, 2024

Study Record Updates

Last Update Posted (Actual)

July 26, 2024

Last Update Submitted That Met QC Criteria

July 24, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00006761-M2023544

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The datasets analyzed during the study are available on reasonable request.

IPD Sharing Time Frame

After the trial is completed

IPD Sharing Access Criteria

Used for scientific research

IPD Sharing Supporting Information Type

  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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