Gastric Cancer Complicated With Bleeding

NCT06522542 | Not Yet Recruiting

• 1 other identifier: IRB00006761-M2023544
• Study Type: observational
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Gastric Cancer

Outcome Measures

Primary Outcomes (1)

• Overall survival (OS)

  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

Study Arms (2)

Test group

Gastirc cancer with bleeding at first diagnosis

Drug: systematic therapy

Control group

Gastirc cancer without bleeding at first diagnosis

Drug: systematic therapy

Interventions

systematic therapy DRUG

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.

Also known as: chemotherapy, targeted therapy or immune checkpoint inhibitor

Control group; Test group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• Incompletable clinical data;
• Siewert I type esophagus cancer.

Sponsors & Collaborators

• Peking University Third Hospital: lead

Related Publications (1)

• Yao Y, Liu Z, Zhang H, Shi X, Huang F, Zhang Y, Chen L, Shi Y, Cao B. Feasibility of systemic therapy in unresectable gastric/gastroesophageal junction cancer with overt bleeding. Asia Pac J Oncol Nurs. 2025 Jul 7;12:100750. doi: 10.1016/j.apjon.2025.100750. eCollection 2025 Dec.

  PMID: 40747247 DERIVED

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Drug Therapy; Immune Checkpoint Inhibitors

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Therapeutics; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Antineoplastic Agents, Immunological; Antineoplastic Agents; Therapeutic Uses

Study Officials

• Yanhong Yao

  Department of Medical Oncology and Radiation Sickness, Peking University Third Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yanhong Yao

CONTACT

+86 010-82265857; snowdream246@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Medical Oncology and Radiation Sickness

Study Record Dates

• First Submitted: July 19, 2024
• First Posted: July 26, 2024
• Study Start: August 1, 2024
• Primary Completion: July 31, 2025
• Study Completion (Estimated): July 31, 2026
• Last Updated: July 26, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: After the trial is completed
• Access Criteria: Used for scientific research