Gastric CancerNCT06522542
Gastric Cancer Complicated With Bleeding
An observational study of Gastric Cancer, run by Peking University Third Hospital.
Trial summary
To investigate the impact of bleeding on the survival and treatment-related adverse events (TRAEs) of gastric cancer patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- systematic therapy
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2024to 31 Jul 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Advanced or metastatic gastric cancer at the Department of Medical Oncology and Radiation Sickness of Peking University Third Hospital.
Who may be able to join
- 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.
Who cannot join
- Incompletable clinical data;
- Siewert I type esophagus cancer.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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.
- Conditions
- Gastric Cancer
- Being tested
- systematic therapy
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
systematic therapyDrug
Also called chemotherapy, targeted therapy or immune checkpoint inhibitor
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.
| Study group | Role | What they receive |
|---|---|---|
| Test group | Gastirc cancer with bleeding at first diagnosis Receives: Drug: systematic therapy | |
| Control group | Gastirc cancer without bleeding at first diagnosis Receives: Drug: systematic therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival (OS)
OS was defined as the time from the first cycle of systematic therapy to death from any cause.
Measured: from date of the first cycle of systematic therapy to death from any cause，assessed up to 120 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2024
- Study start1 Aug 2024 (estimated)
- Primary completion31 Jul 2025 (estimated)
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yanhong Yao, Peking University Third Hospital
- Investigators
- Yanhong Yao, Principal investigator, Department of Medical Oncology and Radiation Sickness, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06522542
- Sponsor's protocol ID
- IRB00006761-M2023544
- Status last verified
- Jul 2024
- First submitted
- 19 Jul 2024
- Last updated
- 26 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The datasets analyzed during the study are available on reasonable request.
Publications
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.
PubMed 40747247
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Study on Anti-cancer Therapy for Gastric Cancer Patients Complicated With Bleeding
- ClinicalTrials.gov ID
- NCT06522542
- Acronym / sponsor ID
- IRB00006761-M2023544
- Conditions
- Gastric Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 1 Aug 2024 (estimated)
- Primary completion
- 31 Jul 2025 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 26 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To investigate the impact of bleeding on the survival and treatment-related adverse events (TRAEs) of gastric cancer patients.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test group | – | Drug: systematic therapyGastirc cancer with bleeding at first diagnosis |
| Control group | – | Drug: systematic therapyGastirc cancer without bleeding at first diagnosis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Advanced or metastatic gastric cancer at the Department of Medical Oncology and Radiation Sickness of Peking University Third Hospital.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- Incompletable clinical data;
- Siewert I type esophagus cancer.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| systematic therapyAlso: chemotherapy, targeted therapy or immune checkpoint inhibitorAll 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. | Drug | Control group, Test group |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2024.
- Derived from this study: PubMed 40747247Yao 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.
- Individual participant dataSharing planned: Yes. The datasets analyzed during the study are available on reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yanhong Yao principal investigator
Department of Medical Oncology and Radiation Sickness, Peking University Third Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Gastric Cancer, run by Peking University Third Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yanhong Yao (+86 010-82265857, snowdream246@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (OS) (time frame: from date of the first cycle of systematic therapy to death from any cause，assessed up to 120 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06522542, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2024; AzTrials last refreshed its copy on 1 Nov 2026.