Gastric CancerNCT06493448
Prospective Observational Cohort Study
An observational study of Gastric Cancer and Liver Metastases, run by Lin Chen at 1 site in China.
Trial summary
The goal of this observational study is to learn about the overall disease status, diagnostic and therapeutic modalities, and prognosis of patients with gastric cancer liver metastasis(GCLM) in China. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Cancer, Liver Metastases
- What is being tested?
- observation
- How many people
- 1,326 participants
- Where
- 1 siteChina
- Study dates
- 15 Jul 2024to 31 Dec 2028
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Study population: The main study population was: patients diagnosed with liver metastases from gastric cancer who met the inclusion and exclusion criteria in China. Patient care in various tertiary hospitals throughout the country.
Who may be able to join
- aged ≥18 years
- gastric primary lesions confirmed by pathology and liver metastases confirmed by pathology or imaging (before, during, or after initial treatment)
- expected survival time of ≥ 12 weeks
- Eastern Cooperative Oncology Group Physical Status Score (ECOG PS score) of 0-2
- signed informed consent
- good compliance and ability to complete regular follow-up
Who cannot join
- heterochronous liver metastases
- multi-centra clinics with significant missing case information
- diagnosed, suspected or active autoimmune disease
- history of immunodeficiency
- history of allogeneic organ and haematopoietic stem cell transplantation
- pregnant or breastfeeding female patients
Show all 20Show fewer
- uncontrolled co-morbidities, including but not limited to:
- a.HIV-infected (HIV-positive) patients
- b.severe infections that are active or poorly controlled clinically
- c.evidence of severe or uncontrolled systemic disease
- - severe psychiatric disease
- - severe neurological disease
- - epilepsy
- - dementia
- - unstable or uncompensated respiratory
- - cardiovascular
- - hepatic disease
- - renal disease
- - uncontrolled hypertension
- Abnormal coagulation in people with active bleeding or new thrombotic disease, on therapeutic doses of anticoagulants, or with bleeding tendencies.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Chinese PLA General Hospital
Beijing, Beijing Municipality, 100853
Hong qing Xi, PhD, 800-555-5555, xihongqing301@163.com
Lin Chen, PhD, luting2023@126.com
About this study
Official title: Prospective Observational Study of Gastric Cancer Synchronous Liver Metastases: a Multi-centre, Noninterventional, Cohort Study
The goal of this observational study is to learn about the overall disease status, diagnostic and therapeutic modalities, and prognosis of patients with gastric cancer liver metastasis(GCLM) in China. The investigators divided the participants into three groups( three types) of gastric cancer liver metastasis based onChinese c-GCLM classification system.The main question it aims to answer is:
- How long do patients with GCLM live?
- How different treatment modalities (surgery, chemotherapy, immunotherapy, targeted therapy and others) affect patients' prognosis of three type? All participants will be tracked for their physical condition.
Read the detailed description
This is a prospective, non-interventional, observational, multi-centre, real-world study designed to monitor the general condition, treatment pattern and prognosis of patients with GCLM. GCLM patients were divided into 3 types: Type I (resectable type), Type II (potentially resectable type), Type III (unresectable type). The patients' general information, past medical history, imaging results, laboratory tests, surgical and systemic therapy details will be recorded and analysed. The 2-year overall survival (OS) will be recorded as the primary endpoint. The different therapies (surgery, chemotherapy and immunotherapy) of GCLM, the effects of different therapies on prognosis including OS of type I, II and III; R0 resection rate and diease free survival (DFS) of type I; successful conversion rate and R0 resection rate and events free survival (EFS) of type II will be recorded as secondary endpoints.
This study involving human participants were reviewed and approved by the Ethics Committee of Chinese PLA General Hospital (No.S2023-724-02) and will be conducted according to the guidelines of the Declaration of Helsinki. Study findings will be disseminated through international peer-reviewed journal articles as well as public, academic presentations at national and international conferences.
- Conditions
- Gastric Cancer, Liver Metastases
- Being tested
- observation
- Keywords
- gastric cancer, liver metastasis, observation, treatment, prognosis
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
observationOther
This is an observational study.
| Study group | Role | What they receive |
|---|---|---|
| Cohort A | Type I liver metastases, resectable type, with the option of direct surgical resection or preoperative systemic therapy Receives: Other: observation | |
| Cohort B | Type II liver metastases, potentially resectable type, preoperative systemic therapy is applied to gain the chance of surgery Receives: Other: observation | |
| Cohort C | Type III liver metastases, systemic treatment according to recommended guidelines and patient characteristics Receives: Other: observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
2-year OS
The primary study endpoint was two-year survival in patients
Measured: 2 years OS from diagnosed time to measured time or death
Secondary outcomes (6)
OS of type I（questionnaires, phone calls, and outpatient follow-up.）
the effects of different therapeutic modalities (surgery, chemotherapy, immunotherapy, targeted therapy and others) on prognosis.
Measured: OS from diagnosed time to measured time or death（up to 5 years）
OS of type II （questionnaires, phone calls, and outpatient follow-up.）
the effects of different therapeutic modalities (surgery, chemotherapy, immunotherapy, targeted therapy and others) on prognosis.
Measured: OS from diagnosed time to measured time or death（2 to 5 years）
OS of type III（questionnaires, phone calls, and outpatient follow-up.）
the effects of different therapeutic modalities (surgery, chemotherapy, immunotherapy, targeted therapy and others) on prognosis.
Measured: OS from diagnosed time to measured time or death（no more than 2 years）
DFS of type I（questionnaires, phone calls, and outpatient follow-up.）
DFS of type I. Disease-free survival time maintained after the participant has been saved by therapeutic measures.Especially in patients underwent radical surgery.
Measured: Through study completion, an average of 2 year.
R0 resection rate (pathological information from medical record.)
Proportion of all operated patients achieving radical resection.
Measured: Through study completion, an average of 2 year.
successful conversion therapy rate (pathological information and surgery information from medical record.)
Proportion of type II patients underwent radical surgery after systemic treatment.
Measured: Through study completion, an average of 2 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2024
- Study start15 Jul 2024 (estimated)
- Primary completion30 Jul 2026 (estimated)
- Study completion31 Dec 2028 (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
- Prospective
- Enrolment
- 1,326 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Lin Chen
- Sponsor type
- University, hospital or other
- Collaborators
- Peking University International Hospital, Chinese PLA General Hospital
- Responsible party
- Sponsor-investigator, Lin Chen, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06493448
- Sponsor's protocol ID
- XHongqing
- Status last verified
- Jul 2024
- First submitted
- 22 Apr 2024
- Last updated
- 10 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Lu T, Gao Y, Zhang G, Zhang H, Chen Z, Liu Y, Chen L, Xi H. Gastric cancer liver metastases in China: a real-world, multicentre, prospective, observational cohort study protocol. BMJ Open. 2025 Jan 8;15(1):e086276. doi: 10.1136/bmjopen-2024-086276.
PubMed 39779263
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Observational Study of Gastric Cancer Synchronous Liver Metastases: a Multi-centre, Noninterventional, Cohort Study
- ClinicalTrials.gov ID
- NCT06493448
- Acronym / sponsor ID
- XHongqing
- Conditions
- Gastric Cancer, Liver Metastases
- Keywords
- gastric cancer, liver metastasis, observation, treatment, prognosis
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,326 participants (estimated)
- Lead sponsor
- Lin ChenUniversity, hospital or other
- Collaborators
- Peking University International Hospital, Chinese PLA General Hospital
- Study start
- 15 Jul 2024 (estimated)
- Primary completion
- 30 Jul 2026 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 10 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.
The goal of this observational study is to learn about the overall disease status, diagnostic and therapeutic modalities, and prognosis of patients with gastric cancer liver metastasis(GCLM) in China. The investigators divided the participants into three groups( three types) of gastric cancer liver metastasis based onChinese c-GCLM classification system.The main question it aims to answer is:
- How long do patients with GCLM live?
- How different treatment modalities (surgery, chemotherapy, immunotherapy, targeted therapy and others) affect patients' prognosis of three type? All participants will be tracked for their physical condition.
Detailed description
This is a prospective, non-interventional, observational, multi-centre, real-world study designed to monitor the general condition, treatment pattern and prognosis of patients with GCLM. GCLM patients were divided into 3 types: Type I (resectable type), Type II (potentially resectable type), Type III (unresectable type). The patients' general information, past medical history, imaging results, laboratory tests, surgical and systemic therapy details will be recorded and analysed. The 2-year overall survival (OS) will be recorded as the primary endpoint. The different therapies (surgery, chemotherapy and immunotherapy) of GCLM, the effects of different therapies on prognosis including OS of type I, II and III; R0 resection rate and diease free survival (DFS) of type I; successful conversion rate and R0 resection rate and events free survival (EFS) of type II will be recorded as secondary endpoints.
This study involving human participants were reviewed and approved by the Ethics Committee of Chinese PLA General Hospital (No.S2023-724-02) and will be conducted according to the guidelines of the Declaration of Helsinki. Study findings will be disseminated through international peer-reviewed journal articles as well as public, academic presentations at national and international conferences.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort A | – | Other: observationType I liver metastases, resectable type, with the option of direct surgical resection or preoperative systemic therapy |
| Cohort B | – | Other: observationType II liver metastases, potentially resectable type, preoperative systemic therapy is applied to gain the chance of surgery |
| Cohort C | – | Other: observationType III liver metastases, systemic treatment according to recommended guidelines and patient characteristics |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The main study population was: patients diagnosed with liver metastases from gastric cancer who met the inclusion and exclusion criteria in China. Patient care in various tertiary hospitals throughout the country.
Key inclusion criteria (6 listed)
- aged ≥18 years
- gastric primary lesions confirmed by pathology and liver metastases confirmed by pathology or imaging (before, during, or after initial treatment)
- expected survival time of ≥ 12 weeks
- Eastern Cooperative Oncology Group Physical Status Score (ECOG PS score) of 0-2
- signed informed consent
Key exclusion criteria (20 listed)
- heterochronous liver metastases
- multi-centra clinics with significant missing case information
- diagnosed, suspected or active autoimmune disease
- history of immunodeficiency
- history of allogeneic organ and haematopoietic stem cell transplantation
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 |
|---|---|---|
| observationThis is an observational study. | Other | Cohort A, Cohort B, Cohort C |
Primary outcome
2-year OS
Time frame: 2 years OS from diagnosed time to measured time or death
The primary study endpoint was two-year survival in patients
6 secondary outcomes
OS of type I（questionnaires, phone calls, and outpatient follow-up.）
Time frame: OS from diagnosed time to measured time or death（up to 5 years）
OS of type II （questionnaires, phone calls, and outpatient follow-up.）
Time frame: OS from diagnosed time to measured time or death（2 to 5 years）
OS of type III（questionnaires, phone calls, and outpatient follow-up.）
Time frame: OS from diagnosed time to measured time or death（no more than 2 years）
DFS of type I（questionnaires, phone calls, and outpatient follow-up.）
Time frame: Through study completion, an average of 2 year.
R0 resection rate (pathological information from medical record.)
Time frame: Through study completion, an average of 2 year.
successful conversion therapy rate (pathological information and surgery information from medical record.)
Time frame: Through study completion, an average of 2 year.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2024.
- Derived from this study: PubMed 39779263Lu T, Gao Y, Zhang G, Zhang H, Chen Z, Liu Y, Chen L, Xi H. Gastric cancer liver metastases in China: a real-world, multicentre, prospective, observational cohort study protocol. BMJ Open. 2025 Jan 8;15(1):e086276. doi: 10.1136/bmjopen-2024-086276.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastric Cancer and Liver Metastases, run by Lin Chen at 1 site in China.
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 6 inclusion and 20 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: opening soon, as of the sponsor's last update on 10 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hong qing Xi, PhD (17330925741, xihongqing301@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
2-year OS (time frame: 2 years OS from diagnosed time to measured time or death). 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 NCT06493448, 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 10 Jul 2024.