Gastric CancerNCT06432205
The Effect of MDT Plus SDM on Survival Benefit of Advanced Gastric Cancer
An observational study of Gastric Cancer, run by Peking University at 1 site in China.
Trial summary
The goal of this observational study is to learn about the long-term effect of surgery in metastatic gastric cancer patients who are accessed as having opportunity for surgery under Multi-disciplinary Team (MDT) evaluation. 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?
- surgery
- Type of treatment
- Surgery or procedure
- How many people
- 121 participants
- Where
- 1 siteChina
- Study dates
- 9 Nov 2023to Aug 2025
- 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
- No healthy volunteers
- Adult, Older adult
Study population: patient in Beijing Cancer Hospital
Who may be able to join
- Age ≥18 years old;
- Participate in the formal MDT discussion and evaluate feasible surgical treatment;
- Gastric adenocarcinoma or gastroesophageal junction adenocarcinoma confirmed by histology;
- Immunotherapy must be received during the treatment;
- At least 1 distant metastatic organs, and the number of metastases is ≥1;
- The subject line blood routine (within 7 days) and biochemical indicators (within 14 days) meet the following standards:
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- hemoglobin≥90g/L； absolute count of neutral granulocytes (ANC) ≥1.5×10^9/L； platelets≥100×10^9/L； Alt, AST≤ 2.5 times the normal upper limit，≤5 times the normal upper limit value (with liver metastasis)； ALP ≤ 2.5 times the normal upper limit，≤5 times the normal upper limit (with liver or bone metastasis)； total bilirubin<1.5 times the normal upper limit value of serum； serum creatinine<1.5 times normal upper limit； albumin≥30g/L；
- ECOG 0 ～ 1 point;
- The expected life span is ≥3 months;
- Cardiopulmonary function is basically normal;
- Women and spouses of childbearing age are willing to adopt effective contraceptive methods.
Who cannot join
- Those who do not meet the above selected standards or have chemotherapy contraindications;
- Combined with other primary malignant tumors;
- Pregnancy, lactating women or women of childbearing age and spouses refuse to adopt effective contraceptive methods;
- History of organ transplantation (including bone marrow autologous transplantation and peripheral stem cell transplantation);
- History of long -term treatment of steroids (Note: Short -term users discontinue drugs> 2 weeks can be selected);
- History of peripheral nervous system disorders or obvious mental disorders and central nervous system disorders;
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- Accompanied by severe infection;
- Accompanied by swallowing difficulties, complete or incomplete digestive tract obstruction, gastrointestinal bleeding, perforation, etc.;
- Severe liver disease (such as liver cirrhosis, etc.), kidney disease, respiratory disease, or chronic system diseases such as diabetes, hypertension, high blood pressure;
- Coronary heart disease with obvious clinical symptoms, such as: congestive heart failure, obvious symptoms, cardiac disorders, hypertension, or myocardial infarction seizures, or inadequate heart function within 6 months;
- Persons without legal capacity, medical or ethical reasons affecting the continuation of research.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142
Xiaotian Zhang, Professor
About this study
Official title: The Effect of Multi-Disciplinary Team Plus Shared-Decision Making on Survival Benefit of Advanced Gastric Cancer - a Single Center, Non-randomized, Prospective, Controlled Study
The goal of this observational study is to learn about the long-term effect of surgery in metastatic gastric cancer patients who are accessed as having opportunity for surgery under Multi-disciplinary Team (MDT) evaluation. The main question it aims to answer is:
Does surgery extend survival time in metastatic gastric cancer patients who are accessed as having opportunity for surgery under Multi-disciplinary Team (MDT) evaluation?
Read the detailed description
Select metastatic gastric cancer patients that have the opportunity to undergo any forms of surgery through MDT. Then further evaluate these patients' risks and benefits. Let patients make their finally decision through shared-decision making (SDM). According to the actual decision, the patients are divided into surgery group and non-surgery group.
- Conditions
- Gastric Cancer
- Being tested
- surgery
- Keywords
- multi-disciplinary Team, shared-decision making, surgery
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surgeryProcedure or surgery
any forms of surgery, such as all tumor resection, partial tumor resection and palliative tumor resection surgery
| Study group | Role | What they receive |
|---|---|---|
| surgery group | metastatic gastric cancer patients who are assessed as having the opportunity for surgery finally choose to undergo surgery after MDT plus SDM. Receives: Procedure: surgery | |
| non-surgery group | metastatic gastric cancer patients who are assessed as having the opportunity for surgery finally choose not to undergo surgery after MDT plus SDM. |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall survival
Measured: From diagnosis of metastatic gastric cancer to any cause of death，assessed up to 5 years
Secondary outcomes (2)
progression free survival
Measured: From diagnosis of metastatic gastric cancer to tumor progression or any cause of death, assessed up to 2 years
safety of surgery
any grade of adverse event
Measured: after surgery, assessed up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2024
- Study start9 Nov 2023
- Primary completionAug 2025 (estimated)
- Study completionAug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- More trials run by Peking UniversityThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 121 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06432205
- Sponsor's protocol ID
- 2023YJZ66
- Status last verified
- Feb 2024
- First submitted
- 15 May 2024
- Last updated
- 29 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Multi-Disciplinary Team Plus Shared-Decision Making on Survival Benefit of Advanced Gastric Cancer - a Single Center, Non-randomized, Prospective, Controlled Study
- ClinicalTrials.gov ID
- NCT06432205
- Acronym / sponsor ID
- 2023YJZ66
- Conditions
- Gastric Cancer
- Keywords
- multi-disciplinary Team, shared-decision making, surgery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 121 participants (estimated)
- Lead sponsor
- Peking UniversityUniversity, hospital or other
- Study start
- 9 Nov 2023 (actual)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 29 May 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 long-term effect of surgery in metastatic gastric cancer patients who are accessed as having opportunity for surgery under Multi-disciplinary Team (MDT) evaluation. The main question it aims to answer is:
Does surgery extend survival time in metastatic gastric cancer patients who are accessed as having opportunity for surgery under Multi-disciplinary Team (MDT) evaluation?
Detailed description
Select metastatic gastric cancer patients that have the opportunity to undergo any forms of surgery through MDT. Then further evaluate these patients' risks and benefits. Let patients make their finally decision through shared-decision making (SDM). According to the actual decision, the patients are divided into surgery group and non-surgery group.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| surgery group | – | Procedure: surgerymetastatic gastric cancer patients who are assessed as having the opportunity for surgery finally choose to undergo surgery after MDT plus SDM. |
| non-surgery group | – | –metastatic gastric cancer patients who are assessed as having the opportunity for surgery finally choose not to undergo surgery after MDT plus SDM. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patient in Beijing Cancer Hospital
Key inclusion criteria (11 listed)
- Age ≥18 years old;
- Participate in the formal MDT discussion and evaluate feasible surgical treatment;
- Gastric adenocarcinoma or gastroesophageal junction adenocarcinoma confirmed by histology;
- Immunotherapy must be received during the treatment;
- At least 1 distant metastatic organs, and the number of metastases is ≥1;
Key exclusion criteria (11 listed)
- Those who do not meet the above selected standards or have chemotherapy contraindications;
- Combined with other primary malignant tumors;
- Pregnancy, lactating women or women of childbearing age and spouses refuse to adopt effective contraceptive methods;
- History of organ transplantation (including bone marrow autologous transplantation and peripheral stem cell transplantation);
- History of long -term treatment of steroids (Note: Short -term users discontinue drugs> 2 weeks can be selected);
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 |
|---|---|---|
| surgeryany forms of surgery, such as all tumor resection, partial tumor resection and palliative tumor resection surgery | Procedure or surgery | surgery group |
Primary outcome
overall survival
Time frame: From diagnosis of metastatic gastric cancer to any cause of death，assessed up to 5 years
2 secondary outcomes
progression free survival
Time frame: From diagnosis of metastatic gastric cancer to tumor progression or any cause of death, assessed up to 2 years
safety of surgery
Time frame: after surgery, assessed up to 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2024.
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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.
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, run by Peking University 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 11 inclusion and 11 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 29 May 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiaotian Zhang, professor (010-88196561, zhangxiaotianmed@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall survival (time frame: From diagnosis of metastatic gastric cancer to any cause of death，assessed up to 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 May 2024.