Gastric CancerNCT04501887
The Efficacy of Precision Treatment for Gastric Cancer Guided by Molecular Profiling
An observational study of Gastric Cancer, run by Shanghai Zhongshan Hospital.
Trial summary
Gastric cancer (GC) is one of the most common and lethal cancers worldwide, especially in China, and the median overall survival for patients with advanced, metastatic GC remains only about 1 year. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Gastric Cancer
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2021to 1 Jul 2023
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with biopsy-confirmed gastric cancer at stage IV who conducted molecular testing are included.
Who may be able to join
- Male or female. Age: 18-80 years.
- Histologically confirmed adenocarcinoma of the stomach or gastro-esophageal junction with inoperable locally advanced or recurrent and/or metastatic disease, not amenable to curative therapy.
- Measurable disease, according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, assessed using imaging techniques (CT or MRI).
- Multidimensional molecular biology profiling has been conducted using tumor or blood sample.
- ECOG Performance status 0-1.
- Life expectancy of at least 3 months.
- Signed informed consent.
Who cannot join
- The quality of NGS reports does not fit the requirement.
- History of documented congestive heart failure; angina pectoris requiring medication; evidence of transmural myocardial infarction on ECG; poorly controlled hypertension (systolic BP > 180 mmHg or diastolic BP > 100 mmHg); clinically significant valvular heart disease; or high risk uncontrollable arrhythmias.
- Baseline LVEF < 50% (measured by echocardiography or MUGA).
- Patients with dyspnea at rest due to complications of advanced malignancy or other disease, or who require supportive oxygen therapy.
- Patients receiving chronic or high dose corticosteroid therapy. (Inhaled steroids and short courses of oral steroids for anti-emesis or as an appetite stimulant are allowed).
- Known dihydropyrimidine dehydrogenase (DPD) deficiency.
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- History or clinical evidence of brain metastases.
- Serious uncontrolled systemic intercurrent illness, e.g. infections or poorly controlled diabetes.
- Positive serum pregnancy test in women of childbearing potential.
- Subjects with reproductive potential not willing to use an effective method of contraception.
- Major surgery within 4 weeks of start of study treatment, without complete recovery.
- Patients with known active infection with HIV, HBV, or HCV.
About this study
Official title: The Efficacy of Precision Treatment for Gastric Cancer Guided by Multidimensional Molecular Biology Profiling: a Multi-center Clinical Study
Gastric cancer (GC) is one of the most common and lethal cancers worldwide, especially in China, and the median overall survival for patients with advanced, metastatic GC remains only about 1 year. Several molecular profiling studies have demonstrated that a proportion of gastric cancer harbour actionable molecular alterations which shows a predictive benefit from a specific therapy (in any cancer type). In the current study, the efficacy of precision treatment for gastric cancer guided by multidimensional molecular biology profiling will be observed. The analysis focused on the overall survival outcomes for patients whose tumours harboured actionable molecular alterations and who received appropriately matched therapy.
- Conditions
- Gastric Cancer
- Keywords
- gastric cancer, precision medicine
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Matched therapy | Molecular profiling performed with actionable molecular alterations detected and target therapy was then conducted | |
| Unmatched therapy | Molecular profiling performed with actionable molecular alterations detected but therapy was conducted based on the guideline treatment | |
| No marker | Molecular profiling performed without any actionable molecular alterations detected, tranditional therapy based on the guideline was then conducted |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Overall survival was measured from the date of advanced disease until death.
Measured: up to 3 years
Progression-free survival
The PFS was calculated from the date of advanced disease to the date of disease progression or death
Measured: up to 3 years
Secondary outcomes (1)
Positive rate
Actionable molecular alterations detected by molecular profiling
Measured: up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2020
- Study start1 Jan 2021 (estimated)
- Primary completion1 Jul 2022 (estimated)
- Study completion1 Jul 2023 (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 Shanghai Zhongshan HospitalThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tianshu Liu, Shanghai Zhongshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04501887
- Sponsor's protocol ID
- ZS-ON-100
- Status last verified
- Aug 2020
- First submitted
- 4 Aug 2020
- Last updated
- 6 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Precision Treatment for Gastric Cancer Guided by Multidimensional Molecular Biology Profiling: a Multi-center Clinical Study
- ClinicalTrials.gov ID
- NCT04501887
- Acronym / sponsor ID
- ZS-ON-100
- Conditions
- Gastric Cancer
- Keywords
- gastric cancer, precision medicine
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 1 Jan 2021 (estimated)
- Primary completion
- 1 Jul 2022 (estimated)
- Study completion
- 1 Jul 2023 (estimated)
- First posted
- 6 Aug 2020 (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.
Gastric cancer (GC) is one of the most common and lethal cancers worldwide, especially in China, and the median overall survival for patients with advanced, metastatic GC remains only about 1 year. Several molecular profiling studies have demonstrated that a proportion of gastric cancer harbour actionable molecular alterations which shows a predictive benefit from a specific therapy (in any cancer type). In the current study, the efficacy of precision treatment for gastric cancer guided by multidimensional molecular biology profiling will be observed. The analysis focused on the overall survival outcomes for patients whose tumours harboured actionable molecular alterations and who received appropriately matched therapy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Matched therapy | – | –Molecular profiling performed with actionable molecular alterations detected and target therapy was then conducted |
| Unmatched therapy | – | –Molecular profiling performed with actionable molecular alterations detected but therapy was conducted based on the guideline treatment |
| No marker | – | –Molecular profiling performed without any actionable molecular alterations detected, tranditional therapy based on the guideline was then conducted |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with biopsy-confirmed gastric cancer at stage IV who conducted molecular testing are included.
Key inclusion criteria (7 listed)
- Male or female. Age: 18-80 years.
- Histologically confirmed adenocarcinoma of the stomach or gastro-esophageal junction with inoperable locally advanced or recurrent and/or metastatic disease, not amenable to curative therapy.
- Measurable disease, according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, assessed using imaging techniques (CT or MRI).
- Multidimensional molecular biology profiling has been conducted using tumor or blood sample.
- ECOG Performance status 0-1.
Key exclusion criteria (12 listed)
- The quality of NGS reports does not fit the requirement.
- History of documented congestive heart failure; angina pectoris requiring medication; evidence of transmural myocardial infarction on ECG; poorly controlled hypertension (systolic BP > 180 mmHg or diastolic BP > 100 mmHg); clinically significant valvular heart disease; or high risk uncontrollable arrhythmias.
- Baseline LVEF < 50% (measured by echocardiography or MUGA).
- Patients with dyspnea at rest due to complications of advanced malignancy or other disease, or who require supportive oxygen therapy.
- Patients receiving chronic or high dose corticosteroid therapy. (Inhaled steroids and short courses of oral steroids for anti-emesis or as an appetite stimulant are allowed).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Overall survival
Time frame: up to 3 years
Overall survival was measured from the date of advanced disease until death.
Progression-free survival
Time frame: up to 3 years
The PFS was calculated from the date of advanced disease to the date of disease progression or death
1 secondary outcome
Positive rate
Time frame: up to 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastric Cancer, run by Shanghai Zhongshan 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 7 inclusion and 12 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 6 Aug 2020. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: up to 3 years). The study lists 2 primary outcomes in all. 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 6 Aug 2020.