GISTEMMBKMNCT05895942
Exploring the Molecular Mechanism Based on KIT Mutation
An observational study of GIST, run by Xijing Hospital at 1 site in China.
Trial summary
Imatinib remains suboptimal for recurrence/metastasis and unresectable GIST response rates. With the maturity of genomics and metabolomics, people gradually realize the role of gut microbiota in tumor therapy. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- GIST
- What is being tested?
- Imatinib
- How many people
- 190 participants
- Where
- 1 siteChina
- Study dates
- 10 Sep 2021to 10 Sep 2025
- How long will I take part?
- 2 Years
- 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
- Adult, Older adult
Study population: Chinese patients with unresectable C-kit9/11-mutated GIST
Who may be able to join
- BMI index 18.5-23.9kg/m2;
- Pathologically diagnosed patients with unresectable GIST, and genetic testing is C-kit9/11 mutation;
- No previous surgery;
- ECOG score: 0-1 points;
- Expected survival period ≥ 6 months;
- All patients should have measurable or evaluable target lesions;
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- Able to eat liquid diet The above; no complete gastrointestinal obstruction or perforation; no distant metastasis;
- The main organ functions are normal, that is, the following criteria are met:
- The blood routine examination standards must be met (no blood transfusion and blood products within 14 days, no G-CSF use) and other hematopoietic stimulating factors): a) HB≥80 g/L; b) ANC≥1.5×109/L; c) PLT≥100×109/L;
- Biochemical tests should meet the following criteria: a) TBIL <1.5×ULN; b) ALT and AST<2.0×ULN; c) Serum Cr≤1.5×ULN or endogenous creatinine clearance rate> 50 mL/min (Cockcroft-Gault formula);
- Pulmonary function assessment of normal lung function or mild to moderate abnormality (VC%>60%, FEV1>1.2L, FEV1%>40%, DLco>40%);
- Cardiovascular function evaluation: cardiac function grades I to II;
- Have certain self-care Ability and language comprehension.
Who cannot join
- 1. Patients with pathological types and primary tumor sites that do not meet the inclusion criteria;
- 2. There is a risk of gastrointestinal perforation;
- 3. Has undergone surgical treatment;
- 4. Have ever suffered from malignant tumor;
- 5. Those with a history of severe lung or heart disease;
- 6. Active infection or unexplained fever >38.5℃ within 2 weeks before randomization;
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- 7. Known major active infection, or the investigator judges that there is a major blood, renal, metabolic, gastrointestinal or endocrine dysfunction;
- 8. Those with a history of immunodeficiency, including HIV positive or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation;
- 9. The subject has active hepatitis B (HBV DNA ≥ 2000 IU/mL or 104 copies/mL), hepatitis C (positive hepatitis C antibody, and HCV-RNA is higher than the detection limit of the analytical method);
- 10. Those who have been vaccinated with live vaccines within 3 months before treatment;
- 11. During acute or chronic tuberculosis infection (positive T-spot test and suspected tuberculosis foci on chest X-ray);
- 12. Those with a history of drug, drug or alcohol abuse (drinking ≥5 times a week, etc.);
- 13. Intravenous infusion cannot be performed;
- 14. Severe diarrhea in the past 2 months (watery stools ≥ 3 times per day and lasted ≥ 3 days);
- 15. Severe constipation (≤2 times of defecation per week with difficulty in defecation) in the past 2 months;
- 16. Antibiotics have been used in the past 2 months for 3 days or more;
- 17. Have used proton pump gastric drugs, acid suppressants, mucosal protective agents, opioid psychotropic drugs, hormones, immunosuppressants, cytotoxic drugs and other drugs within the past 2 months for 3 days or more;
- 18. Have used probiotics, prebiotics or synbiotic within the past 2 months for 3 days or more;
- 19. Received drug treatment for the following diseases in the past 1 month: cholecystitis, peptic ulcer, urinary tract infection, acute pyelonephritis, cystitis, hyperthyroidism and other abnormal thyroid function;
- 20. Gastrointestinal surgery, appendicitis surgery, enema, colon cleansing and other medical operations within the past 1 year;
- 21. During pregnancy and lactation (women) or lactose intolerance;
- 22. Patients with high blood pressure that cannot be reduced to the normal range after antihypertensive drug treatment (systolic blood pressure>140 mmHg, diastolic blood pressure>90 mmHg); patients with a history of unstable angina pectoris; newly diagnosed within 3 months before screening Angina pectoris or myocardial infarction within 6 months before screening; arrhythmia (including QTcF: ≥450 ms for men, ≥470 ms for women) requires long-term use of antiarrhythmic drugs and New York Heart Association classification ≥ grade II cardiac insufficiency;
- 23. According to the judgment of the investigator, the subject has other factors that may cause him to be forced to terminate the study halfway, such as suffering from other serious diseases (including mental illness) requiring combined treatment, serious abnormal laboratory test values, family or social factors, Situations that may affect the safety of subjects or the collection of trial data;
- 24. The investigator judges other circumstances that may affect the conduct of clinical research and the judgment of research results;
- 25. Research center staff, researcher's partner or first-degree relative;
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xijing Hospital of Air Force Military Medical University
Xi'an, Shaanxi, 710000
shu Wang, 15249257112, ws0286@163.com
About this study
Official title: Exploring the Molecular Mechanism of Secondary Resistance to Imatinib in Gastrointestinal Stromal Tumors Based on KIT Mutation
Imatinib remains suboptimal for recurrence/metastasis and unresectable GIST response rates. With the maturity of genomics and metabolomics, people gradually realize the role of gut microbiota in tumor therapy. The gut microbiota may affect tumor treatment by regulating the tumor microenvironment or the host immune system, and some bacteria can fight tumors by activating the immune system. Growing evidence shows that the effect of tumor therapy is related to the composition of the gut microbiota of patients, and that the composition of the gut microbiota of patients sensitive to drug treatment has certain characteristics, and these characteristics may be used as biomarkers to predict the prognosis of treatment. At present, it remains unclear whether the efficacy of imatinib is related to the gut microbiota in GIST patients. Therefore, precise mining of microbial information and the development of reasonable and feasible microbial interventions are expected to optimize the treatment strategy of GIST to a large extent and provide a basis for individualized treatment of advanced GIST.
Read the detailed description
Taking Chinese patients with unresectable C-kit9/11-mutated GIST as the research object, the treatment effect was observed after standardized treatment with imatinib mesylate. To explore the relationship between intestinal flora and the efficacy of imatinib treatment, to find new biomarkers to predict the efficacy of imatinib, and to provide reference for individualized treatment of imatinib
- Conditions
- GIST
- Being tested
- Imatinib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ImatinibDrug
Also called treat
The control group, before and after imatinib treatment, and patients with different efficacy of imatinib treatment were collected, and the correlation analysis was performed to screen the key flora and metabolites that affect the efficacy of imatinib
| Study group | Role | What they receive |
|---|---|---|
| Imatinib treatment group | Chinese patients with unresectable C-kit9/11-mutated GIST were selected as the research subjects, and the therapeutic effect was observed after standard treatment with imatinib mesylate Receives: Drug: Imatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of tumor regression
We used the RECIST 1.1 evaluation criteria to evaluate the response to the imatinib therapy and accordingly divided patients into two groups,Response and No Response.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2023
- Study start10 Sep 2021
- Primary completion10 Sep 2024 (estimated)
- Study completion10 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GISTStudies 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
- 190 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- jun j Yang, Master, Study chair, The First Affiliated Hospital of Air Force Medicial University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05895942
- Sponsor's protocol ID
- TQXB-GIST-001
- Acronym
- EMMBKM
- Status last verified
- Jul 2022
- First submitted
- 19 Jul 2022
- Last updated
- 9 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Molecular Mechanism of Secondary Resistance to Imatinib in Gastrointestinal Stromal Tumors Based on KIT Mutation
- ClinicalTrials.gov ID
- NCT05895942
- Acronym / sponsor ID
- EMMBKM / TQXB-GIST-001
- Conditions
- GIST
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 190 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- 10 Sep 2021 (actual)
- Primary completion
- 10 Sep 2024 (estimated)
- Study completion
- 10 Sep 2025 (estimated)
- First posted
- 9 Jun 2023 (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.
Imatinib remains suboptimal for recurrence/metastasis and unresectable GIST response rates. With the maturity of genomics and metabolomics, people gradually realize the role of gut microbiota in tumor therapy. The gut microbiota may affect tumor treatment by regulating the tumor microenvironment or the host immune system, and some bacteria can fight tumors by activating the immune system. Growing evidence shows that the effect of tumor therapy is related to the composition of the gut microbiota of patients, and that the composition of the gut microbiota of patients sensitive to drug treatment has certain characteristics, and these characteristics may be used as biomarkers to predict the prognosis of treatment. At present, it remains unclear whether the efficacy of imatinib is related to the gut microbiota in GIST patients. Therefore, precise mining of microbial information and the development of reasonable and feasible microbial interventions are expected to optimize the treatment strategy of GIST to a large extent and provide a basis for individualized treatment of advanced GIST.
Detailed description
Taking Chinese patients with unresectable C-kit9/11-mutated GIST as the research object, the treatment effect was observed after standardized treatment with imatinib mesylate. To explore the relationship between intestinal flora and the efficacy of imatinib treatment, to find new biomarkers to predict the efficacy of imatinib, and to provide reference for individualized treatment of imatinib
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Imatinib treatment group | – | Drug: ImatinibChinese patients with unresectable C-kit9/11-mutated GIST were selected as the research subjects, and the therapeutic effect was observed after standard treatment with imatinib mesylate |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Chinese patients with unresectable C-kit9/11-mutated GIST
Key inclusion criteria (13 listed)
- BMI index 18.5-23.9kg/m2;
- Pathologically diagnosed patients with unresectable GIST, and genetic testing is C-kit9/11 mutation;
- No previous surgery;
- ECOG score: 0-1 points;
- Expected survival period ≥ 6 months;
Key exclusion criteria (25 listed)
- 1. Patients with pathological types and primary tumor sites that do not meet the inclusion criteria;
- 2. There is a risk of gastrointestinal perforation;
- 3. Has undergone surgical treatment;
- 4. Have ever suffered from malignant tumor;
- 5. Those with a history of severe lung or heart disease;
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 |
|---|---|---|
| ImatinibAlso: treatThe control group, before and after imatinib treatment, and patients with different efficacy of imatinib treatment were collected, and the correlation analysis was performed to screen the key flora and metabolites that affect the efficacy of imatinib | Drug | Imatinib treatment group |
Primary outcome
Degree of tumor regression
Time frame: 6 months
We used the RECIST 1.1 evaluation criteria to evaluate the response to the imatinib therapy and accordingly divided patients into two groups,Response and No Response.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2023.
- Individual participant dataSharing planned: No
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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.
jun j Yang, Master study chair
The First Affiliated Hospital of Air Force Medicial University
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 GIST, run by Xijing Hospital 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 13 inclusion and 25 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 9 Jun 2023. 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 jun j Yang, Master (135 7253 3693, yangjj@fmmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Degree of tumor regression (time frame: 6 months). 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 9 Jun 2023; AzTrials last refreshed its copy on 28 Oct 2026.