Exploring the Molecular Mechanism Based on KIT Mutation

NCT05895942 | Unknown

• 1 other identifier: TQXB-GIST-001
• Study Type: observational
• Target: 190
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

GIST

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months

Study Arms (1)

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

Drug: Imatinib

Interventions

Imatinib DRUG

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

Also known as: treat

Imatinib treatment group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Chinese patients with unresectable C-kit9/11-mutated GIST

You may qualify if:

• 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;
• 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.

You may not qualify if:

• \. There is a risk of gastrointestinal perforation;
• \. Has undergone surgical treatment;
• \. Have ever suffered from malignant tumor;
• \. Those with a history of severe lung or heart disease;
• \. Active infection or unexplained fever \>38.5℃ within 2 weeks before randomization;
• \. Known major active infection, or the investigator judges that there is a major blood, renal, metabolic, gastrointestinal or endocrine dysfunction;
• \. Those with a history of immunodeficiency, including HIV positive or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation;
• \. 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);
• \. Those who have been vaccinated with live vaccines within 3 months before treatment;
• \. During acute or chronic tuberculosis infection (positive T-spot test and suspected tuberculosis foci on chest X-ray);
• \. Those with a history of drug, drug or alcohol abuse (drinking ≥5 times a week, etc.);
• \. Intravenous infusion cannot be performed;
• \. Severe diarrhea in the past 2 months (watery stools ≥ 3 times per day and lasted ≥ 3 days);
• \. Severe constipation (≤2 times of defecation per week with difficulty in defecation) in the past 2 months;
• \. Antibiotics have been used in the past 2 months for 3 days or more;

Sponsors & Collaborators

• Xijing Hospital: lead

Study Sites (1)

Xijing Hospital of Air Force Military Medical University

Xi'an, Shaanxi, 710000, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

stool specimen Serum Specimen

MeSH Terms

Interventions

Imatinib Mesylate; Coal Tar

Intervention Hierarchy (Ancestors)

Benzamides; Amides; Organic Chemicals; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines; Tars; Complex Mixtures

Study Officials

• jun j Yang, Master

  The First Affiliated Hospital of Air Force Medicial University

  STUDY CHAIR

Central Study Contacts

jun j Yang, Master

CONTACT

135 7253 3693; yangjj@fmmu.edu.cn

shu Wang

CONTACT

15249257112; ws0286@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2022
• First Posted: June 9, 2023
• Study Start: September 10, 2021
• Primary Completion: September 10, 2024
• Study Completion: September 10, 2025
• Last Updated: June 9, 2023

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)