Using Imatinib Mesylate before surgery for gastrointestinal stromal tumors
Prospective Multicenter Clinical Study of Neoadjuvant Imatinib Mesylate for Gastrointestinal Stromal Tumors
This study is testing if taking imatinib mesylate before surgery can help people with high-risk gastrointestinal stromal tumors have better outcomes and live longer.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 122 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | First Affiliated Hospital of Zhejiang University Academic / other |
| Drugs / interventions | Imatinib |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Trial ID | NCT04933669 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of neoadjuvant therapy with imatinib mesylate in patients with high-risk gastrointestinal stromal tumors (GIST). The primary goal is to assess the 5-year progression-free survival rate following treatment. Participants must have a histologically confirmed GIST that tests positive for specific genetic markers and meet certain size criteria. The study aims to improve surgical outcomes and long-term survival rates for these patients.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 80 with high-risk gastrointestinal stromal tumors that are c-Kit positive.
Not a fit: Patients with specific mutations in the PDGFRA gene or those who have previously been treated with tyrosine kinase inhibitors may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve surgical outcomes and long-term survival for patients with high-risk GIST.
How similar studies have performed: Previous studies have shown promising results with neoadjuvant imatinib therapy in improving surgical outcomes for GIST, suggesting a potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Preoperative histologically confirmed primary gastrointestinal stromal tumor * Tumor must stain positive for c-Kit (CD117) and/or discovered on gist-1 (DOG-1) by immunohistochemistry * Gene mutation test report including c-kit exons 9,11,13 and 17 and platelet-derived growth factor receptor alpha (PDGFRA) exons 12 and 18 * High risk GIST (as modified National Institutes of Health (NIH) 2008): stomach (maximum tumor diameter\> 10.0cm), nonstomach (maximum tumor diameter\> 5.0cm) * Gender is not limited. Age: ≥ 18 years and ≤ 80 years old * Performance status: Eastern Cooperative Oncology Group (ECOG) 0-1 * Patient had informed consent and signed a written consent form Exclusion Criteria: * Asp842Val (D842V) mutation in Exon 18 of PDGFRA gene, or wild type (c-kit exon 9,11,13,17, and PDGFRA Exon 12,18), or c-kit exon 9 mutation * Treated with tyrosine kinase inhibitors including Imatinib * Aspartate aminotransferase (AST) and/or Alanine aminotransferase (ALT)\>2.5×ULN(upper limit of normal)，or Total bilirubin (TBIL)\>1.5×ULN，or Creatinine (Cr)\>1.0×ULN * Absolute neutrophil count (ANC) \< 1.5 × 10 \^ 9 / L；or Platelet count (PLT) \< 75 × 10 \^ 9 / L；or Hemoglobin (Hb) ≥ 90 g / L * Previous or concurrent other active malignant tumors (except for basal cell carcinoma of the skin, or cervical cancer in situ that has undergone curative therapy) * Distant metastases are present * Any of the following conditions during the 12 months prior to entry: myocardial infarction, severe / unstable angina, coronary artery / peripheral artery bypass surgery, symptomatic congestive heart failure, or cerebrovascular accidents * positive Human Immunodeficiency Virus (HIV) antibody * Currently participating in other clinical trials * Pregnant or lactating women or have fertility without taking contraception * Suffering from other serious acute and chronic physical or mental problems, or abnormal laboratory tests, will increase the risk of participation or drug use, or interfere with the judgment of the findings, judged by the researchers as participate in the study
Where this trial is running
Hangzhou, Zhejiang
- The First Affiliated Hospital, College of Medicine, Zhejiang University — Hangzhou, Zhejiang, China (Recruiting)
Study contacts
- Principal investigator: Jiren Yu — Zhejiang University
- Study coordinator: Weili Yang, Doctor
- Email: yangweili@zju.edu.cn
- Phone: +8613989879196
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.