Prospective Multicenter Clinical Study of Neoadjuvant Imatinib Mesylate for Gastrointestinal Stromal Tumors

  • STATUS
    Recruiting
  • End date
    Dec 31, 2029
  • participants needed
    122
  • sponsor
    First Affiliated Hospital of Zhejiang University
Updated on 17 October 2021

Summary

The R0 resection rate of gastrointestinal stromal tumor (GIST) with high recurrence risk was relatively low, and the relapse-free survival rate was relatively low, which needed to be further improved. A few retrospective analyses and a small sample of prospective studies have found that neoadjuvant therapy with imatinib mesylate can improve R0 resection rates. Whether neoadjuvant therapy prolongs long-term survival remains unclear. The primary objective of this study was to evaluate 5-year progression-free survival (PFS) for GIST patients with high recurrence risk after neoadjuvant treatment with imatinib mesylate.

Details
Condition gastrointestinal stromal tumors, neoadjuvant treatment, Disease-Free Survival, Neoadjuvant Therapy, gastrointestinal stromal tumor, gist, induction therapy
Treatment Imatinib
Clinical Study IdentifierNCT04933669
SponsorFirst Affiliated Hospital of Zhejiang University
Last Modified on17 October 2021

Eligibility

Yes No Not Sure

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)>2.5ULN(upper limit of normal)or Total bilirubin (TBIL)>1.5ULNor Creatinine (Cr)>1.0ULN
Absolute neutrophil count (ANC) < 1.5 10 ^ 9 / Lor Platelet count (PLT) < 75 10 ^ 9 / Lor 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
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