Actively Recruiting

Phase 2
Age: 18Years - 80Years
All Genders
NCT04933669

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

Led by First Affiliated Hospital of Zhejiang University · Updated on 2021-10-12

122

Participants Needed

1

Research Sites

433 weeks

Total Duration

On this page

Sponsors

F

First Affiliated Hospital of Zhejiang University

Lead Sponsor

S

Second Affiliated Hospital, School of Medicine, Zhejiang University

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Preoperative histological confirmation of primary gastrointestinal stromal tumor
  • Tumor positive for c-Kit (CD117) and/or DOG-1 by immunohistochemistry
  • Gene mutation test report including c-kit exons 9, 11, 13, 17 and PDGFRA exons 12 and 18
  • High risk GIST according to modified NIH 2008: stomach tumors > 10.0 cm, non-stomach tumors > 5.0 cm
  • Age between 18 and 80 years
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1
  • Signed informed consent form
Not Eligible

You will not qualify if you...

  • PDGFRA gene mutation Asp842Val (D842V) in Exon 18, wild type c-kit (exons 9, 11, 13, 17) and PDGFRA (exons 12, 18), or c-kit exon 9 mutation
  • Prior treatment with tyrosine kinase inhibitors including imatinib
  • AST and/or ALT > 2.5 times upper limit of normal, or total bilirubin > 1.5 times upper limit, or creatinine > 1.0 times upper limit
  • Absolute neutrophil count < 1.5 × 10^9/L, platelet count < 75 × 10^9/L, or hemoglobin < 90 g/L
  • Previous or concurrent malignant tumors except basal cell carcinoma of skin or treated cervical cancer in situ
  • Presence of distant metastases
  • History within 12 months of myocardial infarction, severe or unstable angina, coronary or peripheral artery bypass, symptomatic congestive heart failure, or cerebrovascular accidents
  • Positive HIV antibody test
  • Currently participating in other clinical trials
  • Pregnant or lactating women or women of childbearing potential not using contraception
  • Serious acute or chronic physical or mental conditions or abnormal lab tests that increase risk or interfere with study participation, as judged by researchers

AI-Screening

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Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

The First Affiliated Hospital, College of Medicine, Zhejiang University

Hangzhou, Zhejiang, China, 310003

Actively Recruiting

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Research Team

W

Weili Yang, Doctor

CONTACT

J

Jiren Yu

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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