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

NCT04933669 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 122

Last updated 2021-10-12

No results posted yet for this study

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.

Conditions

  • Progression-free Survival
  • Gastrointestinal Stromal Tumor
  • Neoadjuvant

Interventions

DRUG

Imatinib

Imatinib neoadjuvant therapy

Sponsors & Collaborators

  • Second Affiliated Hospital, School of Medicine, Zhejiang University

    collaborator OTHER

  • Sir Run Run Shaw Hospital

    collaborator OTHER

  • Zhejiang Cancer Hospital

    collaborator OTHER

  • First Affiliated Hospital of Wenzhou Medical University

    collaborator OTHER

  • Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University

    collaborator OTHER

  • Ningbo No. 1 Hospital

    collaborator OTHER

  • First Affiliated Hospital of Zhejiang University

    lead OTHER

Principal Investigators

  • Jiren Yu · Zhejiang University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-07
Primary Completion
2029-12-31
Completion
2029-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04933669 on ClinicalTrials.gov