Gastrointestinal Stromal Tumor Clinical Trials

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

Who is this study for? Patients with Gastrointestinal Stromal Tumor
What treatments are being studied? Imatinib
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
China
The First Affiliated Hospital, College of Medicine, Zhejiang University
RECRUITING
Hangzhou
Contact Information
Primary
Weili Yang, Doctor
yangweili@zju.edu.cn
+8613989879196
Backup
Jiren Yu
yujr0909@zju.edu.cn
+8657187236147
Time Frame
Start Date: 2021-09-07
Estimated Completion Date: 2029-12-31
Participants
Target number of participants: 122
Treatments
Experimental: Imatinib neoadjuvant
Patients receive oral imatinib mesylate 400mg once daily for 3-12 months in the absence of disease progression or unacceptable toxicity. Within 1 week after completion of preoperative imatinib mesylate, patients with responding or stable disease undergo surgical resection. After complete resection, patients receive oral imatinib mesylate 400mg once daily for 36 months in the absence of disease progression or unacceptable toxicity, and are followed for 5 years.
Related Therapeutic Areas
Sponsors
Collaborators: Second Affiliated Hospital, School of Medicine, Zhejiang University, First Affiliated Hospital of Wenzhou Medical University, Zhejiang Cancer Hospital, Ningbo No. 1 Hospital, Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University, Sir Run Run Shaw Hospital
Leads: First Affiliated Hospital of Zhejiang University

This content was sourced from clinicaltrials.gov