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Role of Surgery in Patients With Focally Progressive Gastrointestinal Stromal Tumors (GISTs) After Imatinib Treatment

Surgery Clinical Trial

Official title:
Role of Surgery in Patients With Focally Progressive Gastrointestinal Stromal Tumors (GISTs) After Imatinib Treatment: A Prospective, Multicenter, Randomized Trial

Clinical Trial Summary

This study evaluates the efficacy and safety of surgical intervention in patients with focally progressive GISTs after imatinib treatment. The enrolled patients will be randomized to receive surgery following imatinib 400 milligram per day (MG/d) or only tyrosine kinase inhibitor (Imatinib 600 MG/d or Sunitinib 37.5 MG/d).

Clinical Trial Description

Imatinib is the first-line treatment for advanced GIST with a satisfactory response rate, but complete remission rarely happens. Besides, drug resistance can occur during the treatment and the median time of drug resistance is about 20-24 months. Once drug resistance occurs, the patient's condition will progress rapidly. As a salvage treatment, the effect of increasing the dose of imatinib or switching to sunitinib is very limited. Progress after imatinib treatment usually involves two conditions, focal progression and extensive progression. For local progression, all resistant lesions can be completely resected; extensive progression refers to resistance progression in multiple sites, and progressive lesions cannot be completely removed. The present study is aimed to assess the benefits of surgical resection of imatinib-resistant lesions in patients with localized disease. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03862768
Study type Interventional
Source Shanghai Zhongshan Hospital
Contact
Status Not yet recruiting
Phase N/A
Start date July 2019
Completion date December 2021
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