NCT03424876

To Compare the Efficacy of Surgery Followed by Sunitinib With Surgery Followed by Imatinib in GIST Patients With Progression on Imatinib.

A Retrospective Cohort Study

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 60 (estimated)
• Sponsor: Peking University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To compare the efficacy of surgery followed by sunitinib with surgery followed by imatinib in GIST patients with progression on imatinib;To investigate the optimal therapy after surgery in GIST patients with focal or multifocal progression in imatinib

Detailed description

Primary Endpoint: To evaluate the progression free survival of the patients with progression receiving surgery followed by sunitinib therapy comparing with surgery followed by imatinib Secondary Endpoint：To evaluate the overall survival of the patients with progression receiving surgery followed by sunitinib therapy comparing with surgery followed by imatinib the relationship of c-kit secondary mutation and progression free survival of surgery followed by TKI therapy the safety and tolerability of the two therapy. Statistics:All the statistical analysis is performed using SPSS version 20.0 (IBM corporation, United States). Pearson's chi-squared test was used to compare categorical variables. PFS and OS analyses were estimated with Kaplan-Meier method and log-rank test and multivariable analyses were performed to assess survival difference. A two sided p-value of \<0.05 was considered statistically significant.

Conditions

• GIST

Interventions

Type	Name	Description
DRUG	Imatinib 400mg	exposure 400 mg/day or 600mg/day,
DRUG	Sunitinib 37.5Mg Oral Capsule	exposure 37.5 mg/day, continuous taking, or 50 mg/day (4/2)

Timeline

• Start date: 2017-06-02
• Primary completion: 2018-06-02
• Completion: 2018-08-08
• First posted: 2018-02-07
• Last updated: 2018-03-01

Locations

1 site across 1 country: China