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

• Conditions: GIST
• Interventions: Drug: Imatinib 400mg; Drug: Sunitinib 37.5Mg Oral Capsule

• Registration Number: NCT03424876
• Lead Sponsor: Peking University

Brief 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.

Study Timeline

• Study Start: 2017-06-02
• Study First Submitted: 2018-01-03
• Study First Submitted QC: 2018-01-31
• Status Verified: 2018-02
• Study First Posted: 2018-02-07
• Last Update Submitted: 2018-02-28
• Last Update Posted: 2018-03-01
• Primary Completion: 2018-06-02
• Study Completion: 2018-08-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. .Histopathological diagnosis of metastatic GIST.
2. . After the treatment of imatinib, imatinib 400mg/day after treatment, the tumor generalized.
3. . Patients with generalized progress were satisfied with tumor reduction after imatinib resistance for various reasons.
4. at least 1 month after surgery for imatinib treatment or sunitinib treatment.
5. at least one imaging assessment was received after surgery.
6. . Complete clinical data and follow-up data.

Exclusion Criteria

1. . Before operation, he was treated with sunitinib
2. . Patients receiving tumor reduction were not satisfied with the standard of the reduction of tumor.
3. . The treatment of imatinib or sunitinib after surgery was less than 1 month.
4. . Incomplete clinical data or follow-up data.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Arm A	Imatinib 400mg	Imatinib 400 mg/day or 600mg/day, and within 6 weeks after surgery, continuous treatment was not tolerated until tumor progression, recurrence or adverse reactions were not tolerated.
Arm B	Sunitinib 37.5Mg Oral Capsule	Sunitinib 37.5 mg/day, continuous taking, or 50 mg/day (4/2), began within 6 weeks after surgery, and was continuously administered until tumor progression, recurrence or adverse reactions were not tolerated

Primary Outcome Measures

Name	Time	Method
Security	12 months	Clinical and laboratory toxicity/symptoms will be graded according to the nci-ctc toxicity criteria.
Molecular marker detection	12 months	Gene mutation of c-kit/PDGFRA of imatinib resistance
Efficiency	12 months	The curative effect was evaluated by measuring the unprogression-survival (PFS) each treatment group.

Trial Locations

Locations (1)

Beijing Cancer Hospital; 🇨🇳 Beijing, Beijing, China