Ripretinib Combined With Surgery in Advanced Gastrointestinal Stromal Tumors That Have Failed Imatinib Therapy: A Multicenter,Observational Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- 1-year Progression free survival rate
研究概览
简要总结
The objective of this observational study is to explore the efficacy and safety of ripretinib treatment combined with surgery in advanced gastrointestinal stromal tumors(GIST) after failure of imatinib therapy.
详细描述
This study is a single-arm, multicenter, observational study. A total of approximately 30 subjects were be enrolled. The patient was orally administered with ripretinib150 mg QD. 4 weeks for one cycle. Efficacy was assessed every two cycles. For subjects with PR or SD after ripretinib treatment, resection of gastrointestinal stromal tumor was performed after discussion by MDT and ensure R0 resection as much as possible.Ripretinib 150mg QD was continued 2 weeks after surgery. Thereafter, subjectss entered the follow-up period for at least 1 year. Safety and survival information will be collected
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients voluntarily, and signed a written informed consent, good compliance with follow-up;
- •18 years ≤ age < 75 years, male or female;
- •Histopathological examination confirmed the diagnosis of recurrent and/or metastatic advanced unresectable gastrointestinal stromal tumor;
- •According to the modified RECISTv1.1-GIST-specific criteria, the subject has at least one measurable lesion;
- •Subjects must have progressed on imatinib or have documented intolerance to imatinib.
- •ECOG PS of ≤ 2, ASA score ≤ 3 at screening;
- •No other malignant tumors occurred within five years;
排除标准
- •Molecular pathology report PDGFRA Exon 18 mutation(including D842v);
- •Patients with other serious complications who cannot tolerate surgery: such as severe cardiopulmonary disease, heart function below clinical class 2, pulmonary infection, moderate to severe COPD, chronic bronchitis, severe diabetes and/or renal insufficiency, severe hepatitis and/or Child-pugh class C or B whose symptoms are significantly difficult to correct, severe malnutrition, etc;
- •Pregnant or lactating women;
- •Treatment with any other line of therapy in addition to imatinib for advanced GIST. Imatinib-containing combination therapy in the first-line treatment should not be enrolled.
- •Subject has known active central nervous system metastases.
- •Occurrence of bleeding, perforation, obstruction and other disease-related complications, requiring emergency surgery;
- •The patient has participated in or is participating in other clinical studies , or is taking other TKI agents;
结局指标
主要结局
1-year Progression free survival rate
时间窗: 12 monthes
PFS Based on radiographic assessment using Choi criteria
次要结局
- Duration of continuous medication before surgery(12 monthes)
- objective response rate（ORR）(12 monthes)
- 2-year overall survival rate(24 monthes)
- time to progression (TTP)(12 monthes)
- R0 resection rate(1 days after surgery)
研究者
Minghui Pang
Professor
Sichuan Provincial People's Hospital