Comparison of Clinical Efficacy of Liver Resection, Radiofrequency Ablation, Transarterial Chemoembolization, and Drug Therapy in Patients with Liver Metastasis of Gastrointestinal Stromal Tumors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 238
- 试验地点
- 1
- 主要终点
- Overall survival
研究概览
简要总结
The goal of this observational study is to evaluate the overall survival benefits of local treatment combined with imatinib(IM) and IM alone in patients suffering from GIST liver metastases. The main question it aims to answer is:
• Whether IM combined with hepatic resection (HR) or other local treatments such as radiofrequency ablation (RFA) and transarterial chemoembolization (TACE) has better long-term survival benefits compared to IM monotherapy.
Patients are divided into different treatment groups:
- IM group
- IM combined with HR group
- IM combined with RFA or TACE group
Researchers will compare the IM + HR group and IM + RFA/TACE group with the IM group to see if it has a better Overall survival (OS).
详细描述
Gastrointestinal stromal tumors (GISTs) represent the most prevalent type of mesenchymal tumor within the gastrointestinal tract, and the liver is the most common site of metastasis from GIST. Imatinib (IM) has significantly enhanced clinical outcomes for patients with advanced disease. Since its approval in February 2002 for treating metastatic or unresectable GISTs, 38% of patients have shown a partial response, while 13.6% have experienced disease progression within 1 to 3 months of IM administration. Over half of the patients with metastases experienced disease progression within two years of IM treatment, attributed to secondary drug resistance. Few studies are comparing the survival benefits of different surgical modalities. The investigators aimed to evaluate IM combined with hepatic resection (HR) or other local treatments such as radiofrequency ablation (RFA) and transarterial chemoembolization (TACE), compared to IM monotherapy in long-term survival benefits in patients suffering from GIST liver metastases.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Pathological evidence of GIST of primary tumors
- •Liver metastases evidenced by biopsy or radiological findings
- •Sufficient liver, hematologic, and renal function, coupled with an Eastern Cooperative Oncology Group performance status score ranging from 0 to 1
排除标准
- •IM was not used during treatment
- •Liver metastases appeared on second-line or later subsequent lines of TKI
- •Combined with other malignant tumors
- •Failure to follow up
研究组 & 干预措施
IM group
Imatinib(IM)
干预措施: imatinib (IM) (Drug)
IM combined with HR group
Imatinib(IM) combined with hepatic resection(HR)
干预措施: imatinib (IM) (Drug)
IM combined with HR group
Imatinib(IM) combined with hepatic resection(HR)
干预措施: hepatic resection (HR) (Procedure)
IM combined with RFA or TACE group
Imatinib(IM) combined with radiofrequency ablation (RFA) or transarterial chemoembolization (TACE)
干预措施: imatinib (IM) (Drug)
IM combined with RFA or TACE group
Imatinib(IM) combined with radiofrequency ablation (RFA) or transarterial chemoembolization (TACE)
干预措施: radiofrequency ablation (RFA) (Procedure)
IM combined with RFA or TACE group
Imatinib(IM) combined with radiofrequency ablation (RFA) or transarterial chemoembolization (TACE)
干预措施: transarterial chemoembolization (TACE) (Procedure)
结局指标
主要结局
Overall survival
时间窗: up to 200 months
Overall survival (OS) was the span between GIST liver metastases diagnosis and the date of death.
次要结局
未报告次要终点
研究者
Xinhua Zhang, MD
Deputy Director
First Affiliated Hospital, Sun Yat-Sen University