Comparison of Clinical Efficacy of Liver Resection, RFA, TACE, and Drug Therapy in Patients with GIST LM
- Conditions
- GIST, MalignantLiver Metastases
- Interventions
- Procedure: hepatic resection (HR)Procedure: radiofrequency ablation (RFA)Procedure: transarterial chemoembolization (TACE)
- Registration Number
- NCT06038552
- Lead Sponsor
- First Affiliated Hospital, Sun Yat-Sen University
- Brief Summary
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).
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 238
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description IM combined with RFA or TACE group imatinib (IM) Imatinib(IM) combined with radiofrequency ablation (RFA) or transarterial chemoembolization (TACE) IM group imatinib (IM) Imatinib(IM) IM combined with HR group imatinib (IM) Imatinib(IM) combined with hepatic resection(HR) IM combined with HR group hepatic resection (HR) Imatinib(IM) combined with hepatic resection(HR) IM combined with RFA or TACE group radiofrequency ablation (RFA) Imatinib(IM) combined with radiofrequency ablation (RFA) or transarterial chemoembolization (TACE) IM combined with RFA or TACE group transarterial chemoembolization (TACE) Imatinib(IM) combined with radiofrequency ablation (RFA) or transarterial chemoembolization (TACE)
- Primary Outcome Measures
Name Time Method Overall survival up to 200 months Overall survival (OS) was the span between GIST liver metastases diagnosis and the date of death.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
The First Affiliated Hospital of Sun Yat-sen University
🇨🇳Guangzhou, Guangdong, China