The Long-term Efficacy of Imatinib With Hepatic Resection or Other Local Treatment for GIST Liver Metastases
Study Details
Study Description
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:
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IM group
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IM combined with HR group
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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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| IM group Imatinib(IM) |
Drug: imatinib (IM)
Patients with GIST liver metastases were administered an initial IM dose of 400 mg daily, while those with KIT exon 9 mutations received 600-800 mg daily. All patients continued IM indefinitely unless progression or intolerable adverse reactions.
Other Names:
|
| IM combined with HR group Imatinib(IM) combined with hepatic resection(HR) |
Drug: imatinib (IM)
Patients with GIST liver metastases were administered an initial IM dose of 400 mg daily, while those with KIT exon 9 mutations received 600-800 mg daily. All patients continued IM indefinitely unless progression or intolerable adverse reactions.
Other Names:
Procedure: hepatic resection (HR)
HR The determination of the surgical modality was established subsequent to comprehensive consultations tailored to each patient within the Department of Liver Surgery. The surgical strategy was established in consideration of factors such as the residual liver volume, tumour positioning, and the surgeon's personal preference. Employing an intraoperative ultrasonographic to enhance the precision of operative assessment.
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| IM combined with RFA or TACE group Imatinib(IM) combined with radiofrequency ablation (RFA) or transarterial chemoembolization (TACE) |
Drug: imatinib (IM)
Patients with GIST liver metastases were administered an initial IM dose of 400 mg daily, while those with KIT exon 9 mutations received 600-800 mg daily. All patients continued IM indefinitely unless progression or intolerable adverse reactions.
Other Names:
Procedure: radiofrequency ablation (RFA)
RFA RFA was executed utilizing the commercially accessible Cool-tip™ RFA system or the RF 2000 system. The electrode was percutaneously inserted through a guide needle under real-time ultrasound guidance.The primary objective of the RFA procedures encompassed the complete elimination of the tumour entity, with a prescribed ablative margin of 0.5 cm meticulously factored in.
Procedure: transarterial chemoembolization (TACE)
TACE Under a comprehensive assessment of the hepatic arterial blood supply, a selective catheter was introduced into the segmental or subsegmental arteries that supplied the tumour. The regimen of hepatic arterial infusion chemotherapy included infusion of carboplatin 300 mg, a mixture of 50 mg of epirubicin and 8 mg of mitomycin C, intimately blended with 5 mL of lipiodol. Embolization was finally performed with either absorbable gelatin sponge particles or polyvinyl alcohol particles .
|
Outcome Measures
Primary Outcome Measures
- Overall survival [up to 200 months]
Overall survival (OS) was the span between GIST liver metastases diagnosis and the date of death.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Pathological evidence of GIST of primary tumors
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Liver metastases evidenced by biopsy or radiological findings
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Sufficient liver, hematologic, and renal function, coupled with an Eastern Cooperative Oncology Group performance status score ranging from 0 to 1
Exclusion Criteria:
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IM was not used during treatment
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Liver metastases appeared on second-line or later subsequent lines of TKI
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Combined with other malignant tumors
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Failure to follow up
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | The First Affiliated Hospital of Sun Yat-sen University | Guangzhou | Guangdong | China |
Sponsors and Collaborators
- First Affiliated Hospital, Sun Yat-Sen University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- No.[2023]352