Comparison of Clinical Efficacy of Liver Resection, RFA, TACE, and Drug Therapy in Patients with GIST LM

Comparison of Clinical Efficacy of Liver Resection, Radiofrequency Ablation, Transarterial Chemoembolization, and Drug Therapy in Patients with Liver Metastasis of Gastrointestinal Stromal Tumors

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).

Study Overview

• Status: Completed
• Conditions: Liver Metastases; GIST, Malignant
• Intervention / Treatment: Drug: imatinib (IM); Procedure: hepatic resection (HR); Procedure: radiofrequency ablation (RFA); Procedure: transarterial chemoembolization (TACE)

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 Type: Observational
• Enrollment (Actual): 238

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China
      • The First Affiliated Hospital of Sun Yat-sen University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

From January 2002 to April 2022, 330 consecutive patients were diagnosed with GIST liver metastases. Finally, a total of 238 patients were enrolled in our study. The patients were segregated into different treatment categories: IM therapy (n=126), IM combined with HR (n=81) and IM combined with RFA/TACE (n=31).

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	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: Gleevec
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: Gleevec; 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.
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: Gleevec; 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 .

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival	Overall survival (OS) was the span between GIST liver metastases diagnosis and the date of death.	up to 200 months

Collaborators and Investigators

• Sponsor: First Affiliated Hospital, Sun Yat-Sen University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2002
• Primary Completion (Actual): December 31, 2022
• Study Completion (Actual): May 1, 2023

Study Registration Dates

• First Submitted: September 5, 2023
• First Submitted That Met QC Criteria: September 12, 2023
• First Posted (Actual): September 15, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 24, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Neoplastic Processes; Neoplasm Metastasis; Tyrosine Kinase Inhibitors; Antineoplastic Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protein Kinase Inhibitors; Imatinib Mesylate
• Other Study ID Numbers: No.[2023]352

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No