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

NCT ID: NCT06038552

Last Updated: 2025-02-26

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 238 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2002-01-01
• Study Completion Date: 2023-05-01

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.

Conditions

GIST, Malignant; Liver Metastases

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

IM group

Imatinib(IM)

imatinib (IM)

Intervention Type: DRUG

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.

IM combined with HR group

Imatinib(IM) combined with hepatic resection(HR)

imatinib (IM)

Intervention Type: DRUG

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.

hepatic resection (HR)

Intervention Type: PROCEDURE

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)

imatinib (IM)

Intervention Type: DRUG

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.

radiofrequency ablation (RFA)

Intervention Type: PROCEDURE

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.

transarterial chemoembolization (TACE)

Intervention Type: PROCEDURE

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 .

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: 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.

Intervention Type: 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 .

Intervention Type: PROCEDURE

Other Intervention Names

Gleevec

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

First Affiliated Hospital, Sun Yat-Sen University

OTHER

Sponsor Role: lead

Responsible Party

Xinhua Zhang, MD

Deputy Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

The First Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

Countries

China

Other Identifiers

No.[2023]352

Identifier Type: -

Identifier Source: org_study_id