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

NCT06038552 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 238

Last updated 2025-02-26

No results posted yet for this study

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).

Conditions

  • GIST, Malignant
  • Liver Metastases

Interventions

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.

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.

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 .

Sponsors & Collaborators

  • First Affiliated Hospital, Sun Yat-Sen University

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-01-01
Primary Completion
2022-12-31
Completion
2023-05-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06038552 on ClinicalTrials.gov