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

NCT06038552 | Completed

• 1 other identifier: No.[2023]352
• Study Type: observational
• Target: 238
• Locations: 1 country
• Sites: 1

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).

Conditions

GIST, Malignant; Liver Metastases

Outcome Measures

Primary Outcomes (1)

• Overall survival

  Overall survival (OS) was the span between GIST liver metastases diagnosis and the date of death.

  up to 200 months

Study Arms (3)

IM group

Imatinib(IM)

Drug: imatinib (IM)

IM combined with HR group

Imatinib(IM) combined with hepatic resection(HR)

Drug: imatinib (IM); Procedure: hepatic resection (HR)

IM combined with RFA or TACE group

Imatinib(IM) combined with radiofrequency ablation (RFA) or transarterial chemoembolization (TACE)

Drug: imatinib (IM); Procedure: radiofrequency ablation (RFA); Procedure: transarterial chemoembolization (TACE)

Interventions

imatinib (IM) 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.

Also known as: Gleevec

IM combined with HR group; IM combined with RFA or TACE group; IM group

hepatic resection (HR) 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 HR group

radiofrequency ablation (RFA) 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.

IM combined with RFA or TACE group

transarterial chemoembolization (TACE) 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 .

IM combined with RFA or TACE group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

The First Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

Location

MeSH Terms

Conditions

Gastrointestinal Stromal Tumors

Interventions

Imatinib Mesylate; Radiofrequency Ablation

Condition Hierarchy (Ancestors)

Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Benzamides; Amides; Organic Chemicals; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines; Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Director

Study Record Dates

• First Submitted: September 5, 2023
• First Posted: September 15, 2023
• Study Start: January 1, 2002
• Primary Completion: December 31, 2022
• Study Completion: May 1, 2023
• Last Updated: February 26, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)