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

Sun Yat-sen University

Status: Completed

Conditions: Liver Metastases; GIST, Malignant

Treatments: Procedure: hepatic resection (HR); Drug: imatinib (IM); Procedure: transarterial chemoembolization (TACE); Procedure: radiofrequency ablation (RFA)

Study type: Observational

Funder types: Other

Identifiers

NCT06038552

No.[2023]352

Details and patient eligibility

About

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).

Full 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.

Enrollment: 238 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

238 participants in 3 patient groups

IM group

Description:

Imatinib(IM)

Treatment:

Drug: imatinib (IM)

IM combined with HR group

Description:

Imatinib(IM) combined with hepatic resection(HR)

Treatment:

Drug: imatinib (IM)

Procedure: hepatic resection (HR)

IM combined with RFA or TACE group

Description:

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

Treatment:

Procedure: radiofrequency ablation (RFA)

Procedure: transarterial chemoembolization (TACE)

Drug: imatinib (IM)