Clinical trial NCT06038552: Comparison of Clinical Efficacy of Liver Resection, RFA, TACE, and Drug Therapy in Patients with GIST LM
Official title: Comparison of Clinical Efficacy of Liver Resection, Radiofrequency Ablation, Transarterial Chemoembolization, and Drug Therapy in Patients with Liver Metastasis of Gastrointestinal Stromal Tumors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: GIST, Malignant
Liver Metastases
Lead sponsor: First Affiliated Hospital, Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2023-09-15
Enrollment: 238
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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).

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.

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

Primary outcomes:
measure: Overall survival
timeFrame: up to 200 months
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Sun Yat-sen University
state: Guangdong
Study officials:
References: