Clinical trial · Interventional
Imatinib Mesylate in Treating Patients With Liver Metastasis From a Gastrointestinal Stromal Tumor
Phase II Multicenter Clinical Trial on Imatinib Treatment for Patients With Resectable Hepatic Metastasis From Gastrointestinal Stromal Tumors (GISTs)
NCT00764595CI-TRIAL-00068159GISTscompletedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Imatinib mesylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. PURPOSE: This phase II trial is studying the side effects of imatinib mesylate and to see how well it works in treating patients with liver metastasis from a gastrointestinal stromal tumor.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastrointestinal Stromal Tumor | Gastrointestinal Stromal Tumor | ONTOLOGY_EXACT | 0.98 |
| Metastatic Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| imatinib mesylate | Drug | Imatinib Mesylate | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- imatinib mesylate
- description
- All patients start imatinib mesylate as oral dose of 400 mg/d once daily after meal within 28 days after enrollment, and continue the treatment until 3 years after enrollment of the last patient.
- interventionNames
- Drug: imatinib mesylate
Primary outcomes (1)
- measure
- Progression-free survival
- timeFrame
- 7.5 years
- description
- Progression-free survival is defined as time from date of starting protocol treatment until date of comfirmation of progressive disease (PD) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.0 or death from any cause, whichever comes first.
Secondary outcomes (3)
- measure
- Tumor response
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Diagnosis of gastrointestinal stromal tumor (GIST) * Hepatic metastasis meeting the following criteria: * No more than 3 hepatic metastases * Clinically diagnosed as surgically resectable with no macroscopic residual tumor * Synchronous hepatic metastasis allowed provided primary tumor is also resectable * No metastatic tumor that requires radiofrequency ablation and/or microwave coagulation therapy to control the disease * No extrahepatic metastasis * No history of GIST recurrence PATIENT CHARACTERISTICS: * ECOG performance status 0-1 * Leukocyte count ≥ 3,000/μL * Neutrophil count ≥ 1,500/μL * Hemoglobin ≥ 8.0 g/dL * Platelet count ≥ 75,000/μL * Total bilirubin ≤ 2.0 mg/dL * ALT and AST \< 120 IU/L * GTP \< 210 IU/L * Not pregnant * No poorly controlled diabetes mellitus * No NYHA class III-IV cardiac function * No hepatitis B or hepatitis B carriers * No other malignancy requiring treatment PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No prior imatinib mesylate * No prior interventional radiology for metastatic disease * No other concurrent treatment, including surgery or radiotherapy, for metastatic lesions
References
Publications (0)
Data not yet available
No reference posted for this study.