5 years of imatinib treatment for high-risk gastrointestinal stromal tumors

A Phase 2 Study of 5 Years of Adjuvant Imatinib in Patients With Gastrointestinal Stromal Tumor With a High Risk of Recurrence Following Surgical Resection

This study is testing if taking imatinib for five years after surgery can help people with high-risk gastrointestinal stromal tumors avoid their cancer coming back.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 35 (estimated)
• Ages: 20 Years and up
• Sex: All
• Sponsor: Asan Medical Center (Academic / other)
• Drugs / interventions: imatinib
• Locations: 1 site (Seoul, Seoul)
• Trial ID: NCT05385549 on ClinicalTrials.gov

What this trial studies

This study investigates the efficacy and safety of administering adjuvant imatinib for five years to patients with high-risk gastrointestinal stromal tumors (GISTs) following surgical resection. It focuses on patients with tumor rupture or those with large tumors and a high mitotic index. The study aims to improve recurrence-free survival rates by evaluating the long-term effects of imatinib, a tyrosine-kinase inhibitor, on these patients. The research builds on previous findings that suggest adjuvant imatinib can enhance outcomes for GIST patients at high risk of recurrence.

Who should consider this trial

Good fit: Ideal candidates include adults aged 20 and older with histologically confirmed high-risk GISTs who have undergone complete surgical resection.

Not a fit: Patients with low-risk GISTs or those who have not undergone surgical resection may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce the recurrence of gastrointestinal stromal tumors in high-risk patients.

How similar studies have performed: Previous studies have shown that adjuvant imatinib can improve outcomes in GIST patients, indicating a promising approach for this high-risk population.

Eligibility criteria

Inclusion Criteria:

1. Age 20 years or older, at the time of acquisition of informed consent
2. Histologically confirmed GIST with CD117(+), DOG-1(+), or mutation in KIT or PDGFRα gene
3. (1) Completely resected localized GIST (R0 resection) within 12 weeks prior to the start of the adjuvant imatinib.

(2) After complete resection(R0 resection), High risk GIST according to Modified NIH criteria and ongoing adjuvant imatinib treatment.

4\) High risk GIST according to Modified NIH criteria,

1. Tumor rupture according to Nishida classification or
2. tumor size \>10cm and mitosis \>10/50 HPF 5) Eastern Cooperative Oncology Group (ECOG) performance status 0 \~ 2 6) Adequate bone marrow, hepatic, renal, and other organ functions, before adjuvant imatinib treatment

   * Neutrophil \>1,500/mm3
   * Platelet \> 100,000/mm3
   * Hemoglobin \>8.0 g/dL
   * Total bilirubin \< 1.5 x upper limit of normal (ULN)
   * AST/ALT \< 2.5 x ULN
   * Creatinine \<1.5 x ULN 7) Provision of a signed written informed consent

Exclusion Criteria:

1. Women of child-bearing potential who are pregnant or breast feeding
2. Women or men who are not willing to use effective contraception entering the study period or until at least 3 months after the last study drug administration.
3. If any of the following applies within ≤ 6 months prior to starting study enrollment : Myocardial Infarction, severe instable angina, coronary/peripheral bypass, NYHA class III or IV congestive heart failure, stroke or transient ischemic attack, treatment required severe arrhythmia.
4. Uncontrolled infection
5. Acute and chronic liver disease and all chronic liver impairment.(But Patients with stable chronic hepatitis B are eligible)
6. Patients who had reduced the dose of imatinib to less than 300 mg/day due to toxicity.
7. Acute, or chronic medical or psychiatric condition or laboratory abnormality such as active uncontrolled infection that difficult to study participation in the judgment of the investigator
8. Known diagnosis of HIV infection (HIV testing is not mandatory).
9. History of another primary malignancy that is currently clinically significant or currently requires active intervention.
10. Alcohol or substance abuse disorder.
11. The patients with PDGFRα D842V mutation

Where this trial is running

Seoul, Seoul

• Asan Medical Center, University of Ulsan College of Medicine — Seoul, Seoul, South Korea (Recruiting)

Study contacts

• Study coordinator: Ryu Min-Hee, MD, PhD

Conditions Gastrointestinal Stromal Tumors