What is imatinib studying for gastrointestinal stromal tumors?

Imatinib is being studied to see if taking it for 5 years after surgery can better prevent the return of high-risk gastrointestinal stromal tumors (GIST). Researchers want to find out if extending treatment helps patients with certain tumor features linked to higher recurrence risk. This study is led by Asan Medical Center to improve care for these patients.

Who may be eligible for this gastrointestinal stromal tumor clinical trial?

Adults aged 20 or older with a confirmed diagnosis of gastrointestinal stromal tumor (GIST) who have had complete tumor removal and meet high-risk criteria may be eligible. Both men and women can participate if they have good organ function and performance status. Please review eligibility criteria for more details.

Is there any cost to participate in this gastrointestinal stromal tumor clinical trial?

Study-related care, including the study drug and all trial visits, is provided at no cost. However, personal travel and other expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for any travel or accommodation costs.

Actively Recruiting

Phase 2

Age: 20Years +

All Genders

ID05385549

Phase 2 Study of 5 Years of Adjuvant Imatinib Treatment for High-Risk Gastrointestinal Stromal Tumor After Surgery

Led by Asan Medical Center · Updated on 2025-08-08

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are investigating the safety and effectiveness of 5 years of adjuvant imatinib treatment in patients with gastrointestinal stromal tumors GIST who have a high risk of recurrence. This includes patients with tumor rupture defined by Nishida classification or those with tumors 10cm or larger and a high mitotic index. The study builds on previous findings that showed benefits of shorter imatinib treatment durations and aims to improve long-term outcomes for high-risk patients. Participants will receive imatinib mesylate orally at a dose of 400 mg once daily for 5 years. This treatment extends the current standard 3-year adjuvant therapy by an additional 2 years. The study focuses on patients who have had complete surgical removal of their tumor and meet specific high-risk criteria. The trial is a phase 2, open-label study without randomization or placebo. Throughout the 5-year treatment period, participants will be monitored for progression-free survival as the primary outcome. Researchers will assess tumor status and overall health through regular visits and laboratory tests to evaluate safety and response. The study will also monitor organ function and patient performance status to ensure ongoing suitability for treatment. Participation may last up to 5 years, including follow-ups to observe long-term effects of the therapy.

CONDITIONS

Brief Title

5 Years of Adjuvant Imatinib in Patients With Gastrointestinal Stromal Tumor With a High Risk

Who Can Participate

Age: 20Years +

All Genders

Eligibility Criteria

You may qualify if you...

Age 20 years or older at the time of informed consent
Histologically confirmed GIST with CD117(+), DOG-1(+), or mutation in KIT or PDGFRα gene
Completely resected localized GIST (R0 resection) within 12 weeks prior to start of adjuvant imatinib
High risk GIST according to Modified NIH criteria with ongoing adjuvant imatinib treatment
Tumor rupture by Nishida classification or tumor size larger than 10 cm and mitotic count over 10/50 HPF
ECOG performance status of 0 to 2
Adequate bone marrow, liver, kidney, and other organ function
Signed written informed consent

You will not qualify if you...

Pregnant or breastfeeding women of child-bearing potential
Women or men unwilling to use effective contraception during the study and for 3 months after last drug dose
Recent (within 6 months) serious heart conditions including myocardial infarction, unstable angina, bypass surgery, severe heart failure, stroke, or severe arrhythmia
Uncontrolled infections
Acute or chronic liver disease or impairment (except stable chronic hepatitis B)
Previous imatinib dose reduced below 300 mg/day due to toxicity
Active uncontrolled medical or psychiatric conditions or lab abnormalities
Known HIV infection
History of other clinically significant primary malignancy requiring active treatment
Alcohol or substance abuse disorder
Patients with PDGFRα D842V mutation

Research Team

Ryu Min-Hee, MD, PhD

Kang Yoon-Koo, MD, PhD

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