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

NCT05385549 | Recruiting Phase 2

• 1 other identifier: AMC2202
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

In this study, the investigators aim to investigate the efficacy and safety of 5 years of adjuvant imatinib treatment in patients with tumor rupture defined by Nishida classification or those with a tumor size 10cm or larger and a mitotic index of 10/50HPFs or higher.

Conditions

Gastrointestinal Stromal Tumors

Outcome Measures

Primary Outcomes (1)

• PFS

  Progression-free survival (PFS) per the RECIST v1.1 is defined as the time from the date of first dosing of Imatinib to the date of progression or death due to any cause

  up to 5years

Study Arms (1)

5 years of adjuvant imatinib treatment

EXPERIMENTAL

Drug: Imatinib Mesylate

Interventions

Imatinib Mesylate DRUG

Imatinib Mesylate, 400 mg once daily, oral. 5 years of adjuvant imatinib treatment (standard treatment 3years + IP treatment : 2yesrs)

5 years of adjuvant imatinib treatment

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 20 years or older, at the time of acquisition of informed consent
• Histologically confirmed GIST with CD117(+), DOG-1(+), or mutation in KIT or PDGFRα gene
• (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.
• \) High risk GIST according to Modified NIH criteria,
• Tumor rupture according to Nishida classification or
• 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

You may not qualify if:

• Women of child-bearing potential who are pregnant or breast feeding
• 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.
• 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.
• Uncontrolled infection
• Acute and chronic liver disease and all chronic liver impairment.(But Patients with stable chronic hepatitis B are eligible)
• Patients who had reduced the dose of imatinib to less than 300 mg/day due to toxicity.
• 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
• Known diagnosis of HIV infection (HIV testing is not mandatory).
• History of another primary malignancy that is currently clinically significant or currently requires active intervention.
• Alcohol or substance abuse disorder.
• The patients with PDGFRα D842V mutation

Sponsors & Collaborators

• Asan Medical Center: lead

Study Sites (1)

Asan Medical Center, University of Ulsan College of Medicine

Seoul, Seoul, 138-736, South Korea

RECRUITING

MeSH Terms

Conditions

Gastrointestinal Stromal Tumors

Interventions

Imatinib Mesylate

Condition Hierarchy (Ancestors)

Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Benzamides; Amides; Organic Chemicals; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines

Central Study Contacts

Ryu Min-Hee, MD, PhD

CONTACT

82-2-3010-5936; miniryu@amc.seoul.kr

Kang Yoon-Koo, MD, PhD

CONTACT

82-2-3010-3230; ykkang@amc.seoul.kr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 18, 2022
• First Posted: May 23, 2022
• Study Start: September 7, 2022
• Primary Completion (Estimated): April 30, 2030
• Study Completion (Estimated): April 30, 2030
• Last Updated: August 8, 2025

Record last verified: 2025-08

Locations

KR (1)