Using Imatinib Mesylate before surgery for gastrointestinal stromal tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the effectiveness of neoadjuvant therapy with imatinib mesylate in patients with high-risk gastrointestinal stromal tumors (GIST). The primary goal is to assess the 5-year progression-free survival rate following treatment. Participants must have a histologically confirmed GIST that tests positive for specific genetic markers and meet certain size criteria. The study aims to improve surgical outcomes and long-term survival rates for these patients.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Preoperative histologically confirmed primary gastrointestinal stromal tumor
* Tumor must stain positive for c-Kit (CD117) and/or discovered on gist-1 (DOG-1) by immunohistochemistry
* Gene mutation test report including c-kit exons 9,11,13 and 17 and platelet-derived growth factor receptor alpha (PDGFRA) exons 12 and 18
* High risk GIST (as modified National Institutes of Health (NIH) 2008): stomach (maximum tumor diameter\> 10.0cm), nonstomach (maximum tumor diameter\> 5.0cm)
* Gender is not limited. Age: ≥ 18 years and ≤ 80 years old
* Performance status: Eastern Cooperative Oncology Group (ECOG) 0-1
* Patient had informed consent and signed a written consent form

Exclusion Criteria:

* Asp842Val (D842V) mutation in Exon 18 of PDGFRA gene, or wild type (c-kit exon 9,11,13,17, and PDGFRA Exon 12,18), or c-kit exon 9 mutation
* Treated with tyrosine kinase inhibitors including Imatinib
* Aspartate aminotransferase (AST) and/or Alanine aminotransferase (ALT)\>2.5×ULN(upper limit of normal)，or Total bilirubin (TBIL)\>1.5×ULN，or Creatinine (Cr)\>1.0×ULN
* Absolute neutrophil count (ANC) \< 1.5 × 10 \^ 9 / L；or Platelet count (PLT) \< 75 × 10 \^ 9 / L；or Hemoglobin (Hb) ≥ 90 g / L
* Previous or concurrent other active malignant tumors (except for basal cell carcinoma of the skin, or cervical cancer in situ that has undergone curative therapy)
* Distant metastases are present
* Any of the following conditions during the 12 months prior to entry: myocardial infarction, severe / unstable angina, coronary artery / peripheral artery bypass surgery, symptomatic congestive heart failure, or cerebrovascular accidents
* positive Human Immunodeficiency Virus (HIV) antibody
* Currently participating in other clinical trials
* Pregnant or lactating women or have fertility without taking contraception
* Suffering from other serious acute and chronic physical or mental problems, or abnormal laboratory tests, will increase the risk of participation or drug use, or interfere with the judgment of the findings, judged by the researchers as participate in the study

Where it's running

• The First Affiliated Hospital, College of Medicine, Zhejiang University
  Hangzhou, Zhejiang, China Recruiting

Study contacts

• Principal investigator: Jiren Yu — Zhejiang University
• Study coordinator: Weili Yang, Doctor
• Email: yangweili@zju.edu.cn
• Phone: +8613989879196

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Velzatinib for advanced GIST after multiple prior TKIs

  This study tests velzatinib to see if it can shrink or slow tumors in people with metastatic or unresectable GIST who have progressed on or could not tolerate standard therapies.

  Recruiting at 3 sites Phase 2 GlaxoSmithKline · Fukuoka and 2 other locations · NCT07689201

• Velzatinib vs. Imatinib as frontline treatment for metastatic or unresectable GIST

  This trial tests velzatinib against imatinib as the first systemic therapy for adults with newly diagnosed metastatic or unresectable gastrointestinal stromal tumors to see if velzatinib can delay progression and be tolerable.

  Recruiting at 93 sites Phase 3 GlaxoSmithKline · Scottsdale, Arizona and 92 other locations · NCT07585266

• Imatinib added to artemether-lumefantrine for uncomplicated P. falciparum malaria

  This trial tests whether adding imatinib to standard artemether-lumefantrine helps people with uncomplicated Plasmodium falciparum malaria clear infections faster and limit drug-resistant parasites.

  Recruiting Phase 2 Victoria Biomedical Research Institute · Kisumu · NCT07559370

• Pemigatinib for advanced SDH‑deficient GIST

  This trial will try the oral drug pemigatinib in adults with advanced SDH‑deficient GIST to see if it controls tumor growth and what side effects occur.

  Recruiting Phase 2 Dana-Farber Cancer Institute · Boston, Massachusetts · NCT07434843

• KQB198 plus imatinib for first-line advanced or metastatic GIST

  This Phase 2 test will see if adding the experimental drug KQB198 to imatinib helps people with advanced or metastatic GIST who are starting first-line treatment.

  Recruiting at 17 sites Phase 2 Kumquat Biosciences Inc. · Los Angeles, California and 16 other locations · NCT07406633

• Ivonescimab with albumin‑paclitaxel and cisplatin before surgery for esophageal squamous cell carcinoma

  This trial tests whether adding ivonescimab to albumin‑paclitaxel and cisplatin before surgery helps people with resectable, locally advanced esophageal squamous cell carcinoma.

  Recruiting Phase 1/2 Tang-Du Hospital · Xi'an, Shannxi · NCT07385001

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.