ZJGIST-01: Prospective Multicenter Clinical Study of Neoadjuvant Imatinib Mesylate for Gastrointestinal Stromal Tumors

Sponsor
First Affiliated Hospital of Zhejiang University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04933669
Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University (Other), Sir Run Run Shaw Hospital (Other), Zhejiang Cancer Hospital (Other), First Affiliated Hospital of Wenzhou Medical University (Other), Taizhou Hospital of Zhejiang Province (Other), Ningbo No. 1 Hospital (Other)
122
1
1
99.8
1.2

Study Details

Study Description

Brief Summary

The R0 resection rate of gastrointestinal stromal tumor (GIST) with high recurrence risk was relatively low, and the relapse-free survival rate was relatively low, which needed to be further improved. A few retrospective analyses and a small sample of prospective studies have found that neoadjuvant therapy with imatinib mesylate can improve R0 resection rates. Whether neoadjuvant therapy prolongs long-term survival remains unclear. The primary objective of this study was to evaluate 5-year progression-free survival (PFS) for GIST patients with high recurrence risk after neoadjuvant treatment with imatinib mesylate.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
122 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Prospective Multicenter Clinical Study of Neoadjuvant Imatinib Mesylate for Gastrointestinal Stromal Tumors
Actual Study Start Date :
Sep 7, 2021
Anticipated Primary Completion Date :
Dec 31, 2029
Anticipated Study Completion Date :
Dec 31, 2029

Arms and Interventions

Arm Intervention/Treatment
Experimental: Imatinib neoadjuvant

Patients receive oral imatinib mesylate 400mg once daily for 3-12 months in the absence of disease progression or unacceptable toxicity. Within 1 week after completion of preoperative imatinib mesylate, patients with responding or stable disease undergo surgical resection. After complete resection, patients receive oral imatinib mesylate 400mg once daily for 36 months in the absence of disease progression or unacceptable toxicity, and are followed for 5 years.

Drug: Imatinib
Imatinib neoadjuvant therapy
Other Names:
  • neoadjuvant therapy
  • Outcome Measures

    Primary Outcome Measures

    1. Progression free survival(PFS) [5 years]

      Progression free survival(PFS)

    Secondary Outcome Measures

    1. Overall survival(OS) [5 years]

      Overall survival(OS)

    2. Objective Response Rate (ORR) [Up to 1 year]

      Rate of complete and partial response according to Choi criteria

    3. R0 resection rate [Up to 1 year]

      complete resection rate with microscopically negative margin

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The First Affiliated Hospital, College of Medicine, Zhejiang University Hangzhou Zhejiang China 310003

    Sponsors and Collaborators

    • First Affiliated Hospital of Zhejiang University
    • Second Affiliated Hospital, School of Medicine, Zhejiang University
    • Sir Run Run Shaw Hospital
    • Zhejiang Cancer Hospital
    • First Affiliated Hospital of Wenzhou Medical University
    • Taizhou Hospital of Zhejiang Province
    • Ningbo No. 1 Hospital

    Investigators

    • Principal Investigator: Jiren Yu, Zhejiang University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Yu jiren, Chief of Gastrointestinal Surgery, First Affiliated Hospital of Zhejiang University
    ClinicalTrials.gov Identifier:
    NCT04933669
    Other Study ID Numbers:
    • IIT20210023C-R1
    First Posted:
    Jun 22, 2021
    Last Update Posted:
    Oct 12, 2021
    Last Verified:
    Oct 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by Yu jiren, Chief of Gastrointestinal Surgery, First Affiliated Hospital of Zhejiang University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 12, 2021