Prospective Multicenter Clinical Study of Neoadjuvant Imatinib Mesylate for Gastrointestinal Stromal Tumors
ZJGIST-01
1 other identifier
interventional
122
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Sep 2021
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 9, 2021
CompletedFirst Posted
Study publicly available on registry
June 22, 2021
CompletedStudy Start
First participant enrolled
September 7, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2029
October 12, 2021
October 1, 2021
8.3 years
June 9, 2021
October 9, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression free survival（PFS）
Progression free survival（PFS）
5 years
Secondary Outcomes (3)
Overall survival（OS）
5 years
Objective Response Rate （ORR）
Up to 1 year
R0 resection rate
Up to 1 year
Study Arms (1)
Imatinib neoadjuvant
EXPERIMENTALPatients 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- First Affiliated Hospital of Zhejiang Universitylead
- Second Affiliated Hospital, School of Medicine, Zhejiang Universitycollaborator
- Sir Run Run Shaw Hospitalcollaborator
- Zhejiang Cancer Hospitalcollaborator
- First Affiliated Hospital of Wenzhou Medical Universitycollaborator
- Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical Universitycollaborator
- Ningbo No. 1 Hospitalcollaborator
Study Sites (1)
The First Affiliated Hospital, College of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310003, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jiren Yu
Zhejiang University
Central Study Contacts
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
- Chief of Gastrointestinal Surgery
Study Record Dates
First Submitted
June 9, 2021
First Posted
June 22, 2021
Study Start
September 7, 2021
Primary Completion (Estimated)
December 31, 2029
Study Completion (Estimated)
December 31, 2029
Last Updated
October 12, 2021
Record last verified: 2021-10
Data Sharing
- IPD Sharing
- Will not share