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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04933669
Other study ID # IIT20210023C-R1
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date September 7, 2021
Est. completion date December 31, 2029

Study information

Verified date October 2021
Source First Affiliated Hospital of Zhejiang University
Contact Weili Yang, Doctor
Phone +8613989879196
Email yangweili@zju.edu.cn
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 122
Est. completion date December 31, 2029
Est. primary completion date December 31, 2029
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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

Study Design


Intervention

Drug:
Imatinib
Imatinib neoadjuvant therapy

Locations

Country Name City State
China The First Affiliated Hospital, College of Medicine, Zhejiang University Hangzhou Zhejiang

Sponsors (7)

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

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Progression free survival(PFS) Progression free survival(PFS) 5 years
Secondary Overall survival(OS) Overall survival(OS) 5 years
Secondary Objective Response Rate (ORR) Rate of complete and partial response according to Choi criteria Up to 1 year
Secondary R0 resection rate complete resection rate with microscopically negative margin Up to 1 year
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