Prospective Multicenter Clinical Study of Neoadjuvant Imatinib Mesylate for Gastrointestinal Stromal Tumors

Gastrointestinal Stromal Tumor Clinical Trial

— ZJGIST-01  

Official title:

Prospective Multicenter Clinical Study of Neoadjuvant Imatinib Mesylate for Gastrointestinal Stromal Tumors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04933669
• Other study ID #: IIT20210023C-R1
• Status: Recruiting
• Phase: Phase 2
• 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
• 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

Related Conditions & MeSH terms

• Disease Progression
• Gastrointestinal Stromal Tumor
• Gastrointestinal Stromal Tumors
• Progression-free Survival

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