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

Primary Purpose

Progression-free Survival, Gastrointestinal Stromal Tumor, Neoadjuvant

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Imatinib
Sponsored by
First Affiliated Hospital of Zhejiang University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Progression-free Survival focused on measuring Progression-free survival, Gastrointestinal Stromal Tumors, neoadjuvant

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The First Affiliated Hospital, College of Medicine, Zhejiang UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Imatinib neoadjuvant

Arm Description

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.

Outcomes

Primary Outcome Measures

Progression free survival（PFS）
Progression free survival（PFS）

Secondary Outcome Measures

Overall survival（OS）
Overall survival（OS）
Objective Response Rate （ORR）
Rate of complete and partial response according to Choi criteria
R0 resection rate
complete resection rate with microscopically negative margin

Full Information

First Posted
June 9, 2021
Last Updated
October 9, 2021
Sponsor
First Affiliated Hospital of Zhejiang University
Collaborators
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 affiliated to Wenzhou Medical University, Ningbo No. 1 Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04933669
Brief Title
Prospective Multicenter Clinical Study of Neoadjuvant Imatinib Mesylate for Gastrointestinal Stromal Tumors
Acronym
ZJGIST-01
Official Title
Prospective Multicenter Clinical Study of Neoadjuvant Imatinib Mesylate for Gastrointestinal Stromal Tumors
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Recruiting
Study Start Date
September 7, 2021 (Actual)
Primary Completion Date
December 31, 2029 (Anticipated)
Study Completion Date
December 31, 2029 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
First Affiliated Hospital of Zhejiang University
Collaborators
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 affiliated to Wenzhou Medical University, Ningbo No. 1 Hospital

4. Oversight

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
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Progression-free Survival, Gastrointestinal Stromal Tumor, Neoadjuvant
Keywords
Progression-free survival, Gastrointestinal Stromal Tumors, neoadjuvant

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
122 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Imatinib neoadjuvant
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Imatinib
Other Intervention Name(s)
neoadjuvant therapy
Intervention Description
Imatinib neoadjuvant therapy
Primary Outcome Measure Information:
Title
Progression free survival（PFS）
Description
Progression free survival（PFS）
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Overall survival（OS）
Description
Overall survival（OS）
Time Frame
5 years
Title
Objective Response Rate （ORR）
Description
Rate of complete and partial response according to Choi criteria
Time Frame
Up to 1 year
Title
R0 resection rate
Description
complete resection rate with microscopically negative margin
Time Frame
Up to 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Weili Yang, Doctor
Phone
+8613989879196
Email
yangweili@zju.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Jiren Yu
Phone
+8657187236147
Email
yujr0909@zju.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jiren Yu
Organizational Affiliation
Zhejiang University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The First Affiliated Hospital, College of Medicine, Zhejiang University
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310003
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jiren Yu

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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