beta
Trial Radar AI
Clinical Trial NCT04933669 (ZJGIST-01) for Progression-free Survival, Gastrointestinal Stromal Tumor, Neoadjuvant is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
One study matched filter criteria
Card View
Back to Search

Prospective Multicenter Clinical Study of Neoadjuvant Imatinib Mesylate for Gastrointestinal Stromal Tumors (ZJGIST-01) Phase 2 122

Recruiting
Clinical Trial NCT04933669 (ZJGIST-01) is designed to study Treatment for Progression-free Survival, Gastrointestinal Stromal Tumor, Neoadjuvant. It is a Phase 2 interventional study that is recruiting, having started on September 7, 2021, with plans to enroll 122 participants. Led by First Affiliated Hospital of Zhejiang University, it is expected to complete by December 31, 2029. The latest data from ClinicalTrials.gov was last updated on October 12, 2021.
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 r...Show More
Official Title

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

Conditions
Progression-free SurvivalGastrointestinal Stromal TumorNeoadjuvant
Other Study IDs
  • ZJGIST-01
  • IIT20210023C-R1
NCT ID Number
NCT04933669
Start Date (Actual)
2021-09-07
Last Update Posted
2021-10-12
Completion Date (Estimated)
2029-12-31
Enrollment (Estimated)
122
Study Type
Interventional
PHASE
Phase 2
Status
Recruiting
Keywords
Progression-free survival
Gastrointestinal Stromal Tumors
neoadjuvant
Primary Purpose
Treatment
Design Allocation
N/A
Interventional Model
Single Group
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalImatinib 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 unaccept...Show More
Imatinib
Imatinib neoadjuvant therapy
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Progression free survival（PFS）
Progression free survival（PFS）
5 years
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Overall survival（OS）
Overall survival（OS）
5 years
Objective Response Rate （ORR）
Rate of complete and partial response according to Choi criteria
Up to 1 year
R0 resection rate
complete resection rate with microscopically negative margin
Up to 1 year
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
  • 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

  • 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
First Affiliated Hospital of Zhejiang University logoFirst Affiliated Hospital of Zhejiang University
Study Responsible Party
Yu jiren, Principal Investigator, Chief of Gastrointestinal Surgery, First Affiliated Hospital of Zhejiang University
Study Central Contact
Contact: Weili Yang, Doctor, +8613989879196, [email protected]
Contact: Jiren Yu, +8657187236147, [email protected]
1 Study Locations in 1 Countries

Zhejiang

The First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, Zhejiang, 310003, China
Jiren Yu, Contact
Recruiting