Clinical trial NCT04933669: Prospective Multicenter Clinical Study of Neoadjuvant Imatinib Mesylate for Gastrointestinal Stromal Tumors
Official title: Prospective Multicenter Clinical Study of Neoadjuvant Imatinib Mesylate for Gastrointestinal Stromal Tumors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Progression-free Survival
Gastrointestinal Stromal Tumor
Neoadjuvant
Keywords: Progression-free survival
Gastrointestinal Stromal Tumors
neoadjuvant
Lead sponsor: First Affiliated Hospital of Zhejiang University
Sponsor class: OTHER
Collaborators: name: Second Affiliated Hospital, School of Medicine, Zhejiang University
name: Sir Run Run Shaw Hospital
name: Zhejiang Cancer Hospital
name: First Affiliated Hospital of Wenzhou Medical University
name: Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University
name: Ningbo No. 1 Hospital
First posted: 2021-06-22
Enrollment: 122
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Progression free survival（PFS）
timeFrame: 5 years
Secondary outcomes:
measure: Overall survival（OS）
timeFrame: 5 years
measure: Objective Response Rate （ORR）
timeFrame: Up to 1 year
measure: R0 resection rate
timeFrame: Up to 1 year
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: The First Affiliated Hospital, College of Medicine, Zhejiang University
state: Zhejiang
Study officials:
affiliation: Zhejiang University
name: Jiren Yu
role: PRINCIPAL_INVESTIGATOR
References: