Actively Recruiting
Prospective Multicenter Clinical Study of Neoadjuvant Imatinib Mesylate for Gastrointestinal Stromal Tumors
Led by First Affiliated Hospital of Zhejiang University · Updated on 2021-10-12
122
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
F
First Affiliated Hospital of Zhejiang University
Lead Sponsor
S
Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying gastrointestinal stromal tumors (GIST) with a high risk of recurrence to see if neoadjuvant treatment with imatinib mesylate improves long-term outcomes. This phase 2 study focuses on whether using imatinib before surgery can increase the rate of complete tumor removal and improve 5-year progression-free survival for patients with high-risk GIST. Previous studies suggest imatinib might help, but its impact on long-term survival is still unclear. Participants will take oral imatinib mesylate at a dose of 400 mg once daily for 3 to 12 months, as long as their disease does not progress or side effects are unacceptable. After this preoperative treatment, those with stable or responding disease will have surgery to remove the tumor within one week. Following complete surgery, patients will continue taking oral imatinib mesylate 400 mg daily for 36 months if tolerated, and they will be followed for a total of five years. Throughout the study, patients will be monitored for progression-free survival over five years as the main outcome. Additional measures include overall survival, objective response rate up to one year, and the rate of complete tumor removal. Participants will undergo regular assessments to evaluate treatment response and safety. The study aims to provide detailed data on the long-term benefits and risks of neoadjuvant imatinib in high-risk GIST patients.
CONDITIONS
Brief Title
Prospective Multicenter Clinical Study of Neoadjuvant Imatinib Mesylate for Gastrointestinal Stromal Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 defined by modified NIH 2008: stomach tumor diameter > 10.0cm, nonstomach tumor diameter > 5.0cm
- Age between 18 and 80 years
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Informed consent signed
You will not qualify if you...
- Asp842Val (D842V) mutation in Exon 18 of PDGFRA gene, wild type for c-kit exons 9,11,13,17 and PDGFRA exons 12,18, or c-kit exon 9 mutation
- Prior treatment with tyrosine kinase inhibitors including imatinib
- Elevated liver enzymes (AST and/or ALT > 2.5 x ULN), total bilirubin > 1.5 x ULN, or creatinine > 1.0 x ULN
- Low blood counts: absolute neutrophil count < 1.5 x 10^9/L, platelet count < 75 x 10^9/L, or hemoglobin < 90 g/L
- Presence of other active malignant tumors except basal cell carcinoma or treated cervical cancer in situ
- Distant metastases present
- Serious cardiovascular or cerebrovascular events within 12 months prior to study
- Positive HIV antibody test
- Participation in other clinical trials
- Pregnant or lactating women or those with fertility not using contraception
- Other serious acute or chronic physical or mental conditions increasing risk or interfering with study participation as judged by researchers
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 3 to 12 months
Participants receive oral imatinib mesylate 400mg once daily for 3 to 12 months in the absence of disease progression or unacceptable toxicity before surgery.
Regular visits during treatment period
Duration - 1 week
Within 1 week after completion of preoperative imatinib, participants with responding or stable disease undergo surgical resection.
1 surgical visit
Duration - 36 months
After complete resection, participants receive oral imatinib mesylate 400mg once daily for 36 months in the absence of disease progression or unacceptable toxicity.
Regular visits during treatment period
Duration - 5 years
Participants are followed for 5 years after treatment to monitor progression free survival and overall survival.
Periodic follow-up visits
Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital, College of Medicine, Zhejiang University
Hangzhou, Zhejiang, China, 310003
Actively Recruiting
Research Team
W
Weili Yang, Doctor
J
Jiren Yu
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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