Gastrointestinal Stromal Tumor Clinical Trial
— ZJGIST-01Official title:
Prospective Multicenter Clinical Study of Neoadjuvant Imatinib Mesylate for Gastrointestinal Stromal Tumors
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.
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 |
Country | Name | City | State |
---|---|---|---|
China | The First Affiliated Hospital, College of Medicine, Zhejiang University | Hangzhou | Zhejiang |
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 |
China,
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01769248 -
Prospective Trial of EUS-FNA Versus EUS-FNB Using a Novel Core Biopsy Needle
|
N/A | |
Completed |
NCT01774162 -
EUS-guided Fine Needle Biopsy With a New Core Histology Needle Versus Conventional Fine Needle Aspiration
|
N/A | |
Completed |
NCT01110668 -
Evaluation of Nilotinib In Patients With Advanced Gastrointestinal Stromal Tumor (GIST)
|
Phase 2 | |
Terminated |
NCT00091078 -
Oblimersen and Imatinib Mesylate in Treating Patients With Advanced Gastrointestinal Stromal Tumors That Cannot Be Removed By Surgery
|
Phase 2 | |
Completed |
NCT00025246 -
Imatinib Mesylate in Treating Patients With Gastrointestinal Stromal Tumor That Has Been Completely Removed During Surgery
|
Phase 2 | |
Active, not recruiting |
NCT00265798 -
Sorafenib in Treating Patients With Malignant Gastrointestinal Stromal Tumor That Progressed During or After Previous Treatment With Imatinib Mesylate and Sunitinib Malate
|
Phase 2 | |
Recruiting |
NCT04143048 -
A Study on Non-invasive Early Diagnosis of Gastrointestinal Stromal Tumors and Differentiation of Benign and Malignant Nodules
|
||
Recruiting |
NCT02931981 -
Serum Dickkopf-4 as a Biomarker for the Diagnosis and Treatment of Gastrointestinal Stromal Tumor
|
N/A | |
Not yet recruiting |
NCT02576080 -
Efficacy of Imatinib in Patients With Intermediate-risk Gastrointestinal Stromal Tumor With a High-risk Genomic Grade Index
|
Phase 3 | |
Recruiting |
NCT01389583 -
A Study of AUY922 for GIST(Gastrointestinal Stromal Tumor) Patients
|
Phase 2 | |
Recruiting |
NCT00777504 -
Study to the Optimal Duration of Therapy With Oral Angiogenesis Inhibitors
|
Phase 4 | |
Completed |
NCT00764595 -
Imatinib Mesylate in Treating Patients With Liver Metastasis From a Gastrointestinal Stromal Tumor
|
Phase 2 | |
Completed |
NCT00769782 -
Surgery in Treating Patients With Liver Metastasis From a Gastrointestinal Stromal Tumor
|
Phase 2 | |
Completed |
NCT00098579 -
Doxorubicin Hydrochloride and Alvocidib in Treating Patients With Metastatic or Recurrent Sarcoma That Cannot Be Removed By Surgery
|
Phase 1 | |
Completed |
NCT00005862 -
SU5416 in Treating Patients With Advanced, Metastatic, or Recurrent Soft Tissue Sarcomas
|
Phase 2 | |
Completed |
NCT00004895 -
Octreotide as Palliative Therapy for Cancer-Related Bowel Obstruction That Cannot Be Removed by Surgery
|
Phase 2 | |
Recruiting |
NCT02776878 -
A Clinical Trial Evaluating the Efficacy and Safety of Dasatinib in Refractory Metastatic GIST
|
N/A | |
Completed |
NCT01751919 -
A Clinical Trial to Compare the Pharmacokinetics of Imatinib Mesylate Tablet 400mg (1 Tablet) and Glivec Film-coated Tablet 100mg (4 Tablets)(Phase I)
|
Phase 1 | |
Completed |
NCT01267695 -
Perioperative Imatinib Mesylate in Treating Patients With Locally Advanced Gastrointestinal Stromal Tumor
|
Phase 2 | |
Terminated |
NCT00956072 -
Imatinib Mesylate With or Without Surgery in Treating Patients With Metastatic Gastrointestinal Stromal Tumor That is Responding to Imatinib Mesylate
|
Phase 3 |