Status:
NOT_YET_RECRUITING
Preoperative Imatinib Mesylate Combined With Rectal-sparing Surgery in Patients With c-KIT Gene-mutant Rectal GIST
Lead Sponsor:
Fujian Medical University Union Hospital
Conditions:
Gastrointestinal Stromal Tumor of Rectum
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief Summary
Prior to the implementation of preoperative imatinib mesylate therapy, a considerable percentage (ranging from 34.5% to 67.5%) of individuals diagnosed with rectal gastrointestinal stromal tumors (GIS...
Detailed Description
Prior to the implementation of preoperative imatinib mesylate therapy, a considerable percentage (ranging from 34.5% to 67.5%) of individuals diagnosed with rectal gastrointestinal stromal tumors (GIS...
Eligibility Criteria
Inclusion
- Over the age of 18.
- Newly pathology-diagnosed rectal GIST
- Tumor \> 2cm; local resection of R0 is not possible in the initial evaluation.
- The lower margin of the tumor is ≤ 5cm from the anal verge.
- C-KIT gene mutation.
- Male or non-pregnant female.
- ECOG score 0-2.
- Did not receive targeted therapy before the start of the clinical trial.
- Sufficient organ functions are defined as follows:
- Total bilirubin \< 1.5×ULN (upper limit of normal, ULN), serum AST (SGOT) and ALT (SGPT) \< 2. 5 × ULN, creatinine \< 1.5×ULN, neutrophil count \> 1. 5 ×109 / L, platelet \> 100 × 109 / L.
- The patient's informed consent has been obtained.
Exclusion
- Pathology is non-rectal GIST.
- Under the age of 18.
- Patients with distant metastasis.
- The patient is not permitted to have additional primary malignant tumors within five years unless those tumors are currently deemed clinically insignificant and do not necessitate active intervention, such as basal cell skin cancer or cervical cancer in situ. The presence of any other malignant diseases is strictly prohibited.
- Individuals diagnosed with stage III or IV cardiac conditions, specifically congestive heart failure and myocardial infarction occurring within six months prior to the commencement of the study.
- The patient presents with severe and/or uncontrolled medical ailments, such as unmanaged diabetes, advanced chronic kidney disease, or active uncontrolled infection.
- Co-administration of imatinib with warfarin or acetaminophen is contraindicated, necessitating the substitution of alternative medications (e.g., low molecular weight heparin in place of warfarin).
- Subjects undergoing radiotherapy, chemotherapy, and/or targeted therapy.
- Pregnant or lactating female patients.
- Cognitive or psychiatric disorders.
- Profound cardiac, hepatic, and renal dysfunction.
- Non-adherence by the patient or the researchers' assessment of the patient's inability to complete the entire trial.
Key Trial Info
Start Date :
October 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2029
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT05970900
Start Date
October 1 2023
End Date
October 1 2029
Last Update
August 1 2023
Active Locations (1)
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1
Weizhong Jiang
Fuzhou, Fujian, China, 350001