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NCT05970900

PHASE3

Preoperative Imatinib Mesylate Combined With Rectal-sparing Surgery in Patients With c-KIT Gene-mutant Rectal GIST

Sponsor: Fujian Medical University Union Hospital

View on ClinicalTrials.gov

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 (GIST) underwent abdominoperineal resection (APR), a surgical procedure that involved the removal of the anus and necessitated a permanent colostomy. This study aims to investigate the safety and viability of an organ-preserving approach involving preoperative imatinib mesylate treatment in conjunction with local resection for rectal GIST, specifically targeting patients with c-KIT gene mutations.

Official title: Preoperative Imatinib Mesylate Combined With Rectal-sparing Surgery in Patients With c-KIT Gene-mutant Rectal GIST: an Open-label, Single-arm, Phase III Trial（PIRKER）

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2023-10-01

Completion Date

2029-10-01

Last Updated

2023-08-01

Healthy Volunteers

Conditions

Gastrointestinal Stromal Tumor of Rectum

Interventions

DRUG

Imatinib Mesylate

1. For patients with c-KIT exon 11 mutation, imatinib mesylate, 400mg, qd. 2. For patients with c-KIT exon 9 mutation, imatinib mesylate, 600mg or 800mg, qd.

PROCEDURE

Local resection

According to the characteristics of the location of the tumor, the surgeon decides the surgical approach based on the existing literature and the availability of surgical equipment, including: 1. Local transanal resection (TA) 2. Local resection transsacralapproach 3. Local resection via perineal approach 4. Local resection transvaginal approach

Inclusion Criteria: 1. Over the age of 18. 2. Newly pathology-diagnosed rectal GIST 3. Tumor \> 2cm; local resection of R0 is not possible in the initial evaluation. 4. The lower margin of the tumor is ≤ 5cm from the anal verge. 5. C-KIT gene mutation. 6. Male or non-pregnant female. 7. ECOG score 0-2. 8. Did not receive targeted therapy before the start of the clinical trial. 9. 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. 10. The patient's informed consent has been obtained. Exclusion Criteria: 1. Pathology is non-rectal GIST. 2. Under the age of 18. 3. Patients with distant metastasis. 4. 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. 5. 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. 6. The patient presents with severe and/or uncontrolled medical ailments, such as unmanaged diabetes, advanced chronic kidney disease, or active uncontrolled infection. 7. 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). 8. Subjects undergoing radiotherapy, chemotherapy, and/or targeted therapy. 9. Pregnant or lactating female patients. 10. Cognitive or psychiatric disorders. 11. Profound cardiac, hepatic, and renal dysfunction. 12. Non-adherence by the patient or the researchers' assessment of the patient's inability to complete the entire trial.

Locations (1)

Weizhong Jiang

Fuzhou, Fujian, China