This study is a prospective single arm multicenter intervention study aimed at evaluating the feasibility of using organoid drug sensitivity results to guide first-line treatment of advanced leiomyosarcoma. The primary endpoint of the study is objective response rate (ORR). The secondary endpoint are Progression Free Survival (PFS) and 6-month PFS rate.
In this study, fresh tissues of the patient's primary lesion and/or metastatic lesion were obtained for constructing a tumor organoid model. Perform drug sensitivity analysis on the constructed organoids. During the waiting period for organoid culture and drug sensitivity analysis results (approximately 3-4 weeks), all patients received one cycle of standard AI regimen chemotherapy (doxorubicin at least 50 mg/m ²+ifosfamide at least 6000 mg/m ²). Based on the results of drug sensitivity analysis and the patient's clinical response, comprehensively evaluate and adjust the treatment plan. By observing the clinical improvement status of patients, evaluate the accuracy and effectiveness of predicting drug efficacy based on organoid drug sensitivity results.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
During the waiting period for organoid culture and drug sensitivity analysis results (approximately 3-4 weeks), all patients received one cycle of standard AI regimen chemotherapy (doxorubicin at least 50 mg/m ²+ifosfamide at least 6000 mg/m ²). Based on the results of drug sensitivity analysis and the patient's clinical response, comprehensively evaluate and adjust the treatment plan.
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
objective response rate (ORR)
ORR is the proportion of patients with best response of complete response (CR) and partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and iRECIST.
Time frame: from the first drug administration up to two years
Progression-free survival (PFS)
Time from the date of first study treatment administration to the date of first documented tumor progression or death due to any cause, whichever occurs first.
Time frame: from the first drug administration up to two years
6-month PFS rate
The proportion of patients who are still in a progression free survival state from the first systemic treatment to the total number of patients in this study.
Time frame: from the first drug administration up to six month
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