A Trial for Advanced Leiomyosarcoma With Human Organoid-guided Personalized Efficacy (NCT07405346) | Clinical Trial Compass
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A Trial for Advanced Leiomyosarcoma With Human Organoid-guided Personalized Efficacy
China50 participantsStarted 2026-03-01
Plain-language summary
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.
Who can participate
Age range18 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Age ≥ 18 years old and ≤ 75 years old, gender not limited;\<p\>
✓. Patients pathologically confirmed leiomyosarcoma, who have not received systemic treatment in the advanced stage;\<p\>
✓. According to the RECIST 1.1 standard, there are measurable target lesions present;\<p\>
✓. The metastatic or primary lesion can obtain sufficient biopsy tissue;\<p\>
✓. Eastern Cooperative Oncology Group (ECOG) performance status score ranges from 0 to 1, and for amputees, it can be relaxed to 2 points;\<p\>
✓. Expected survival period ≥ 6 months;\<p\>
✓. Good bone marrow reserve function: HB ≥ 90g/L; ANC≥1.5×109/L；PLT≥80×109/L；\<p\>
✓. Good liver and kidney function reserve: BILS ≤ 1.5 times the upper limit of normal (ULN); ALT and AST ≤ 2.5 times ULN; Serum creatinine ≤ ULN;\<p\>
Exclusion criteria
✕. Patients with peripheral nervous system disorders caused by diseases or those with a history of significant mental and central nervous system disorders;\<p\>
✕. Patients with severe infections or active digestive ulcers requiring treatment;\<p\>
✕. Those who are allergic to relevant therapeutic drugs or have surgical contraindications;\<p\>
✕
What they're measuring
1
objective response rate (ORR)
Timeframe: from the first drug administration up to two years
Trial details
NCT IDNCT07405346
SponsorUnion Hospital, Tongji Medical College, Huazhong University of Science and Technology
. Patients with other malignant tumors within the past 5 years, except for cured skin basal cell carcinoma, cervical carcinoma in situ, papillary thyroid carcinoma, and other malignant tumors;\<p\>
✕. Those whose heart function meets any of the following criteria: 1) Left ventricular ejection fraction (LVEF)\<50% (detected by echocardiography). 2) The New York Heart Association (NYHA) has a heart function classification of ≥ II. 3) Clinically significant arrhythmias require drug treatment. 4) An acute myocardial infarction occurred within the 6 months prior to enrollment. 5) Uncontrolled hypertension (systolic blood pressure\>160 mmHg or diastolic blood pressure\>100 mmHg). 6) Other heart diseases that have been determined by researchers to be unsuitable for treatment with anthracyclines.\<p\>
✕. Severe liver disease (such as cirrhosis), kidney disease, respiratory disease, blood system disease or uncontrollable diabetes;\<p\>
✕. There are patients infected with hepatitis B, hepatitis C, syphilis and AIDS;\<p\>
✕. Patients who relapse within 6 months after adjuvant chemotherapy;\<p\>