A Trial for Advanced Leiomyosarcoma With Human Organoid-guided Personalized Efficacy (NCT07405346) | Clinical Trial Compass
By InvitationNot Applicable
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 range
18 Years – 75 Years
Sex
ALL
See this in plain English?
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\>
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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
. 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\>
. 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\>