Tumor avatars could personalize sarcoma therapy
NCT ID NCT07405346
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study aims to see if growing a patient's tumor cells in the lab (called organoids) can help doctors choose the most effective first-line chemotherapy for advanced leiomyosarcoma, a rare cancer of smooth muscle. About 50 adults aged 18-75 who have not yet received systemic treatment will be enrolled. The main goal is to improve the tumor shrinkage rate and delay cancer progression.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 50 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Mar 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Age ≥ 18 years old and ≤ 75 years old, gender not limited;\<p\> 2. Patients pathologically confirmed leiomyosarcoma, who have not received systemic treatment in the advanced stage;\<p\> 3. According to the RECIST 1.1 standard, there are measurable target lesions present;\<p\> 4. The metastatic or primary lesion can obtain sufficient biopsy tissue;\<p\> 5. Eastern Cooperative Oncology Group (ECOG) performance status score ranges from 0 to 1, and for amputees, it can be relaxed to 2 points;\<p\> 6. Expected survival period ≥ 6 months;\<p\> 7. Good bone marrow reserve function: HB ≥ 90g/L; ANC≥1.5×109/L;PLT≥80×109/L;\<p\> 8. 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\> 9. Good coagulation function: International normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 times ULN, activated partial thromboplastin time (APTT) ≤ 1.5 times ULN;\<p\> 10. Female subjects with fertility must undergo a serum pregnancy test within 3 days before the first medication and the result must be negative. If a female subject with fertility has sexual intercourse with an unsterilized male partner, the subject must self screen and adopt an acceptable contraceptive method, and must agree to continue using the contraceptive method for 6 months after the last administration of the study drug; Whether to stop contraception after this point in time should be discussed with the researchers.\<p\> 11. The patient voluntarily joined this study and signed an informed consent form (ICF), with good compliance and cooperation with follow-up. Exclusion Criteria: 1. Patients with peripheral nervous system disorders caused by diseases or those with a history of significant mental and central nervous system disorders;\<p\> 2. Patients with severe infections or active digestive ulcers requiring treatment;\<p\> 3. Those who are allergic to relevant therapeutic drugs or have surgical contraindications;\<p\> 4. 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\> 5. 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\> 6. Severe liver disease (such as cirrhosis), kidney disease, respiratory disease, blood system disease or uncontrollable diabetes;\<p\> 7. There are patients infected with hepatitis B, hepatitis C, syphilis and AIDS;\<p\> 8. Patients who relapse within 6 months after adjuvant chemotherapy;\<p\> 9. During the adjuvant therapy period, the cumulative equivalent dose of doxorubicin is greater than 120mg/m2;\<p\> 10. Patients who are currently participating or have participated in other clinical trials within the past month;\<p\> 11. Patients deemed unsuitable for inclusion by researchers.
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Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430000, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.