Advanced LeiomyosarcomaLMS-HOPENCT07405346

A Trial for Advanced Leiomyosarcoma With Human Organoid-guided Personalized Efficacy

A study testing treatment based on the results of drug sensitivity analysis in people with Advanced Leiomyosarcoma, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts

Official record

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Trial 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). Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Advanced Leiomyosarcoma
What is being tested?: treatment based on the results of drug sensitivity analysis
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 50 participants
Where: 1 siteChina
Study dates: 1 Mar 2026to 30 Dec 2027
Phase: Interventional
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Age ≥ 18 years old and ≤ 75 years old, gender not limited;
Patients pathologically confirmed leiomyosarcoma, who have not received systemic treatment in the advanced stage;
According to the RECIST 1.1 standard, there are measurable target lesions present;
The metastatic or primary lesion can obtain sufficient biopsy tissue;
Eastern Cooperative Oncology Group (ECOG) performance status score ranges from 0 to 1, and for amputees, it can be relaxed to 2 points;
Expected survival period ≥ 6 months;

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Good bone marrow reserve function: HB ≥ 90g/L; ANC≥1.5×109/L；PLT≥80×109/L；
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;
Good coagulation function: International normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 times ULN, activated partial thromboplastin time (APTT) ≤ 1.5 times ULN;
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.
The patient voluntarily joined this study and signed an informed consent form (ICF), with good compliance and cooperation with follow-up.

Who cannot join

Patients with peripheral nervous system disorders caused by diseases or those with a history of significant mental and central nervous system disorders;
Patients with severe infections or active digestive ulcers requiring treatment;
Those who are allergic to relevant therapeutic drugs or have surgical contraindications;
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;
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.
Severe liver disease (such as cirrhosis), kidney disease, respiratory disease, blood system disease or uncontrollable diabetes;

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There are patients infected with hepatitis B, hepatitis C, syphilis and AIDS;
Patients who relapse within 6 months after adjuvant chemotherapy;
During the adjuvant therapy period, the cumulative equivalent dose of doxorubicin is greater than 120mg/m2;
Patients who are currently participating or have participated in other clinical trials within the past month;
Patients deemed unsuitable for inclusion by researchers.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

China1 site

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430000

Other trials in China

About this study

Official title: Clinical Study on First-line Treatment for Advanced Leiomyosarcoma Based on Drug Sensitivity of Organoid

Read the detailed description

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.

Conditions: Advanced Leiomyosarcoma
Being tested: treatment based on the results of drug sensitivity analysis
Keywords: Advanced Leiomyosarcoma, organoid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

treatment based on the results of drug sensitivity analysisDrug
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.

Study groups in NCT07405346
Study group	Role	What they receive
Treatment group relying on organoid drug sensitivity results	Experimental	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. Receives: Drug: treatment based on the results of drug sensitivity analysis

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: from the first drug administration up to two years

Secondary outcomes (2)

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.
Measured: 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.
Measured: from the first drug administration up to six month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Mar 202630 Dec 2027

First posted12 Feb 2026
Study start1 Mar 2026 (estimated)
Primary completion30 Jun 2027 (estimated)
Study completion30 Dec 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Advanced LeiomyosarcomaStudies of the same condition, open and under way.
More trials run by Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 50 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07405346
Sponsor's protocol ID: LMS-HOPE
Acronym: LMS-HOPE
Status last verified: Oct 2025
First submitted: 5 Feb 2026
Last updated: 12 Feb 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Interested in taking part?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

RecruitingPhase 1
Testing Low-Dose Common Chemotherapy (Liposomal Doxorubicin) in Combination With an Anti-Cancer Drug, Peposertib, in Advanced Sarcoma
Metastatic Dedifferentiated Liposarcoma, Metastatic Leiomyosarcoma
Active, not recruitingPhase 1
A Phase I Trial of Combination Gemcitabine and Nab-Sirolimus in Advanced Leiomyosarcomas or Advanced Soft-Tissue Sarcomas With TSC2 or TSC1 Loss-of-function Mutations or Deletions
Leiomyosarcoma, Soft-tissue Sarcomas
RecruitingPhase 2
A Study of Ivonescimab in People With Leiomyosarcoma
Leiomyosarcoma
RecruitingPhase 1/2
STC-15 as a Part of Combination Therapy With Toripalimab in Selected Advanced Cancers and as Monotherapy in Participants With Selected Sarcomas
Solid Tumor, Sarcoma
RecruitingPhase 1/2
Testing the Addition of an Anti-cancer Drug, Abemaciclib, to the Usual Chemotherapy Treatment (Gemcitabine) for Soft Tissue Sarcoma
Advanced Dedifferentiated Liposarcoma, Advanced Leiomyosarcoma

All Advanced Leiomyosarcoma trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Study on First-line Treatment for Advanced Leiomyosarcoma Based on Drug Sensitivity of Organoid
ClinicalTrials.gov ID: NCT07405346
Acronym / sponsor ID: LMS-HOPE / LMS-HOPE
Conditions: Advanced Leiomyosarcoma
Keywords: Advanced Leiomyosarcoma, organoid
Study type: Interventional
Recruitment status: Enrolling by invitation
Enrolment: 50 participants (estimated)
Lead sponsor: Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyUniversity, hospital or other
Collaborators: Fudan University, Zhejiang Cancer Hospital, West China Hospital, Xiangya Hospital of Central South University, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, Peking University Cancer Hospital & Institute, Cancer Institute and Hospital, Chinese Academy of Medical Sciences, First Affiliated Hospital of Guangxi Medical University, Hubei Cancer Hospital, Henan Cancer Hospital, Second Xiangya Hospital of Central South University, Tianjin Hospital, First Affiliated Hospital of Fujian Medical University
Study start: 1 Mar 2026 (estimated)
Primary completion: 30 Jun 2027 (estimated)
Study completion: 30 Dec 2027 (estimated)
First posted: 12 Feb 2026 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Treatment group relying on organoid drug sensitivity results	Experimental	Drug: treatment based on the results of drug sensitivity analysisDuring 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.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

Age ≥ 18 years old and ≤ 75 years old, gender not limited;
Patients pathologically confirmed leiomyosarcoma, who have not received systemic treatment in the advanced stage;
According to the RECIST 1.1 standard, there are measurable target lesions present;
The metastatic or primary lesion can obtain sufficient biopsy tissue;
Eastern Cooperative Oncology Group (ECOG) performance status score ranges from 0 to 1, and for amputees, it can be relaxed to 2 points;

Key exclusion criteria (11 listed)

Patients with peripheral nervous system disorders caused by diseases or those with a history of significant mental and central nervous system disorders;
Patients with severe infections or active digestive ulcers requiring treatment;
Those who are allergic to relevant therapeutic drugs or have surgical contraindications;
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;
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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
treatment based on the results of drug sensitivity analysisDuring 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.	Drug	Treatment group relying on organoid drug sensitivity results

Primary outcome

objective response rate (ORR)
Time frame: from the first drug administration up to two years
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.

2 secondary outcomes

Progression-free survival (PFS)
Time frame: from the first drug administration up to two years
6-month PFS rate
Time frame: from the first drug administration up to six month

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2026.
Individual participant dataSharing planned: No

Related trials for Advanced Leiomyosarcoma

RecruitingPhase 1
Testing Low-Dose Common Chemotherapy (Liposomal Doxorubicin) in Combination With an Anti-Cancer Drug, Peposertib, in Advanced Sarcoma
Metastatic Dedifferentiated Liposarcoma, Metastatic Leiomyosarcoma
Active, not recruitingPhase 1
A Phase I Trial of Combination Gemcitabine and Nab-Sirolimus in Advanced Leiomyosarcomas or Advanced Soft-Tissue Sarcomas With TSC2 or TSC1 Loss-of-function Mutations or Deletions
Leiomyosarcoma, Soft-tissue Sarcomas
RecruitingPhase 2
A Study of Ivonescimab in People With Leiomyosarcoma
Leiomyosarcoma
RecruitingPhase 1/2
STC-15 as a Part of Combination Therapy With Toripalimab in Selected Advanced Cancers and as Monotherapy in Participants With Selected Sarcomas
Solid Tumor, Sarcoma
RecruitingPhase 1/2
Testing the Addition of an Anti-cancer Drug, Abemaciclib, to the Usual Chemotherapy Treatment (Gemcitabine) for Soft Tissue Sarcoma
Advanced Dedifferentiated Liposarcoma, Advanced Leiomyosarcoma

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 12 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

objective response rate (ORR) (time frame: from the first drug administration up to two years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07405346.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2026.