A Trial for Advanced Leiomyosarcoma With Human Organoid-guided Personalized Efficacy (LMS-HOPE)

February 5, 2026 updated by: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age ≥ 18 years old and ≤ 75 years old, gender not limited;

  2. Patients pathologically confirmed leiomyosarcoma, who have not received systemic treatment in the advanced stage;

  3. According to the RECIST 1.1 standard, there are measurable target lesions present;

  4. The metastatic or primary lesion can obtain sufficient biopsy tissue;

  5. Eastern Cooperative Oncology Group (ECOG) performance status score ranges from 0 to 1, and for amputees, it can be relaxed to 2 points;

  6. Expected survival period ≥ 6 months;

  7. Good bone marrow reserve function: HB ≥ 90g/L; ANC≥1.5×109/L；PLT≥80×109/L；

  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;

  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;

  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.

  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;

  2. Patients with severe infections or active digestive ulcers requiring treatment;

  3. Those who are allergic to relevant therapeutic drugs or have surgical contraindications;

  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;

  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.

  6. Severe liver disease (such as cirrhosis), kidney disease, respiratory disease, blood system disease or uncontrollable diabetes;

  7. There are patients infected with hepatitis B, hepatitis C, syphilis and AIDS;

  8. Patients who relapse within 6 months after adjuvant chemotherapy;

  9. During the adjuvant therapy period, the cumulative equivalent dose of doxorubicin is greater than 120mg/m2;

  10. Patients who are currently participating or have participated in other clinical trials within the past month;

  11. Patients deemed unsuitable for inclusion by researchers.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Treatment group relying on organoid drug sensitivity results

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.
Drug: treatment based on the results of drug sensitivity analysis

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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
from the first drug administration up to two years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Progression-free survival (PFS)
Time Frame: from the first drug administration up to two years
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.
from the first drug administration up to two years
6-month PFS rate
Time Frame: from the first drug administration up to six month
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.
from the first drug administration up to six month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Zhejiang Cancer Hospital
Xiangya Hospital of Central South University
Fudan University
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Henan Cancer Hospital
West China Hospital
Hubei Cancer Hospital
Peking University Cancer Hospital & Institute
First Affiliated Hospital of Fujian Medical University
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Second Xiangya Hospital of Central South University
Tianjin Hospital
First Affiliated Hospital of Guangxi Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 5, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 5, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 12, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 12, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 5, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • LMS-HOPE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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