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

NCT07405346 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2026-02-12

No results posted yet for this study

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.

Conditions

  • Advanced Leiomyosarcoma

Interventions

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.

Sponsors & Collaborators

  • Fudan University

    collaborator OTHER

  • Zhejiang Cancer Hospital

    collaborator OTHER

  • West China Hospital

    collaborator OTHER

  • Xiangya Hospital of Central South University

    collaborator OTHER

  • The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

    collaborator OTHER

  • Peking University Cancer Hospital & Institute

    collaborator OTHER

  • Cancer Institute and Hospital, Chinese Academy of Medical Sciences

    collaborator OTHER

  • First Affiliated Hospital of Guangxi Medical University

    collaborator OTHER

  • Hubei Cancer Hospital

    collaborator OTHER

  • Henan Cancer Hospital

    collaborator OTHER_GOV

  • Second Xiangya Hospital of Central South University

    collaborator OTHER

  • Tianjin Hospital

    collaborator OTHER

  • First Affiliated Hospital of Fujian Medical University

    collaborator OTHER

  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-01
Primary Completion
2027-06-30
Completion
2027-12-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07405346 on ClinicalTrials.gov