Organoid-based Sensitivity-guided Chemotherapy for Advanced / Refractory Pediatric Tumors

NCT07528079 · tracked via the Priya Life Science China tracker

Sponsor

Shanghai Jiao Tong University School of Medicine

Phase

Not applicable

Started

2026-04-01

Last updated

2026-04-16

Condition(s) studied

Soft Tissue Sarcoma, Child

Investigational drug(s) / intervention(s)

treatment based on the results of drug sensitivity analysis

treatment based on the results of drug sensitivity analysis: Treatment regimens will be comprehensively evaluated and adjusted based on the results of patient-derived organoid drug sensitivity testing in combination with clinical response.

Study summary

This is a prospective, open-label, single-arm, single-center study designed to evaluate the feasibility of using patient-derived organoid drug sensitivity analysis to guide chemotherapy for pediatric patients with refractory and relapsed malignant soft tissue tumors. The primary endpoint of the study is objective response rate (ORR), and the secondary endpoint is event-free survival (EFS).

Eligibility

Sex

ALL

Min age

1 Year

Max age

18 Years

Healthy volunteers

Inclusion Criteria: 1. Age between 1 and 18 years, gender unrestricted. 2. Patients with histopathologically confirmed rhabdomyosarcoma, Ewing sarcoma, malignant rhabdoid tumor, or non-rhabdomyosarcoma soft tissue sarcoma. 3. Previous receipt of at least one line of systemic anti-tumor therapy with subsequent disease progression. 4. Presence of measurable target lesions according to RECIST 1.1 criteria. 5. Sufficient biopsy tissue can be obtained from either metastatic or primary lesions. 6. ECOG performance status score of 0 to 1. 7. Expected overall survival ≥ 6 months. 8. Adequate bone marrow reserve: HB ≥ 90 g/L; ANC ≥ 1.5×10⁹/L; PLT ≥ 80×10⁹/L. 9. Adequate hepatic and renal function: total bilirubin ≤ 1.5 × upper limit of normal (ULN); ALT and AST ≤ 2.5 × ULN; serum creatinine ≤ ULN. 10. Voluntary participation in the study with signed written informed consent form (ICF), good compliance, and willingness to comply with follow-up procedures. Exclusion Criteria: 1. Patients with peripheral nervous system disorders caused by the disease, or a history of significant psychiatric or central nervous system disorders. 2. Patients with severe infection or active peptic ulcer requiring treatment. 3. Patients currently participating in other clinical trials or who have participated within the past 3 weeks. 4. Patients deemed ineligible by the investigator for any other reason.

Primary outcome measure(s)

objective response rate (ORR) — 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.

Trial sites (1)

Facility	City	Region	Status
Shanghai Children's Medical Center Affiliated to Shanghai Jiao Tong University School of Medicine	Shanghai	Shanghai Municipality

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07528079 on ClinicalTrials.gov ↗ ← All trials in China