Organoid-based Sensitivity-guided Chemotherapy for Advanced / Refractory Pediatric Tumors
Enrolling by invitation · Not applicable
Conditions studied: Soft Tissue Sarcoma, Child
In brief
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).
Key facts
- Study ID
- NCT07528079
- Run by
- Shanghai Jiao Tong University School of Medicine
- People needed
- 30
- Starts
- 2026-04-01
- Expected to finish
- 2027-12-30
- Last updated by the study team
- 2026-04-16
Who can join
Age: 1 and older, up to 18. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age between 1 and 18 years, gender unrestricted.
- Patients with histopathologically confirmed rhabdomyosarcoma, Ewing sarcoma, malignant rhabdoid tumor, or non-rhabdomyosarcoma soft tissue sarcoma.
- Previous receipt of at least one line of systemic anti-tumor therapy with subsequent disease progression.
- Presence of measurable target lesions according to RECIST 1.1 criteria.
- Sufficient biopsy tissue can be obtained from either metastatic or primary lesions.
- ECOG performance status score of 0 to 1.
- Expected overall survival ≥ 6 months.
- Adequate bone marrow reserve: HB ≥ 90 g/L; ANC ≥ 1.5×10⁹/L; PLT ≥ 80×10⁹/L.
- Adequate hepatic and renal function: total bilirubin ≤ 1.5 × upper limit of normal (ULN); ALT and AST ≤ 2.5 × ULN; serum creatinine ≤ ULN.
- Voluntary participation in the study with signed written informed consent form (ICF), good compliance, and willingness to comply with follow-up procedures.
You may not qualify if…
- Patients with peripheral nervous system disorders caused by the disease, or a history of significant psychiatric or central nervous system disorders.
- Patients with severe infection or active peptic ulcer requiring treatment.
- Patients currently participating in other clinical trials or who have participated within the past 3 weeks.
- Patients deemed ineligible by the investigator for any other reason.
Where it is running
- Shanghai Children's Medical Center Affiliated to Shanghai Jiao Tong University School of Medicine — Shanghai, Shanghai Municipality, China
Full record on ClinicalTrials.gov
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