Lab-grown tumor models to guide chemotherapy in children with hard-to-treat soft tissue cancers
Tests chemotherapy chosen by lab-grown tumor models in children with relapsed soft tissue sarcoma.
Plain-language title generated from the registry record
Registry title: Organoid-based Sensitivity-guided Chemotherapy for Advanced / Refractory Pediatric Tumors
Key facts
- Where
- Shanghai, ChinaSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 1 and 18 years old?
Source: NCT07528079, who can take part
Where in China
- Shanghai Children's Medical Center Affiliated to Shanghai Jiao Tong University School of MedicineShanghai, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Shanghai Jiao Tong University School of Medicine
- Trial code
- NCT07528079
- Record updated
- 16 April 2026
- Original description
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).Read full original descriptionShow less
A Clinical Study on Organoid-Based Drug Sensitivity-Guided Chemotherapy for High-Risk, Relapsed, and Refractory Pediatric Soft Tissue Malignant Tumors
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).
Inclusion: 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.
Exclusion: 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.