NCT07528079Enrolling by invitation
Organoid-based Sensitivity-guided Chemotherapy for Advanced / Refractory Pediatric Tumors
A Clinical Study on Organoid-Based Drug Sensitivity-Guided Chemotherapy for High-Risk, Relapsed, and Refractory Pediatric Soft Tissue Malignant Tumors
Source: ClinicalTrials.gov · Last updated 16 Apr 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Enrolling by invitation
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 7 Apr 2026
- Start date
- 1 Apr 2026
- Primary completion date
- 30 Aug 2027
- Lead sponsor
- Shanghai Jiao Tong University School of Medicine
- Diseases
- Childhood cancers, Sarcoma
- NCT number
- NCT07528079
What you commit to
- Study type: Interventional
- Planned participants: 30
- From 1 Apr 2026 to the primary completion date, 30 Aug 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 1 year to 18 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Shanghai Children's Medical Center Affiliated to Shanghai Jiao Tong University School of Medicine Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.