By InvitationNot Applicable

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

China30 participantsStarted 2026-04-01

Plain-language 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).

Who can participate

Age range1 Year – 18 Years

SexALL

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Inclusion criteria

✓. 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.

Exclusion criteria

✕. 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.

What they're measuring

objective response rate (ORR)

Timeframe: from the first drug administration up to two years

Trial details

NCT IDNCT07528079

SponsorShanghai Jiao Tong University School of Medicine

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-08-30

View on ClinicalTrials.gov More Soft Tissue Sarcoma, Child trials