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 range
1 Year – 18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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
. 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.