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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.

Key facts

Who runs it
Shanghai Jiao Tong University School of Medicine
Where
Shanghai, ChinaSee the site
Trial code
Registry title
Organoid-based Sensitivity-guided Chemotherapy for Advanced / Refractory Pediatric Tumors
Status
Enrolling by invitation
People taking part
30 people, planned
Started
1 Apr 2026
Expected to end
30 Dec 2027
Type of study
Interventional
Treatments tested
  • treatment based on the results of drug sensitivity analysis
Record updated
16 April 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for children and teenagers aged 1 to 18 with certain soft tissue cancers that came back or got worse after earlier treatment. Chemotherapy is chosen using drug tests on lab-grown tumor samples.

Age
1 to 18 years
Sex
All sexes can join.
Disease stage
Confirmed rhabdomyosarcoma, Ewing sarcoma, malignant rhabdoid tumor, or other soft tissue sarcoma. The disease must have progressed. Measurable tumor lesions (RECIST 1.1) are needed.
Earlier treatment
At least one earlier line of whole-body anti-tumor treatment, followed by disease progression. Cannot have been in another clinical trial within the past 3 weeks.

Main reasons for not taking part

  • Nerve disorders caused by the disease, or a history of significant psychiatric or central nervous system disorders
  • Severe infection or active stomach ulcer that needs treatment
  • Currently in another clinical trial, or in one within the past 3 weeks
  • Not enough tumor tissue obtainable by biopsy
  • Blood counts, liver or kidney tests outside the limits set in the record

The registry criteria, word for word

Show all 14 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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

Check if you might fit

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?

Where in China

  • Shanghai Children's Medical Center Affiliated to Shanghai Jiao Tong University School of MedicineShanghai, ChinaNo longer taking part

About the trial

What the trial wants to find out

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).

The group in the trial

  • Treatment group relying on organoid drug sensitivity resultsTreatment being tested

    Treatment regimens will be comprehensively evaluated and adjusted based on the results of patient-derived organoid drug sensitivity testing in combination with clinical response.

    Treatment: treatment based on the results of drug sensitivity analysis

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
A Clinical Study on Organoid-Based Drug Sensitivity-Guided Chemotherapy for High-Risk, Relapsed, and Refractory Pediatric Soft Tissue Malignant Tumors
Plain-language title
Lab-grown tumor models to guide chemotherapy in children with hard-to-treat soft tissue cancersGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT07528079, who can take part
Record updated
16 April 2026