NCT06341998CompletedPhase 2/3
Clinical Study of Chemotherapy in the Treatment of Recurrent/Refractory Yolk Sac Tumor in Children
Clinical Study of Sirolimus Combined With Chemotherapy in the Treatment of Recurrent/Refractory Yolk Sac Tumor in Children
Source: ClinicalTrials.gov · Last updated 19 Sept 2025
Brief summary (registry, in English)
Remarkable progress has been made in treating germ-cell tumor (GCT) through the use of platinum-based regimens. However, part of yolk sac tumor (YST) with cisplatin resistance or recurrence is nevertheless prone to relapse after second-line treatment. This leaves a gap in effective treatment, which needs to be filled by novel therapeutic approaches. This paper is the first one to report the treatment combining sirolimus with nab-paclitaxel, ifosfamide, and carboplatin (S-TIC) for children with repeated relapsed or refractory yolk sac tumor (rrrYST).
- Status (registry)
- Completed
- Phase (registry)
- Phase 2/3
- Study type
- Interventional
- Enrollment
- 32 (actual)
- First submitted
- 26 Mar 2024
- Start date
- 1 Jun 2020
- Primary completion date
- 1 Jan 2024
- Lead sponsor
- Shandong First Medical University
- Diseases
- Childhood cancers
- NCT number
- NCT06341998
What you commit to
- Study type: Interventional · Phase 2/3
- Participants enrolled: 32
- From 1 Jun 2020 to the primary completion date, 1 Jan 2024
- 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.
Prior treatment
- a history of previous tumors
Other illness
- organ failure, specifically involving the heart, brain, liver, or kidneys.
Who the study is looking for
- The pediatric patient is required to present histological confirmation of an extracranial yolk sac tumor.
- At the time of enrollment, the patient must be 18 years of age or younger, with no restrictions based on gender
- The patient must exhibit disease progression following a minimum of two platinum-based chemotherapy regimens or experience a relapse after the completion of treatment
- The patient must have measurable lesions, documented in accordance with the RECIST criteria, or possess an unassessable disease with alpha-fetoprotein (AFP) levels exceeding five times the upper limit of normal
- The Lansky performance status score must be 50 or higher, and the patient's life expectancy should be greater than 12 weeks
- The patient must have fully recovered from any prior adverse effects related to anti-cancer treatments
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 |
|---|---|---|---|
| Shandong Cancer Hospital and Institute Coordinator of this site? Confirm its status | Jinan | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.