NCT06470464CompletedPhase 2
Thalidomide Combined With Chemotherapy in the Treatment of Relapsed or Refractory Yolk Sac Tumor
Clinical Study of Thalidomide Combined With Chemotherapy in the Treatment of Relapsed or Refractory Yolk Sac Tumor in Children
Source: ClinicalTrials.gov · Last updated 18 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 thalidomide with nab-paclitaxel, gemcitabine, and epirubicin (T-TGA) for children with repeated relapsed or refractory yolk sac tumor (rrrYST).
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 20 (actual)
- First submitted
- 17 Jun 2024
- Start date
- 11 Nov 2021
- Primary completion date
- 16 Jun 2024
- Lead sponsor
- Shandong First Medical University
- Diseases
- Childhood cancers
- NCT number
- NCT06470464
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 20
- From 11 Nov 2021 to the primary completion date, 16 Jun 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.
Other illness
- Heart, brain, liver, kidney and other organ failure patients.
Other
- Patients with other tumors.
Who the study is looking for
- The child must have histological evidence of an extracranial malignant germ cell tumor (vitelline sac tumor).
- Children must be no more than 18 years old at the time of study participation.
- The patients were children with vitelline cystic tumor who were resistant to drugs after at least two platinum-containing chemotherapy regimes or whose disease recurred within 3 months after chemotherapy regimes, or who recurred again or repeatedly after treatment with Sirolimus combined with TIC chemotherapy regimes.
- The child must have measurable lesions (recorded according to RECIST criteria) or non-evaluable disease with tumor marker AFP greater than 5 times the upper limit of normal.
- Lansky performance status score ≥50.
- The life expectancy of the child must exceed 6 weeks.
- The child must have recovered from the response to all previous anticancer treatments.
- No serious organ dysfunction: normal cardiac function (ejection fraction \> 50% or BNP \< 2000pg/ml); Liver function: alanine aminotransferase increased less than 5 times the upper limit of normal, bilirubin increased less than 3 times the upper limit of normal; Renal function: creatinine and urea nitrogen levels below the normal range; The white blood cells were greater than 3×109/L, and the platelets were greater than 100×109/L.
- Obtain the informed consent of the guardian and sign the informed consent.
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.