Clinical trial · Interventional
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Germ Cell Tumor | Germ Cell Tumor | ONTOLOGY_EXACT | 0.90 |
| Yolk Sac Tumor | Yolk Sac Tumor | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Thalidomide combined with TGA chemotherapy (nab-paclitaxel + gemcitabine+ epirubicin) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- thalidomide combined with chemotherapy in the treatment of relapsed or refractory yolk sac tumor
- description
- This study employed an open single-group clinical laboratory design method (Simon Phase II study) to investigate the efficacy and safety of combining thalidomide with TGA chemotherapy (nab-paclitaxel + gemcitabine+ epirubicin) in the treatment of children with recurrent or refractory YST. AFP levels were assessed after each course of treatment, while imaging evaluations were conducted every two courses. The remission rate following chemotherapy in this single-group clinical trial was compared to that reported in the literature for treating recurrent or refractory yolk sac tumor, evaluating overall remission rate (ORR) and event-free survival rate (EFS), as well as monitoring and recording chemotherapy-related side effects.
- interventionNames
- Drug: Thalidomide combined with TGA chemotherapy (nab-paclitaxel + gemcitabine+ epirubicin)
Primary outcomes (1)
- measure
- Overall Response Rate (ORR)
- timeFrame
- Every 3 weeks per cycle, up to 6 cycles
- description
- Proportion of participants achieving partial or complete response,Measurement: Imaging (CT/MRI) every 2 cycles per RECIST 1.1;Serum AFP reduction ≥90% from baseline.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Year
- Maximum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. The child must have histological evidence of an extracranial malignant germ cell tumor (vitelline sac tumor). 2. Children must be no more than 18 years old at the time of study participation. 3. 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. 4. 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. 5. Lansky performance status score ≥50. 6. The life expectancy of the child must exceed 6 weeks. 7. The child must have recovered from the response to all previous anticancer treatments. 8. 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. 9. Obtain the informed consent of the guardian and sign the informed consent. Exclusion Criteria: 1. Patients with other tumors. 2. Heart, brain, liver, kidney and other organ failure patients.
References
Publications (0)
Data not yet available