Clinical Study of Chemotherapy in the Treatment of Recurrent/Refractory Yolk Sac Tumor in Children

Last updated: March 26, 2024
Sponsor: Shandong First Medical University
Overall Status: Completed

Phase

2/3

Condition

Germ Cell Tumors

Genitourinary Cancer

Brain Tumor

Treatment

sirolimus combined with chemotherapy in the treatment of recurrent/refractory yolk sac tumor in children

Clinical Study ID

NCT06341998
HERO2020
  • Ages 1-18
  • All Genders

Study Summary

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).

Eligibility Criteria

Inclusion

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 14 years old at the time of study participation.
  3. The child must be resistant to at least two platinum-containing chemotherapy regimentsor have relapse within 3 months of chemotherapy.
  4. The child must have measurable lesions (recorded according to RECIST criteria) ornon-evaluable disease with tumor marker AFP greater than 5 times the upper limit ofnormal.
  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% orBNP < 2000pg/ml); Liver function: alanine aminotransferase increased less than 5times the upper limit of normal, bilirubin increased less than 3 times the upper limitof 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

Exclusion Criteria:

  1. Patients with other tumors.
  2. Heart, brain, liver, kidney and other organ failure patients.

Study Design

Total Participants: 32
Treatment Group(s): 1
Primary Treatment: sirolimus combined with chemotherapy in the treatment of recurrent/refractory yolk sac tumor in children
Phase: 2/3
Study Start date:
June 01, 2020
Estimated Completion Date:
February 01, 2024

Study Description

According to the latest relevant foreign case analysis reports and clinical trial results, the TIP regimen remains the recommended treatment for patients with recurrent and refractory malignant germ-cell tumors based on previous data. Carboplatin has been proven effective and less toxic in children with MGCTs, while cisplatin is more commonly used in early stages. In our research group's previously explored TIC scheme (albumin paclitaxel + ifosfamide + carboplatin), cisplatin is often substituted with carboplatin. Additionally, albumin paclitaxel replaces traditional paclitaxel due to its lower adverse reaction rate and higher tumor tissue uptake accumulation, forming the TIC regimen. Our preliminary clinical work has shown that the TIC regimen effectively improves remission rates of recurrent refractory germ cell tumors, particularly yolk sac tumors. For a small number of children who are not responsive to the TIC regimen, combining Sirolimus (an mTOR inhibitor) significantly enhances remission rates of recurrent refractory yolk sac tumors. This approach can potentially lead to cure or achieve surgery and radiotherapy within a curative timeframe. Therefore, this study aims to determine the efficacy of combining mTOR inhibitor Sirolimus with the TIC chemotherapy regimen (albumin-paclitaxel + isocyclophosphamide + carboplatin) in treating recurrent or refractory vitelline cyst tumors, providing a novel and effective therapeutic option for children with recurrent and refractory MGCTs.

Connect with a study center

  • Shandong Cancer Hospital and Institute

    Jinan, Shandong 250117
    China

    Site Not Available

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