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

Phase

2/3

Condition

Genitourinary Cancer

Neoplasms

Testicular Cancer

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：

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

Exclusion Criteria：

a history of previous tumors
organ failure, specifically involving the heart, brain, liver, or kidneys.

Study Design

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

2/3

June 01, 2020

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
Shandong Cancer Hospital and Institute
Jinan 1805753, Shandong 1796328 250117
China
Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.