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

PHASE2/PHASE3CompletedINTERVENTIONAL
Enrollment

32

Participants

Timeline

Start Date

June 1, 2020

Primary Completion Date

January 1, 2024

Study Completion Date

February 1, 2024

Conditions
Germ Cell TumorYolk Sac Tumor
Interventions
DRUG

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

The planned treatment protocol comprised four cycles of the S-TIC regimen, which included sirolimus administered orally at a dose of 1 mg/m² from day 1 to day 21-28, nab-paclitaxel at a dose of 200 mg/m² on day 1, ifosfamide at a dose of 1200 mg/m² from day 2 to day 5, and carboplatin at a dose of 400 mg/m² on day 2. Additionally, mesna and sulfamethoxazole were prescribed to prevent hemorrhagic cystitis and Pneumocystis Jirovecii Pneumonia (PJP), respectively. Each cycle spanned a duration of three to four weeks. AFP levels were evaluated at the end of each cycle, and radiological assessments were conducted every two cycles. Surgical intervention decisions were made based on the results of these assessments.

Trial Locations (1)

250117

Shandong Cancer Hospital and Institute, Jinan

All Listed Sponsors
lead

Shandong First Medical University

OTHER

NCT06341998 - Clinical Study of Chemotherapy in the Treatment of Recurrent/Refractory Yolk Sac Tumor in Children | Biotech Hunter | Biotech Hunter