Thalidomide Combined With Chemotherapy in the Treatment of Relapsed or Refractory Yolk Sac Tumor

PHASE2CompletedINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

November 11, 2021

Primary Completion Date

June 16, 2024

Study Completion Date

June 16, 2024

Conditions
Germ Cell TumorYolk Sac Tumor
Interventions
DRUG

Thalidomide combined with TGA chemotherapy (nab-paclitaxel + gemcitabine+ epirubicin)

The oral dose of thalidomide is 1.5-2.5mg/kg/d daily (maximum 28g). Each cycle lasts for 21 days (every three weeks), and if treatment parameters are met as described in the study, cycle two and subsequent cycles begin on day 22. Treatment will be discontinued if there is drug-related dose-limiting toxicity or disease progression. Tumor response assessment will be repeated using AFP and LDH every one cycle and imaging examination every two cycles. Children who complete the trial may continue this regimen or undergo surgery or radiation therapy if their disease goes into remission.

Trial Locations (1)

250117

Shandong Cancer Hospital and Institute, Jinan

All Listed Sponsors
lead

Shandong First Medical University

OTHER

NCT06470464 - Thalidomide Combined With Chemotherapy in the Treatment of Relapsed or Refractory Yolk Sac Tumor | Biotech Hunter | Biotech Hunter