High-dose Chemotherapy as Second-line Drug Therapy for Relapsed Germ Cell Tumors

This is a prospective, single-center, non-randomized phase II study. Patients with germ cell tumors of gonadal and extragonadal localization who have progressed after prior platinum-containing first-line chemotherapy will receive high-dose chemotherapy with TI (2 cycles) folollowed by high dose CE chemotherapy with autologous stem cell transplantation (3 cycles). The primary endpoint of the study is to evaluate the efficacy high-dose chemotherapy as second-line drug therapy for patients with advanced germ cell tumors.

NCT Number	NCT06418789
Lead Sponsor	N.N. Petrov National Medical Research Center of Oncology
Conditions	Germ Cell Tumor
Enrollment	25 participants
Start Date	2024-03-01
Primary Completion	2029-03-01 (estimated)
Study Completion	2029-03-01 (estimated)
Updated on ClinicalTrials.gov	2025-08-03