OncoMatch/Clinical Trials/NCT06418789
High-dose Chemotherapy as Second-line Drug Therapy for Relapsed Germ Cell Tumors
Is NCT06418789 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies High-dose chemotherapy (TI- 2 cycles, CE- 3 cycles ) for germ cell tumor.
Treatment: High-dose chemotherapy (TI- 2 cycles, CE- 3 cycles ) — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Testicular Germ Cell Tumor
Demographics
Prior therapy
Must have received: platinum-based chemotherapy (BEP, EP) — first-line
Progression after 3 or 4 cycles of platinum-containing first-line chemotherapy (ВЕР or EP)
Cannot have received: any drug therapy for disseminated GO
Exception: ≤1 prior line allowed
Administration of ≥2 lines of prior drug therapy for disseminated GO
Lab requirements
Blood counts
Hemoglobin ≥ 90 g/L; neutrophils ≥ 1.5 x 10^9/L; platelets ≥ 75 x 10^9/L
Kidney function
creatinine ≥ 1.5 x HGH (or CKF ≤ 60 mL/min)
Liver function
ALT or AST ≥ 2.5 x HGN (5 x HGN for patients with liver metastases); bilirubin ≥ 1.5 x IUH (except for patients with Gilbert syndrome, in whom total bilirubin levels should not exceed 50 μmol/L); alkaline phosphatase ≥ 2.5 x IUH
Required Initial Laboratory Values: Hemoglobin ≥ 90 g/L; neutrophils ≥ 1.5 x 10^9/L; platelets ≥ 75 x 10^9/L; creatinine ≥ 1.5 x HGH (or CKF ≤ 60 mL/min); ALT or AST ≥ 2.5 x HGN (5 x HGN for patients with liver metastases); bilirubin ≥ 1.5 x IUH (except for patients with Gilbert syndrome, in whom total bilirubin levels should not exceed 50 μmol/L); alkaline phosphatase ≥ 2.5 x IUH.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT06418789 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior any drug therapy for disseminated GO disqualifies patients from enrollment.
Is this trial open to female patients?
No. This trial enrolls male patients only.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages