OncoMatch/Clinical Trials/NCT07847190
Paclitaxel-Bleomycin/Etoposide/Cisplatin vs Bleomycin/Etoposide/Cisplatin in Poor-prognosis Non-seminomatous Germ Cell Tumors (NSGCT) and Unfavorable Tumor Marker Decline: Randomized Phase II Trial
Official title: Paclitaxel+BEP (T-BEP) vs BEP in Poor-prognosis Non-seminomatous Germ Cell Tumors (NSGCT) and Unfavorable Tumor Marker Decline: Randomized Phase II Trial
Is NCT07847190 recruiting? Yes, currently enrolling (Oct 2026). This Phase 2 trial studies multiple treatments for germ cell cancer metastatic.
Treatment: Paclitaxel · Bleomycin · Etoposide · Cisplatin · G-CSF (Filgrastim) — GETUG-13 study has prospectively confirmed poor outcomes in advanced germ cell tumors (GCT) patients with unfavorable decrease of tumor markers after 1 cycle of BEP chemotherapy. There is an unmet medical need to improve outcomes in this subset of patients, however the dose-dense regimen proposed in the above-mentioned trial cannot be implemented in routine clinical practice. T-BEP regimen may have advantage over the traditional BEP regimen as first-line therapy for poor-risk GCT Treatment escalation with T-BEP regimen may be an effective and tolerable therapeutic option for advanced GCT patients with unfavorable tumor markers decline.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Chemotherapy
Other
Cancer type
Testicular Germ Cell Tumor
Biomarker criteria
Required: CGB expression (HCG > 50,000 UI/l)
HCG > 50,000 UI/l
Required: AFP expression (AFP > 10,000 ng/ml)
AFP > 10,000 ng/ml
Required: LDHA expression (LDH > 10 times the upper normal value)
LDH > 10 times the upper normal value
Disease stage
Required: Stage POOR PROGNOSIS ACCORDING TO IGCCCG CRITERIA (other)
Disease classified as poor prognosis according to IGCCCG criteria
Demographics
Prior therapy
Lab requirements
Blood counts
absolute baseline granulocyte count ≥0.5*10^9, platelets ≥100*10^9
Kidney function
measured or calculated glomerular filtration rate > 60 ml/min
Liver function
bilirubin ≤1.5 uln
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT07847190 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Does this trial require CGB?
Yes, CGB expression is a required biomarker for enrollment.
Does this trial require AFP?
Yes, AFP expression is a required biomarker for enrollment.
Does this trial require LDHA?
Yes, LDHA expression is a required biomarker for enrollment.
What disease stage is eligible?
Stage POOR PROGNOSIS ACCORDING TO IGCCCG CRITERIA is required.
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