Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03764553 | Liposomal iRInotecan, Carboplatin or oXaliplatin for Esophagogastric Cancer | PHASE2 | ACTIVE NOT_RECRUITING | 320 | — | — | May 1, 2019 | Jul 1, 2026 | Apr 7, 2026 | 34 | Netherlands |
To compare the progression free survival
Number of participants with treatment-related Neurotoxicity according to CTCAE v4.0
| Arm | Type | Description |
|---|---|---|
| Liposomal irinotecan, leucovorin and 5FU | EXPERIMENTAL | IV Nal-IRI 80 mg/m² (expressed as irinotecan hydrochloride (HCl) salt), folinic acid 400 mg/m², fluorouracil 2400 mg/m² over 46 h, every 2 weeks. No addition of nivolumab is possible for this arm |
| Carboplatin and capecitabine | EXPERIMENTAL | IV and PO Capecitabine 1000 mg/m2 and carboplatin area under the curve (AUC5), every three weeks. In case of PD-L1 CPS ≥5 only: nivolumab, dose according to local standard, iv day 1 |
| oxaliplatin and capecitabine | EXPERIMENTAL | IV and PO Capecitabine 1000 mg/m2 and oxaliplatin 130 mg/m2, every three weeks. In case of PD-L1 CPS ≥5 only: nivolumab, dose according to local standard, iv day 1 |
| Name | Type | Description |
|---|---|---|
| Liposomal Irinotecan | DRUG | Iv liposomal irinotecan |
| Carboplatin | DRUG | IV Carboplatin |
| Capecitabine | DRUG | PO Capecitabine |
| Oxaliplatin | DRUG | IV Oxaliplatin |
| 5-fluorouracil | DRUG | IV 5-fluorouracil |
| Leucovorin | DRUG | IV Leucovorin |
Inclusion Criteria: * Patients must provide written informed consent according to International Conference on Harmonization (ICH)/Guideline for Good Clinical practice (GCP), and national/local regulations prior to any screening procedures. * Male or female adult patients (\> 18 years). * Patients w...