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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03257033 | Intra-arterial Gemcitabine vs. IV Gemcitabine and Nab-Paclitaxel Following Radiotherapy for LAPC | PHASE3 | RECRUITING | 190 | — | — | Mar 12, 2018 | Sep 1, 2026 | Nov 14, 2025 | 42 | United States, Belgium |
OS from time of randomization will be calculated using the Kaplan-Meier method and compared between the test and control groups using the stratified Wilcoxin Test
| Arm | Type | Description |
|---|---|---|
| IA Therapy | EXPERIMENTAL | IA Treatments with 1,000 mg/m2 gemcitabine administered through RenovoCath every other week for a maximum of 8 treatments for approximately 16 weeks. |
| IV Therapy | ACTIVE_COMPARATOR | IV gemcitabine and nab-paclitaxel will be administered for 16 weeks on days 1, 8, and 15 of a 28 day cycle. Nab-paclitaxel will be administered intravenously following pre-medication at a dose of 125 mg/m2 over 30 minutes followed by an infusion of gemcitabine at a dose of 1000 mg/m2 over 30 minutes. |
| Name | Type | Description |
|---|---|---|
| Gemcitabine | DRUG | Chemotherapy |
| nab-paclitaxel | DRUG | Chemotherapy |
| RenovoCath | DEVICE | Intra-arterial catheter |
Inclusion Criteria: 1. Histologically or Cytopathology confirmed pancreatic adenocarcinoma with initial diagnosis within 8 weeks of consent for patients who enroll at cycle 1, and from the start of cycle 1 of gemcitabine + nab-paclitaxel chemotherapy for patients who enroll at cycle 2 2. Locally ad...