drugset / Trial / NCT03468335
2nd-line Therapy With Nal-IRI After Gem/Nab-pac in Advanced Pancreatic Cancer - Predictive Role of 1st-line Therapy
Phase 3
Completed
151 enrolled
AIO-Studien-gGmbH
Crolll Gmbh · collabServier Deutschland GmbH · collab
NaSingle-groupOpen-labelTreatment
Summary
Second-line therapy with Nal-IRI after failure gemcitabine/nab-paclitaxel in advanced pancreatic cancer - predictive role of 1st-line therapy
Timeline
- Start
- 2018-03-31
- Primary completion
- 2022-05-31
- Completion
- 2022-05-31
Publications
- Lutz MP, Ansorge N, Barmashenko G, Bauer H, Burkart C, Decker T, Ettrich T, Fischer von Weikersthal L, Geer T, Gerhardt A, Hofling S, Jacobasch L, Koenigsmann M, Leidig T, Plentz R, Rath S, Reichert D, Schulte M, Schulte N, Schwarzer A, Siegler G, Waldschmidt D, Karthaus M. Predictive criteria for overall survival and treatment duration of 2nd-line chemotherapy in patients with advanced pancreatic adenocarcinoma (AIO-PAK-0216). Br J Cancer. 2026 Jan;134(1):85-91. doi: 10.1038/s41416-025-03188-x. Epub 2025 Oct 14.
- Lahusen A, Lutz MP, Fang R, Kirchner M, Albus S, Kluck K, Karthaus M, Schwarzer A, Siegler G, Kleger A, Ettrich TJ, Becher A, Hofling S, Siveke JT, Budczies J, Tannapfel A, Stenzinger A, Cheung PF, Eiseler T, Seufferlein T. An immune responsive tumor microenvironment imprints into PBMCs and predicts outcome in advanced pancreatic cancer: lessons from the PREDICT trial. Mol Cancer. 2025 Jul 22;24(1):202. doi: 10.1186/s12943-025-02406-7.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Irinotecan | Small molecule | 70 mg/m2 | — |
| Background | Leucovorin | Small molecule | 400 mg/m2 | — |
| Background | fluorouracil | Small molecule | 2400 mg/m2 | — |