An Open-label, Phase I/II Study of PLENA Regimen in Patients With Unresectable Pancreatic Cancer or BTC
Status:
Recruiting
Trial end date:
2024-04-30
Target enrollment:
Participant gender:
Summary
Immunotherapy of cancer based on PD-1/PD-L1 blockade has prompted a revolution in cancer
clinical management, albeit as yet immunotherapy-based treatment approaches in pancreatic
cancer and biliary tract cancer (BTC) remain to have proven value, highlights the urgency for
designing novel therapeutic strategies to combat these deadly diseases. The immunomodulatory
effect of lenvatinib (Lenvatinib is an oral multi-kinase inhibitor) on tumor
microenvironments may contribute to antitumor activity of immune checkpoint blockade. This
one-arm, phase I/II study is designed to assess the safety and efficacy of the combined
regimen of Durvalumab (anti-PD-L1 antibody), Lenvatinib and Paclitaxel albumin
(nab-paclitaxel).