NCT05327582

An Open-label, Phase I/II Study of PLENA Regimen in Patients With Unresectable Pancreatic Cancer or BTC

A Phase I/II, Open-label, One-arm, Single-center Study to Evaluate the Safety and Efficacy of the PLENA Regimen in Subjects With Unresectable Pancreatic Cancer or Biliary Tract Cancer

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 65 (estimated)
• Sponsor: Chinese PLA General Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Pancreatic Cancer
• Biliary Tract Cancer

Interventions

Type	Name	Description
DRUG	Durvalumab	Administered intravenously, 1000 mg on day 1 in a 3-week cycle
DRUG	Lenvatinib	Administered orally, 8mg/d once daily in a 3-week cycle
DRUG	Nab paclitaxel	Administered intravenously, 180-220 mg/m2 on day1 in a 3-week cycle

Timeline

• Start date: 2022-04-12
• Primary completion: 2023-04-30
• Completion: 2024-04-30
• First posted: 2022-04-14
• Last updated: 2022-04-14

Locations

1 site across 1 country: China