NCT05327582

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

Status unknown Phase 1, PHASE2 Last updated 14 April 2022

What this trial tests

Phase 1, PHASE2 trial testing Durvalumab in Pancreatic Cancer in 65 participants. Status unknown.

Timeline

12 April 2022

Primary endpoint
30 April 2023

30 April 2024

Quick facts

Lead sponsor	Chinese PLA General Hospital
Phase	Phase 1, PHASE2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	65
Start date	12 April 2022
Primary completion	30 April 2023
Estimated completion	30 April 2024
Sites	1 location across China

Drugs / interventions tested

• Durvalumab — full drug profile →
• Lenvatinib (LENVATINIB) — full drug profile →
• Nab paclitaxel

Conditions studied

• Pancreatic Cancer — all drugs for Pancreatic Cancer →
• Biliary Tract Cancer — all drugs for Biliary Tract Cancer →

Sponsor

Chinese PLA General Hospital

Who can join

Adults 18 to 75, any sex, with Pancreatic Cancer or Biliary Tract Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Clinical Strategies Targeting the Tumor Microenvironment of Pancreatic Ductal Adenocarcinoma.
   Skorupan N, Palestino Dominguez M, Ricci SL, Alewine C. · · 2022 · cited 24× · PMID 36077755 · DOI 10.3390/cancers14174209
2. Targeting Angiogenesis in the Era of Biliary Tract Cancer Immunotherapy: Biological Rationale, Clinical Implications, and Future Research Avenues.
   Schirizzi A, De Leonardis G, Lorusso V, Donghia R, et al · · 2023 · cited 9× · PMID 37190304 · DOI 10.3390/cancers15082376
3. Emerging kinase inhibitors for the treatment of pancreatic ductal adenocarcinoma.
   Rudloff U. · · 2022 · cited 9× · PMID 36250721 · DOI 10.1080/14728214.2022.2134346
4. Cellular collusion: cracking the code of immunosuppression and chemo resistance in PDAC.
   Musiu C, Lupo F, Agostini A, Lionetto G, et al · · 2024 · cited 7× · PMID 38817612 · DOI 10.3389/fimmu.2024.1341079
5. Clinical Evaluation of the Pancreatic Cancer Microenvironment: Opportunities and Challenges.
   Szczepanski JM, Rudolf MA, Shi J. · · 2024 · cited 7× · PMID 38398185 · DOI 10.3390/cancers16040794
6. Molecular insights into immune evasion and therapeutic paradigms in pancreatic cancer.
   Li M, Zhou R, Qiu Y, Peng Y, et al · · 2025 · cited 1× · PMID 40642496 · DOI 10.21147/j.issn.1000-9604.2025.03.13
7. Threading the Needle: Navigating Novel Immunotherapeutics in Pancreatic Ductal Adenocarcinoma.
   Demir T, Moloney C, Mahalingam D. · · 2025 · cited 1× · PMID 40075563 · DOI 10.3390/cancers17050715
8. Mechanisms of Anti-PD Therapy Resistance in Digestive System Neoplasms.
   Wu Y, Jiang X, Yu Z, Xing Z, et al · · 2025 · PMID 38305306 · DOI 10.2174/0115748928269276231120103256