Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Biliary Tract Cancer | Malignant Biliary Tract Neoplasm | ALIAS | 0.90 |
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Durvalumab | Drug | Durvalumab | ALIAS |
| Lenvatinib | Drug | Lenvatinib | ALIAS |
| Nab paclitaxel | Drug | Nab-paclitaxel | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- PLENA regimen
- description
- Subject received PLENA regimen every 3 weeks until achieving a second assessable complete response or up to a maximum of 8 cycles. Treatment continued until progressive disease or intolerable toxicity, or withdrawal of consent.
- interventionNames
- Drug: Durvalumab
- Drug: Lenvatinib
- Drug: Nab paclitaxel
Primary outcomes (2)
- measure
- Number of Subjects with treatment-related adverse events (AEs)
- timeFrame
- 6 months
- description
- Incidence, nature, and severity of adverse events graded according to the NCI CTCAE v5.0. AEs were considered to be treatment-related if they had started or worsened within the interval from first study drug administration until the follow-up visit.
- measure
- Object response rate (ORR)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1.Subjects must have histologically proven unresectable pancreatic cancer or biliary tract cancer 2.18 to 75 years old. 3.Life expectancy of at least 6 months. 4.Eastern Cooperative Oncology Group performance status 0-2. 5.Subjects must have at least one measurable lesion ≥ 1 cm as defined by response criteria. 6.Subjects with Anti-PD-1/L1 antibody treatment history are eligible which must be disease progression. 7.Adequate organ function. 8.Participants of childbearing potential must be willing to use an adequate method of contraception for the course of the study through 120 days after the last dose of study drug. Exclusion Criteria: 1. Subjects with any autoimmune disease or history of syndrome that requires corticosteroids or immunosuppressive medications. 2. Serious uncontrolled medical disorders or active infections, pulmonary infection especially. 3. Prior organ allograft. 4. Women who are pregnant or breastfeeding. 5. Women with a positive pregnancy test on enrollment or prior to investigational product administration. 6. Subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness.
References
Publications (0)
Data not yet available