Brief Title
An Open-label, Phase I/II Study of PLENA Regimen in Patients With Unresectable Pancreatic Cancer or BTC
Official Title
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
Brief 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).
Study Phase
Phase 1/Phase 2
Study Type
Interventional
Primary Outcome
Number of Subjects with treatment-related adverse events (AEs)
Secondary Outcome
Disease control rate (DCR)
Condition
Pancreatic Cancer
Intervention
Durvalumab
Study Arms / Comparison Groups
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.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
65
Start Date
April 12, 2022
Completion Date
April 30, 2024
Primary Completion Date
April 30, 2023
Eligibility Criteria
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.
Gender
All
Ages
18 Years - 75 Years
Accepts Healthy Volunteers
No
Contacts
Weidong Han, Dr, +861066937463, [email protected]
Location Countries
China
Location Countries
China
Administrative Informations
NCT ID
NCT05327582
Organization ID
CHN-PLAGH-BT-070
Responsible Party
Principal Investigator
Study Sponsor
Chinese PLA General Hospital
Study Sponsor
Weidong Han, Dr, Principal Investigator, Chinese PLA General Hospital
Verification Date
April 2022