An Open-label, Phase I/II Study of PLENA Regimen in Patients With Unresectable Pancreatic Cancer or BTC
Pancreatic Cancer, Biliary Tract Cancer
About this trial
This is an interventional treatment trial for Pancreatic Cancer focused on measuring unresectable, anti-PD-L1 antibody, lenvatinib, nab-paclitaxel
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:
- Subjects with any autoimmune disease or history of syndrome that requires corticosteroids or immunosuppressive medications.
- Serious uncontrolled medical disorders or active infections, pulmonary infection especially.
- Prior organ allograft.
- Women who are pregnant or breastfeeding.
- Women with a positive pregnancy test on enrollment or prior to investigational product administration.
- Subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness.
Sites / Locations
- Biotherapeutic Department of Chinese PLA General HospitalRecruiting
Arms of the Study
Arm 1
Experimental
PLENA regimen
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.