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

Sponsor
Chinese PLA General Hospital
Study ID
NCT05327582
Phase
PHASE1/PHASE2
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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).

Key Dates

Start date
Apr 12, 2022
Status verified
Apr 2022
Primary completion
Apr 30, 2023
Completion
Apr 30, 2024

Study Design

Enrollment
65 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Number of Subjects with treatment-related adverse events (AEs) [ Time Frame: 6 months ]

Central Contacts

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