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
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- Number of Subjects with treatment-related adverse events (AEs)
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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-
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Durvalumab (Drug)
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.
干预措施: Lenvatinib (Drug)
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.
干预措施: Nab paclitaxel (Drug)
结局指标
主要结局
Number of Subjects with treatment-related adverse events (AEs)
时间窗: 6 months
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.
Object response rate (ORR)
时间窗: 12 months
ORR is defined as the proportion of subjects who achieved a partial response (PR) or complete response (CR) according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
次要结局
- Disease control rate (DCR)(12 months)
- Progression-free survival (PFS)(12 months)
- Overall survival (OS)(24 months)
- Number of participants with laboratory test abnormalities(12 months)
研究者
Han weidong
Principal Investigator
Chinese PLA General Hospital