NCT06405490招募中2 期

Nanoliposomal Irinotecan and XELOX (NALIRI-XELOX) in Combination With Cadonilimab for First-Line Treatment of Patients With Locally Advanced or Metastatic Pancreatic Ductal Adenocarcinoma : A Single-arm, Phase II Study

Cancer Institute and Hospital, Chinese Academy of Medical Sciences1 个研究点分布在 1 个国家目标入组 30 人开始时间: 2024年4月17日最近更新: 2024年12月24日

适应症

干预措施

试验速览

阶段: 2 期
状态: 招募中
发起方: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
入组人数: 30
试验地点: 1
主要终点: Objective Response Rate (ORR)

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This study is a single-center, Phase II Study to assess the efficacy and safety of the regimen of Nanoliposomal Irinotecan and XELOX (NALIRI-XELOX) in combination with Cadonilimab in subjects with advanced pancreatic ductal adenocarcinoma who have not previously received systemic treatment.

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 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Age ≥18, male or female;
•Has histologically or cytologically confirmed pancreatic ductal adenocarcinoma (PDAC);
•Has not received prior systemic treatment for their locally advanced or metastatic PDAC;
•Has presence of measurable disease as defined by Response Evaluation Criteria in Solid Tumours (RECIST 1.1);
•Has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Status;
•Has a life expectancy of at least 3 months;
•Has adequate organ function;
•If female of childbearing potential, have a negative serum pregnancy test within 7 days prior to first trial treatment;
•If female of childbearing potential or a male subject with a partner with childbearing potential, be willing to use a highly effective method of contraception (with a failure rate of less than 1.0% per year) from first study treatment to 24 weeks after completion of the trial treatment.

排除标准

•Untreated active CNS metastasis or leptomeningeal metastasis.
•Is currently participating and receiving an investigational drug or has participated in a study of an investigational drug within 4 weeks or within 5 times of half-life (no less than 2 weeks), whichever is shorter prior to the first dose of trial treatment;
•Has received other anti-tumor treatment within 4 weeks or within 5 times of half-life (no less than 2 weeks), whichever is shorter prior to the first trial treatment;
•Major surgery for any reason, except diagnostic biopsy, within 4 weeks of the first administration of trial treatment and/or if the subject has not fully recovered from the surgery within 4 weeks of the first administration of trial treatment;
•Curative radiation within 3 months of the first dose of trial treatment. Radiation to more than 30% of the bone marrow or with a wide field of radiation should not be used within 4 weeks prior to the first administration of trial treatment;
•Subjects receiving immunosuppressive agents (such as steroids) for any reason should be tapered off these drugs before initiation of trial treatment (with the exception of subjects with adrenal insufficiency, who may continue corticosteroids at physiologic replacement doses, equivalent to < 10 mg prednisone daily, inhaled steroids and topical use of steroids);
•Vaccination within 28 days of the first administration of trial treatment, except for administration of inactivated vaccines (e.g., inactivated influenza vaccines);
•Has interstitial lung disease, or a history of pneumonitis that required oral or intravenous glucocorticoids to assist with management;
•History or current active autoimmune disease that might deteriorate when receiving an immunostimulatory agent；
•Previous malignant disease History of uncontrolled intercurrent illness Prior therapy with any antibody/drug targeting T cell coregulatory proteins Known severe hypersensitivity reactions to antibody drug；
•Is pregnant or breastfeeding;
•Other medical conditions that at the discretion of investigator interfere with the requirements of the trial in terms of safety or efficacy evaluation, or treatment compliance.

研究组 & 干预措施

NALIRI-XELOX+AK104

Experimental

Every 2 weeks as a cycle:

Nanoliposomal Irinotecan: 47.1mg/m2, iv, d1;
Cadonilimab: 6mg/kg, iv, d3;
Oxaliplatin: 70mg/m2, iv, d1;
Capecitabine: 1000mg/m2, bid, po, d1-d7; Re-evaluate patients every three cycles. If the patient has been treated for more than 9 cycles, they will enter maintenance therapy, and the regimen is capecitabine +Cadonilimab.

干预措施: Nanoliposomal Irinotecan+Oxaliplatin +Capecitabine+Cadonilimab (Drug)

结局指标

主要结局

Objective Response Rate (ORR)

时间窗: 2 years

ORR of regimen of NALIRI-XELOX+AK104

次要结局

Disease Control Rate (DCR)(2 years)
12-month PFS rate(12 months)
Duration of Response (DoR)(2 years)
Median Overall Survival (mOS)(2 years)
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] Adverse Events (AEs) Incidence, Serious Adverse Events (SAE) Incidence(2 years)
Median Progression-Free Survival (mPFS)(1 years)

研究者

发起方

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

申办方类型

Other

责任方

Principal Investigator

主要研究者

LIN YANG

chief physician

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

研究点 (1)

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