NCT06532617招募中2 期
A Single-arm Phase II Clinical Study of Cadonilimab Combined With S-1 or Capecitabine as Second-line Treatment for Patients With Advanced Pancreatic Cancer
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年9月19日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Objective response rate (ORR)
研究概览
简要总结
This is a single arm, single cencer, phase II clinical trial. This study aims to evaluate the efficacy and safety of Cadonilimab combined with S-1 or capecitabine as a second-line treatment for advanced pancreatic cancer.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed written informed consent
- •Age 18-80, female or male
- •Histopathologically confirmed pancreatic ductal adenocarcinoma
- •Patients with locally advanced pancreatic cancer who have previously received standard first-line anti-tumor treatment (radiotherapy, chemotherapy, targeted or immunotherapy, etc.)
- •Locally advanced pancreatic cancer is defined as follows: a. The tumor has no distant metastasis; b. Pancreatic head/uncinate process: The tumor contacts the superior mesenteric artery >180˚; c. Pancreatic body and tail: The tumor contacts the superior mesenteric artery or celiac artery >180˚; The tumor contacts the celiac artery and infiltrates the abdominal aorta; d. The tumor invades the jejunal branch of the superior mesenteric artery. Portal vein-superior mesenteric vein cannot be safely reconstructed due to tumor invasion, vein occlusion, or involvement of a large range of jejunal branches of the superior mesenteric vein.
- •At least one measurable lesion (RECIST1.1)
- •ECOG PS 0-1
- •Expected survival time>3 months
- •Adequate organ function
排除标准
- •Malignant diseases other than pancreatic cancer diagnosed within 5 years before the first dose (excluding radically resected basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and/or radically resected carcinoma in situ)
- •Currently participating in interventional clinical research treatment, or having received other research drugs or used research devices within 4 weeks before the first dose
- •Active autoimmune disease
- •Allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation
- •Allergic to the active ingredients or excipients of this study drug, cadonilimab, S-1 or capecitabine
- •Have not fully recovered from any toxicity and/or complications caused by the intervention before starting treatment
- •History of HIV
- •Active HBV or HCV
- •Pregnant or breastfeeding women
- •Any severe or uncontrolled systemic disease
- •Active pulmonary tuberculosis
- •People with mental disorders who are unable to cooperate with treatment
- •Uncontrolled infection
- •The investigators assess that the subjects are unable to complete the entire trial process or are otherwise unsuitable for participating in this trial
研究组 & 干预措施
Cadonilimab+S-1or Capecitabine
Experimental
干预措施: Cadonilimab+S-1or Capecitabine (Drug)
结局指标
主要结局
Objective response rate (ORR)
时间窗: Up to 2 years
Defined as the proportion of patients with a complete response or partial response to treatment according to RECIST1.1
次要结局
- Overall survival (OS)(Up to 2 years)
- Progression-free survival (PFS)(Up to 2 years)
- Duration of response (DoR)(Up to 2 years)
- Disease control rate (DCR)(Up to 2 years)
研究者
Jiang Long
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
研究点 (1)
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