Phase Ib/II Study to Evaluate the Safety and Efficacy of IBI363 in Combination With Chemotherapy as Second-Line Therapy for Unresectable Locally Advanced or Metastatic Pancreatic Cancer
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 48
- 主要终点
- Adverse events (AEs)
研究概览
简要总结
This study is an Ib/II phase clinical trial evaluating the safety and efficacy of IBI363 combined with chemotherapy as a second-line treatment for unresectable locally advanced or metastatic pancreatic cancer.
Approximately 39-48 patients with unresectable locally advanced or metastatic pancreatic cancer, who have progressed on or are intolerant to first-line chemotherapy (albumin-bound paclitaxel + gemcitabine, AG regimen), will be enrolled. Treatment involves IBI363 combined with chemotherapy and continues until disease progression, death, intolerable toxicity, withdrawal of informed consent, initiation of new antitumor therapy, or other protocol-specified reasons for discontinuation.
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
- •Signed written informed consent form (ICF)
- •Age 18-75 years
- •Histologically/cytologically confirmed, unresectable locally advanced or metastatic pancreatic cancer.
- •Disease progression or intolerance after first-line treatment with the AG regimen (gemcitabine + albumin-bound paclitaxel).
- •ECOG Performance Status(PS) score of 0-
- •At least one measurable lesion according to RECIST v1.1 criteria.
- •Adequate organ and bone marrow function
排除标准
- •Previous histologically/cytologically confirmed components including adenosquamous carcinoma, medullary carcinoma, signet ring cell carcinoma, undifferentiated carcinoma, etc.
- •Prior treatment with PD-1/PD-L1 inhibitors or other immunotherapies.
- •Unresolved > Grade 1 toxicities related to prior anticancer therapy (except persistent Grade 2 alopecia, anemia, peripheral neuropathy, correctable electrolyte abnormalities, or well-controlled endocrine disorders with hormone replacement therapy).
- •History of hepatic encephalopathy, seizures, active/new/untreated CNS metastases, spinal compression, carcinomatous meningitis, or leptomeningeal metastases.
- •Clinically significant cardiovascular/cerebrovascular diseases
- •Known hypersensitivity to IL-2, sintilimab, or monoclonal antibody components
结局指标
主要结局
Adverse events (AEs)
时间窗: Up to approximately 36 months
Progression-Free Survival(PFS)
时间窗: Up to approximately 6 months
次要结局
- Objective Response Rate (ORR)(Up to approximately 6 months)
- Disease control rate(DCR)(Up to approximately 6 months)
- Overall Survival(OS)(Up to approximately 12 months)