NCT07691593尚未招募2 期
An Exploratory Clinical Study of HRS-4642 in Combination With Chemotherapy With or Without Adebrelimab as Neoadjuvant Therapy for Pancreatic Cancer
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 60
- 主要终点
- Adverse events (AEs)
研究概览
简要总结
To evaluate the safety and efficacy of neoadjuvant HRS-4642 plus chemotherapy with or without adebrelimab in patients with pancreatic ductal adenocarcinoma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female participants aged 18-70 (including those who are 18 and 70 years old)；
- •Pathologically or cytologically confirmed ductal adenocarcinoma of the pancreas; and subjects must have at least one measurable lesion as defined by Response Evaluation Criteria in Solid Tumors (RECIST, version 1.1);
- •Life expectancy ≥ 12 weeks;
- •Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1;
- •Adequate marrow and organ function;
排除标准
- •Prior receipt of any anti-tumor therapy, including but not limited to systemic chemotherapy, radiotherapy, interventional therapy, immunotherapy, targeted therapy, and anti-tumor traditional Chinese medicine therapy;
- •Presence of distant metastatic lesions confirmed by imaging;
- •Known hypersensitivity to the investigational drug or any of its excipients;
- •Presence of any serious or uncontrolled systemic disease;
- •History of allogeneic hematopoietic stem cell transplantation or solid organ transplantation;
- •Clinically significant acute or chronic pancreatitis;
- •Participation in any interventional clinical trial involving drugs or medical devices within 4 weeks prior to the first administration of study treatment;
- •Vaccination with live or live-attenuated vaccines within 4 weeks prior to the first dose of the investigational drug;
- •Any other condition that, in the judgment of the investigator, makes the subject unsuitable for enrollment.
结局指标
主要结局
Adverse events (AEs)
时间窗: From the first drug administration to within 30 days or within 60 days after the last dose of adebrelimab for the last dose
Objective Response Rate (ORR) based on Response Evaluation Criteria in Solid Tumors (RECIST, version 1.1)
时间窗: Once every 2 cycles from enrollment through the neoadjuvant and adjuvant therapy periods or until disease progression; the evaluation period is up to 6 months
次要结局
- Pathologic Complete Response Rate (pCR)(At the time of surgery)
- R0 (microscopically margin-negative) resection rate(At the time of surgery)
- Major Pathologic Response Rate (MPR)(At the time of surgery)
研究者
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