HR070803 in Combination With Oxaliplatin, 5-fluorouracil, Calcium Folinate Versus Gemcitabine in Combination With Capecitabine as Adjuvant Therapy for Pancreatic Cancer: an Open, Randomized, Multicenter Phase III Trial.
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 524
- 试验地点
- 1
- 主要终点
- Disease-free survival (DFS)
研究概览
简要总结
The purpose of this study is to look at the efficacy and safety of HR070803 in combination with 5 fluorouracil/leucovorin (5FU/LV) plus oxaliplatin compared to gemcitabine + capecitabine treatment as adjuvant therapy in patients with resected pancreatic cancer.
详细描述
STUDY DESIGN/ Evaluation criteria Main criterion: efficacy. The main criterion is the disease-free survival. Disease-free survival is defined as the time from date of randomization until the date of the first cancer-related event, second cancer, or death from any cause. Patients without event at the time of analysis will be censored at the date of last follow-up visit.
Secondary criteria include Overall survival. OS is defined as the time from date of randomization until the date of death from any cause. Patients who are still living at the time of analysis will be censored at the date of last follow-up visit.
Secondary criteria also include 3-year disease-free survival rate/overall survival rate and 5-year disease-free survival rate/overall survival rate.
Tolerance Patients evaluable for toxicity must have received one investigational drug.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ECOG performance status 0 or 1
- •Histologically confirmed resected ductal pancreatic adenocarcinoma with macroscopic complete resection (R0 and R1).
- •Life expectancy of greater than or equal to 6 months.
- •Full recovery from surgery and patient is scheduled to start treatment within 3 weeks to 12 weeks after surgery.
- •Acceptable hematology parameters and blood chemistry levels.
- •Able and willing to provide a written informed consent.
排除标准
- •Patients with pancreatic cancer originating from extrapancreatic ductal epithelium, including pancreatic neuroendocrine carcinoma, acinar cell carcinoma of the pancreas, pancreatoblastoma, and solid-pseudopapillary tumor;
- •Presence of or history of metastatic or locally recurrent pancreatic adenocarcinoma.
- •CA 19-9> 180 U / ml within 21 days of registration on study.
- •Prior neo-adjuvant treatment, radiation therapy, or systemic therapy for pancreatic adenocarcinoma.
- •Severe infection (> CTCAE grade 2), such as severe pneumonia, bacteremia, infection complications, etc. requiring inpatient treatment, occurred within four weeks before enrollment, and symptoms and signs of infection requiring intravenous antibiotic therapy (except for prophylactic antibiotics) occurred within two weeks before enrollment;
- •Patients with cardiac clinical symptoms or diseases that are not well controlled, such as: (1) Patients with NYHA class 2 and above cardiac failure; (2) unstable angina; (3) myocardial infarction that occurred within 6 months; (4) clinically significant supraventricular or ventricular arrhythmia requiring treatment or intervention.
研究组 & 干预措施
HR070803+Oxaliplatin+5-FU/LV
HR070803; Oxaliplatin; 5Fluorouracil; Calcium folinate
干预措施: HR070803; Oxaliplatin; 5Fluorouracil; Calcium folinate (Drug)
GX
gemcitabine; capecitabine
干预措施: gemcitabine; capecitabine (Drug)
结局指标
主要结局
Disease-free survival (DFS)
时间窗: From study start until 338 DFS events have occurred (approximately 21 months after last patient enrollment)
Disease-free survival is defined as the time from date of randomization until the date of the first cancer-related event, second cancer, or death from any cause.
次要结局
- 3-year disease-free survival rate(up to 36 months following the date the first patient was randomized)
- Overall survival (OS)(From date of randomization until the date of death from any cause, assessed up to 37 months)
- 5-year disease-free survival rate(up to 60 months following the date the first patient was randomized)
- 3-year overall survival rate(up to 36 months following the date the first patient was randomized)
- 5-year overall survival rate(up to 60 months following the date the first patient was randomized)