HR070803 in Combination With Oxaliplatin Plus Tegafur Versus HR070803 in Combination With Oxaliplatin, 5-fluorouracil, Calcium Folinate as Adjuvant Therapy for Pancreatic Cancer: A Multicenter, Multi-cohort, Randomized, Phase II Study
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 120
- 主要终点
- 1-year Disease-free survival rate
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of HR070803 in Combination With Oxaliplatin plus Tegafur compared to HR070803 in combination with oxaliplatin, 5-fluorouracil/leucovorin (5FU/LV) 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 1-year disease-free survival rate. 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 the Disease-free survival.
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
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed resected ductal pancreatic adenocarcinoma with macroscopic complete resection (R0 and R1).
- •ECOG performance status 0 or
- •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.
- •The number of lymph nodes dissected during resection ≥
- •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.
- •CA19-9 exceeding normal value within 14 days prior to enrollment.
- •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+S-1
Drug: HR070803（Irinotecan Liposome）; Oxaliplatin; Tegafur HR070803 60 mg/^2 D1 over 90 minutes. Oxaliplatin 85 mg/^2 D1 over 2 hours. Tegafur The initial dose of S-1 is determined according to the body surface area，orally, D1-7.
These drugs are given once every 2 weeks, 4 weeks as one cycle, 6 treatment cycles.
干预措施: HR070803 (Drug)
HR070803+Oxaliplatin+S-1
Drug: HR070803（Irinotecan Liposome）; Oxaliplatin; Tegafur HR070803 60 mg/^2 D1 over 90 minutes. Oxaliplatin 85 mg/^2 D1 over 2 hours. Tegafur The initial dose of S-1 is determined according to the body surface area，orally, D1-7.
These drugs are given once every 2 weeks, 4 weeks as one cycle, 6 treatment cycles.
干预措施: Oxaliplatin (Drug)
HR070803+Oxaliplatin+S-1
Drug: HR070803（Irinotecan Liposome）; Oxaliplatin; Tegafur HR070803 60 mg/^2 D1 over 90 minutes. Oxaliplatin 85 mg/^2 D1 over 2 hours. Tegafur The initial dose of S-1 is determined according to the body surface area，orally, D1-7.
These drugs are given once every 2 weeks, 4 weeks as one cycle, 6 treatment cycles.
干预措施: Tegafur (Drug)
HR070803+Oxaliplatin+5-FU/LV
Drug: HR070803; Oxaliplatin; 5-Fluorouracil; Calcium folinate HR070803 60 mg/^2 D1 over 90 minutes. Oxaliplatin 85 mg/^2 D1 over 2 hours. Folinic acid 400 mg/^2 D1, IV infusion over 1 hours. 5-FU 2400 mg/^2 D1 IV continuous infusion over 46 hours.
These drugs are given once every 2 weeks, 4 weeks as one cycle, 6 treatment cycles.
干预措施: HR070803 (Drug)
HR070803+Oxaliplatin+5-FU/LV
Drug: HR070803; Oxaliplatin; 5-Fluorouracil; Calcium folinate HR070803 60 mg/^2 D1 over 90 minutes. Oxaliplatin 85 mg/^2 D1 over 2 hours. Folinic acid 400 mg/^2 D1, IV infusion over 1 hours. 5-FU 2400 mg/^2 D1 IV continuous infusion over 46 hours.
These drugs are given once every 2 weeks, 4 weeks as one cycle, 6 treatment cycles.
干预措施: Oxaliplatin (Drug)
HR070803+Oxaliplatin+5-FU/LV
Drug: HR070803; Oxaliplatin; 5-Fluorouracil; Calcium folinate HR070803 60 mg/^2 D1 over 90 minutes. Oxaliplatin 85 mg/^2 D1 over 2 hours. Folinic acid 400 mg/^2 D1, IV infusion over 1 hours. 5-FU 2400 mg/^2 D1 IV continuous infusion over 46 hours.
These drugs are given once every 2 weeks, 4 weeks as one cycle, 6 treatment cycles.
干预措施: Folinic acid (Drug)
HR070803+Oxaliplatin+5-FU/LV
Drug: HR070803; Oxaliplatin; 5-Fluorouracil; Calcium folinate HR070803 60 mg/^2 D1 over 90 minutes. Oxaliplatin 85 mg/^2 D1 over 2 hours. Folinic acid 400 mg/^2 D1, IV infusion over 1 hours. 5-FU 2400 mg/^2 D1 IV continuous infusion over 46 hours.
These drugs are given once every 2 weeks, 4 weeks as one cycle, 6 treatment cycles.
干预措施: 5-Fluorouracil (Drug)
结局指标
主要结局
1-year Disease-free survival rate
时间窗: Up to 2 years
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
- Overall survival (OS)(Up to 2 years)
- Disease-free survival（DFS）(Up to 2 years)