A Randomized, Open-label, Multi-center Phase III Clinical Study of Liposomal Irinotecan Combined With Oxaliplatin and S-1 Versus Gemcitabine Combined With Capecitabine for Postoperative Adjuvant Treatment of Pancreatic Cancer
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 408
- 主要终点
- Disease-free survival (DFS)
研究概览
简要总结
This study will evaluate the efficacy and safety of adjuvant therapy with liposomal irinotecan in combination with oxaliplatin, and S-1 compared with capecitabine combined with capecitabine in participants with pancreatic ductal adenocarcinoma after radical surgery.
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
- •Patients able and willing to provide a written informed consent aged 18-75 years.
- •Histologically confirmed resected ductal pancreatic adenocarcinoma (including adenosquamous carcinoma).
- •Undergone radical resection and confirmed macroscopic complete resection (R0 and R1).
- •Full recovery after surgery; able to start adjuvant treatment within 12 weeks after surgery.
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-
- •The main organs function well.
排除标准
- •Patients with other types of non-ductal tumor of the pancreas, including endocrine tumors or acinar cell adenocarcinoma, pancreatoblastoma, and solid-pseudopapillary tumor.
- •Macroscopic incomplete tumor removal (R2 resection).
- •Prior neo-adjuvant treatment, radiation therapy, or systemic therapy for pancreatic adenocarcinoma.
- •Presence or history of metastatic or locally recurrent pancreatic adenocarcinoma.
- •CA 19-9> 180 U / ml within 21 days before randomization.
- •The toxicity of previous therapy has not recovered to Grade 1 or below.
- •Known peripheral neuropathy (CTCAE ≥ Grade 2).
- •Known deficiency of dihydropyrimidine dehydrogenase (DPD)
- •Subjects with a confirmed diagnosis of Gilbert's syndrome
研究组 & 干预措施
NASOX：Liposomal Irinotecan; Oxaliplatin; S-1
Liposomal irinotecan at a dose of 50 mg/m² is administered intravenously over 90 minutes on D1. Oxaliplatin is administered at a dose of 60 mg/m² intravenously over 2 hours on D1. S-1 at a dose of 40 to 60mg twice daily is taken orally for 7 consecutive days, followed by a 7-day break. These medications are administered once every 2 weeks for a total of 12 cycles.
干预措施: Liposomal Irinotecan (Drug)
NASOX：Liposomal Irinotecan; Oxaliplatin; S-1
Liposomal irinotecan at a dose of 50 mg/m² is administered intravenously over 90 minutes on D1. Oxaliplatin is administered at a dose of 60 mg/m² intravenously over 2 hours on D1. S-1 at a dose of 40 to 60mg twice daily is taken orally for 7 consecutive days, followed by a 7-day break. These medications are administered once every 2 weeks for a total of 12 cycles.
干预措施: Oxaliplatin (Drug)
NASOX：Liposomal Irinotecan; Oxaliplatin; S-1
Liposomal irinotecan at a dose of 50 mg/m² is administered intravenously over 90 minutes on D1. Oxaliplatin is administered at a dose of 60 mg/m² intravenously over 2 hours on D1. S-1 at a dose of 40 to 60mg twice daily is taken orally for 7 consecutive days, followed by a 7-day break. These medications are administered once every 2 weeks for a total of 12 cycles.
干预措施: S-1 (Drug)
GX：Gemcitabine; Capecitabine
Gemcitabine at a dose of 1000mg/m² is administered via intravenous infusion over 30 minutes on D1, 8, and 15 of a 28-day cycle. Capecitabine at a dose of 1660mg/m² per day in two divided oral doses is taken for 21 consecutive days, followed by a 7-day rest period. These medications are administered once every 4 weeks for a total of 6 cycles.
干预措施: Gemcitabine (Drug)
GX：Gemcitabine; Capecitabine
Gemcitabine at a dose of 1000mg/m² is administered via intravenous infusion over 30 minutes on D1, 8, and 15 of a 28-day cycle. Capecitabine at a dose of 1660mg/m² per day in two divided oral doses is taken for 21 consecutive days, followed by a 7-day rest period. These medications are administered once every 4 weeks for a total of 6 cycles.
干预措施: Capecitabine (Drug)
结局指标
主要结局
Disease-free survival (DFS)
时间窗: Approximately 3 years.
Disease-free survival is defined as the time from the date of randomization to the date of disease recurrence or death from any cause (whichever occurs first). Disease recurrence is defined as evidence of disease recurrence demonstrated by imaging assessment with CT or MRI scan and/or pathological diagnosis indicated by biopsy.
次要结局
- Overall survival (OS)(Approximately 5 years.)