A Phase II Study on the Safety and Efficacy of PD-1 Combined With Nab-paclitaxel/Gemcitabine and PULSAR in the Treatment of Locally Advanced Unresectable Pancreatic Cancer and Local Recurrence After Surgery.
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 81
- 试验地点
- 1
- 主要终点
- Progression-free survival (PFS)
研究概览
简要总结
This trial is a phase II clinical trial of the safety and efficacy of PD-1 antibody (Toripalimab) in combination with paclitaxel (albumin-bound type) and gemcitabine and PULSAR radiotherapy in patients with locally advanced unresectable pancreatic cancer and patients with only local recurrence after pancreatic cancer surgery, to observe the safety and efficacy of PD-1 antibody (Toripalimab) in combination with paclitaxel (albumin-bound type) and gemcitabine and PULSAR in the treatment of patients with locally advanced unresectable pancreatic cancer.
详细描述
This trial is a phase II clinical trial of the safety and efficacy of PD-1 antibody (Toripalimab) in combination with paclitaxel (albumin-bound type) and gemcitabine and PULSAR radiotherapy in patients with locally advanced unresectable pancreatic cancer and patients with only local recurrence after pancreatic cancer surgery, to observe the safety and efficacy of PD-1 antibody (Toripalimab) in combination with paclitaxel (albumin-bound type) and gemcitabine and PULSAR in the treatment of patients with locally advanced unresectable pancreatic cancer.
Progression-free survival (PFS), objective response rate (ORR), overall survival (OS), surgical conversion rate, and quality of life were observed in subjects with locally advanced unresectable pancreatic cancer with precise histological or cytological diagnosis and patients with only local recurrence after surgery. This is a single-center study. A total of 46 subjects with locally advanced unresectable pancreatic cancer and 35 subjects with locally recurrent pancreatic cancer after surgery were planned to be enrolled.
The estimated enrollment time is 18 months, with at least 18 months of follow-up for each subject.
This trial will evaluate the safety data of all subjects who have received at least one dose of study treatment for analysis. The National Cancer Institute (NCI) Common Adverse Event Evaluation Criteria (CTCAE version 5.0) were used. The efficacy evaluation was done according to the clinical diagnosis and treatment routine-follow-up patients combined with follow-up records.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
PD-1 Combined With chemotherapy + PULSAR.
Toripalimab: 240 mg/time, intravenously infused over 30 minutes， administered once every three weeks until the treatment termination event specified in the protocol occurs.
Paclitaxel for injection (albumin-bound): 125 mg/m2 and infuse intravenously for at least 30 minutes: D1, 8 days of administration. Every 21 days is a cycle.
Gemcitabine hydrochloride for injection: 1000 mg/m2 for intravenous infusion over 30 minutes: D1, 8 days of administration. Every 21 days is a cycle.
PULSAR: Hypofractionated or stereotactic radiotherapy for the primary pancreatic tumor lesions and surrounding metastatic lymph nodes, 5-10 Gy/time, in conjunction with the chemotherapy cycle, completed once within each chemotherapy cycle, for a total of 5 times.
干预措施: PD-1 (Drug)
PD-1 Combined With chemotherapy + PULSAR.
Toripalimab: 240 mg/time, intravenously infused over 30 minutes， administered once every three weeks until the treatment termination event specified in the protocol occurs.
Paclitaxel for injection (albumin-bound): 125 mg/m2 and infuse intravenously for at least 30 minutes: D1, 8 days of administration. Every 21 days is a cycle.
Gemcitabine hydrochloride for injection: 1000 mg/m2 for intravenous infusion over 30 minutes: D1, 8 days of administration. Every 21 days is a cycle.
PULSAR: Hypofractionated or stereotactic radiotherapy for the primary pancreatic tumor lesions and surrounding metastatic lymph nodes, 5-10 Gy/time, in conjunction with the chemotherapy cycle, completed once within each chemotherapy cycle, for a total of 5 times.
干预措施: Nab-paclitaxel (Drug)
PD-1 Combined With chemotherapy + PULSAR.
Toripalimab: 240 mg/time, intravenously infused over 30 minutes， administered once every three weeks until the treatment termination event specified in the protocol occurs.
Paclitaxel for injection (albumin-bound): 125 mg/m2 and infuse intravenously for at least 30 minutes: D1, 8 days of administration. Every 21 days is a cycle.
Gemcitabine hydrochloride for injection: 1000 mg/m2 for intravenous infusion over 30 minutes: D1, 8 days of administration. Every 21 days is a cycle.
PULSAR: Hypofractionated or stereotactic radiotherapy for the primary pancreatic tumor lesions and surrounding metastatic lymph nodes, 5-10 Gy/time, in conjunction with the chemotherapy cycle, completed once within each chemotherapy cycle, for a total of 5 times.
干预措施: Gemcitabine (Drug)
PD-1 Combined With chemotherapy + PULSAR.
Toripalimab: 240 mg/time, intravenously infused over 30 minutes， administered once every three weeks until the treatment termination event specified in the protocol occurs.
Paclitaxel for injection (albumin-bound): 125 mg/m2 and infuse intravenously for at least 30 minutes: D1, 8 days of administration. Every 21 days is a cycle.
Gemcitabine hydrochloride for injection: 1000 mg/m2 for intravenous infusion over 30 minutes: D1, 8 days of administration. Every 21 days is a cycle.
PULSAR: Hypofractionated or stereotactic radiotherapy for the primary pancreatic tumor lesions and surrounding metastatic lymph nodes, 5-10 Gy/time, in conjunction with the chemotherapy cycle, completed once within each chemotherapy cycle, for a total of 5 times.
干预措施: PULSAR (Radiation)
结局指标
主要结局
Progression-free survival (PFS)
时间窗: up to approximately 1 years
PFS is defined as the time from randomization until the date of first occurrence of investigator-assessed radiological disease progression or death due to any cause, whichever came first.
次要结局
- Overall survival (OS)(up to approximately 1 years)
- Objective response rate (ORR)(up to approximately 1 years)
- Surgical Conversion Rate(18 weeks)