Stereotactic Body Radiotherapy Followed by Ipilimumab N01 Plus Sintilimab in Combination With Nab-Paclitaxel and Gemcitabine for the Treatment of Locally Advanced Pancreatic Cancer: A Phase II, Prospective, Single-Arm Exploratory Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 47
- 试验地点
- 1
- 主要终点
- Progression-Free Survival (PFS)
研究概览
简要总结
This is a Phase II, prospective, single-arm exploratory clinical trial designed to evaluate the efficacy and safety of stereotactic body radiotherapy followed by ipilimumab N01 plus sintilimab in combination with nab-paclitaxel and gemcitabine in patients with locally advanced pancreatic cancer. Eligible patients will receive SBRT followed by sequential systemic therapy. The primary endpoint is progression-free survival, and secondary endpoints include overall survival, disease control rate, duration of response, objective response rate, and safety.
详细描述
This study is a Phase II, prospective, single-arm exploratory clinical trial in patients with locally advanced pancreatic cancer. The study aims to explore the efficacy and safety of stereotactic body radiotherapy followed by ipilimumab N01 plus sintilimab in combination with nab-paclitaxel and gemcitabine.
Eligible patients will first receive stereotactic body radiotherapy at a dose of 5-10 Gy for 5 fractions. One week after completion of SBRT, patients will receive sequential systemic therapy consisting of ipilimumab N01, sintilimab, nab-paclitaxel, and gemcitabine. Ipilimumab N01 will be administered at 1 mg/kg intravenously every 6 weeks for a total of 4 doses. Sintilimab will be administered at 200 mg intravenously every 3 weeks. Nab-paclitaxel will be administered at 125 mg/m² on Days 1 and 8, and gemcitabine will be administered at 1000 mg/m² on Days 1 and 8 of each 3-week cycle. Nab-paclitaxel and gemcitabine will be given for 6 to 8 cycles, and sintilimab may be continued as maintenance treatment until disease progression, unacceptable toxicity, withdrawal of consent, initiation of new anti-cancer therapy, death, or other protocol-specified reasons.
Tumor assessments will be performed regularly according to RECIST 1.1. The primary endpoint is progression-free survival. Secondary endpoints include overall survival, disease control rate, duration of response, objective response rate, and safety. Adverse events will be monitored throughout the study and graded according to applicable safety criteria.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Participants voluntarily agree to participate in the study, sign the informed consent form, and are willing and able to comply with study procedures and follow-up.
- •Histologically or cytologically confirmed pancreatic ductal adenocarcinoma.
- •Locally advanced unresectable pancreatic cancer without distant metastasis, confirmed by multidisciplinary team evaluation.
- •Age 18 to 75 years, inclusive.
- •Eastern Cooperative Oncology Group performance status of 0 to
- •Life expectancy of at least 3 months.
- •No prior systemic therapy for advanced pancreatic cancer.
- •At least one measurable lesion according to RECIST 1.1.
排除标准
- •Participation in another anti-cancer drug clinical trial within 4 weeks before enrollment.
- •Prior targeted therapy or prior treatment with immune checkpoint inhibitors.
- •Presence of distant organ metastasis, including liver, peritoneal, brain, or meningeal metastasis.
- •Pregnancy or breastfeeding.
- •Any condition that, in the investigator's opinion, makes the participant unsuitable for enrollment in this study.
结局指标
主要结局
Progression-Free Survival (PFS)
时间窗: From initiation of study treatment until disease progression or death, assessed up to 36 months
Progression-free survival is defined as the time from the initiation of study treatment to the first documented disease progression according to RECIST 1.1 or death from any cause, whichever occurs first.
次要结局
- Overall Survival (OS)(From initiation of study treatment until death from any cause, assessed up to 36 months)
- Disease Control Rate (DCR)(From initiation of study treatment until disease progression or death, assessed up to 36 months)
- Duration of Response (DoR)(From first documented response until disease progression or death, assessed up to 36 months)
- Objective Response Rate (ORR)(From initiation of study treatment until disease progression or death, assessed up to 36 months)
- Incidence and Severity of Adverse Events(From initiation of study treatment until 30 days after the last dose of study treatment)
研究者
Jinbo Yue
Director of Radiation Oncology Department
Shandong Cancer Hospital and Institute