A Multicenter, Single-arm, Prospective Study of SBRT Combined With Zimberelimab (GLS-010) in Patients With Locally Advanced Pancreatic Cancer (SPARK-1 Study)
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 96
- 主要终点
- Overall survival (OS)
研究概览
简要总结
This trial is designed to investigate the efficacy and safety of patients with locally advanced pancreatic cancer by SBRT combined with Zimberelimab(GLS-010).
详细描述
This a prospective, single-arm, multicenter study evaluating the efficacy and safety of stereotactic radiotherapy (SBRT) and Zimberelimab(GLS-010) in patients with pancreatic cancer. The primary endpoint is OS, and the secondary are PFS, ORR,DCR and adverse events.
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
- •18-75 years old.
- •Locally advanced pancreatic cancer confirmed histologically and defined according to the NCCN Pancreatic Cancer Guidelines v1.2022 as unresectable or surgically declined.
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-
- •The expected survival ≥ 3 months.
- •At least one tumor lesion meeting measurable disease criteria as determined by RECIST v1.
- •Patient must have adequate organ function defined by the study-specified laboratory tests.
排除标准
- •Tumor invasion of the gastrointestinal tract, specifically pancreatic tumor or lymph node metastasis invading the gastrointestinal parenchyma.
- •Woman who are pregnant or breastfeeding.
- •Has a known additional malignancy within the past 5 years, except for cured skin cancer and cervical carcinoma in situ.
- •Patients who have received prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4, or with an agent directed to another stimulatory or co-inhibitory T-cell receptor.
- •Contraindications to immunotherapy.
- •Other conditions that investigator decides not suitable for the trial.
研究组 & 干预措施
SBRT Combined With Zimberelimab
Patients diagnosed with locally advanced pancreatic cancer are treated with SBRT combined with Zimberelimab
干预措施: Stereotactic body radiation(SBRT) (Radiation)
SBRT Combined With Zimberelimab
Patients diagnosed with locally advanced pancreatic cancer are treated with SBRT combined with Zimberelimab
干预措施: Zimberelimab (GLS-010) (Drug)
结局指标
主要结局
Overall survival (OS)
时间窗: 2 years
Overall survival (PFS) will be defined as the elapsed time from the first date of study treatment until death from any cause. For patients who remain alive, follow-up time will be censored at the date of last disease assessment.
次要结局
- Objective response rate (ORR)(2 years)
- Disease Control Rate (DCR)(2 years)
- Adverse Events(2 years)
- Progression-free survival (PFS)(2 years)