NCT05604560进行中（未招募）2 期
A Neoadjuvant Study of Tislelizumab and SX-682 for Resectable Pancreas Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- Lei Zheng
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Change in Immune response rate as assessed by density of intratumoral granzyme B+ CD137+ T cells
研究概览
简要总结
The purpose of this study is to evaluate the safety and clinical activity of tislelizumab (an anti-PD-1 antibody) in combination with SX-682 (a CXCR1/2 inhibitor) in subjects with newly diagnosed and surgically resectable pancreatic adenocarcinoma.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ability to understand and willingness to sign a written informed consent document.
- •Age ≥18 years.
- •Newly diagnosed have histologically or cytologically proven adenocarcinoma of the pancreas.
- •Tumor must be resectable.
- •Patient's acceptance to have a tumor biopsy.
- •ECOG performance status 0 or 1
- •Patients must have adequate organ and marrow function defined by study-specified laboratory tests.
- •For both Women and Men, must use acceptable form of birth control while on study.
排除标准
- •Have received any anti-pancreatic cancer therapy.
- •Have been diagnosed with another malignancy whose natural history or treatment has the potential to interfere with safety or efficacy assessment of this study.
- •Conditions, including alcohol or drug dependence, intercurrent illness, or lack of sufficient peripheral venous access, that would affect the patient's ability to comply with study visits and procedures
- •Subjects with active, known or suspected autoimmune disease that may relapse.
- •Systemic steroid therapy (> 10mg daily prednisone equivalent) or immunosuppressive therapy within 14 days of first dose of study drug administration.
- •Active infection requiring systemic therapy.
- •Infection with HIV or hepatitis B or C at screening•
- •History of interstitial lung disease, non-infectious pneumonitis or uncontrolled diseases including pulmonary fibrosis, acute lung diseases, etc.
- •Uncontrolled intercurrent illness including, but not limited to, uncontrolled infection, pulmonary embolism, uncontrolled hypertension, symptomatic congestive heart failure, unstable angina, cardiac arrhythmia, metastatic cancer, or psychiatric illness/social situations that would limit compliance with study requirements.
- •Prior allogeneic stem cell transplantation or organ transplantation
- •Any major surgical procedure requiring general anesthesia ≤ 28 days before first dose of study drug.
- •Have received a live vaccine ≤ 28 days before first dose of study drug.
- •Use of QT prolonging drugs within 2 weeks before the start of SX-682 dosing and for the length of the study.
- •ECG demonstrating a QTc interval ≥ 470 msec or patients with congenital long QT syndrome.
- •Severe hypersensitivity reaction to any monoclonal antibody.
- •Concurrent participation in another therapeutic clinical study
- •Pregnant or breastfeeding
研究组 & 干预措施
Arm A - Tislelizumab and SX-682
Experimental
干预措施: Tislelizumab (Drug)
Arm A - Tislelizumab and SX-682
Experimental
干预措施: SX-682 (Drug)
结局指标
主要结局
Change in Immune response rate as assessed by density of intratumoral granzyme B+ CD137+ T cells
时间窗: Baseline and 2 weeks
The change in density of intratumoral granzyme B+ CD137+ T cells before and after neoadjuvant treatment with tislelizumab and SX-682.
Pathologic Response Rate as assessed by number of patients with a grade 0-2 pathologic response
时间窗: 4 years
The number of patients with a grade 0-2 pathologic response as defined by the College of American Pathologists (CAP) tumor regression grading system.
次要结局
- Overall Survival (OS)(4 years)
- Number of participants experiencing grade 3 or above drug-related toxicities(4 years)
- Disease Free Survival (DFS)(4 years)
研究者
Lei Zheng
Executive Director of University of Texas Health Science Center at San Antonio Cancer Center
The University of Texas Health Science Center at San Antonio
研究点 (2)
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