NCT03519308终止早期 1 期
A Pilot Study of Perioperative Nivolumab and Paricalcitol to Target the Microenvironment in Resectable Pancreatic Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 早期 1 期
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Number of Adverse Events
研究概览
简要总结
The main purpose of this study is to look at the potential effects of paricalcitol (a drug similar to vitamin D) and nivolumab on pancreatic tumors in patients who are treated with gemcitabine and abraxane. The study will also look at the safety of including paricalcitol and nivolumab as part of the gemcitabine and abraxane chemotherapeutic regimen.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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
- •Previously untreated, apparently resectable adenocarcinoma of the pancreas at registration.
- •Age greater than or equal to 18 years
- •ECOG performance status of 0-
- •Standard laboratory criteria for hematologic, biochemical, and urinary indices within a range that, in the opinion of the physician, clinically supports enrollment of the subject on the trial.
- •a. Note: subjects must have: Creatinine < 2xULN, Neutrophils >1.5x109/L, total bilirubin < 3xULN, AST <5xULN, ALT <5xULN, and Platelets >100,000/mm3
- •Ability to provide written informed consent
排除标准
- •Subjects with hypercalcemia (blood levels greater than 11.5 mg/dL). In subjects creatinine clearance <60mL/min, blood calcium levels must be 9.5 mg/dL or lower.
- •Subjects who are currently pregnant, planning to become pregnant, or breast-feeding
- •Females participants of child-bearing potential are required to use an effective contraception method (see Appendix A) or abstain from intercourse during treatment and for at least 5 months following the last dose
- •Males participants with partners of child-bearing potential are required to use an effective contraception method (see Appendix A) or abstain from intercourse during treatment and for at least 5 months following the last dose
- •Subjects who, in the opinion of the physician, would not be clinically appropriate for receipt of the therapy regimen associated with participation
- •Subjects with contraindications to immune checkpoint therapy, as follows:
- •Interstitial lung disease that is symptomatic or may interfere with the detection and management of suspected drug-related pulmonary toxicity
- •Prior organ allograft or allogeneic bone marrow transplantation
- •Pre-existing thyroid abnormality with thyroid function that cannot be maintained in the normal range with medication
- •Active autoimmune disease, except for vitiligo, type 1 diabetes mellitus, asthma, atopic dermatitis, or endocrinopathies manageable by hormone replacement; other autoimmune conditions may be allowable at the discretion of the principal investigator
- •Condition requiring systemic treatment with either corticosteroids
- •Systemic steroids at physiologic doses (equivalent to dose of oral prednisone 10 mg) are permitted. Steroids as anti-emetics for chemotherapy are strongly discouraged (see section 5.1.3)
- •Intranasal, inhaled, topical, intra-articular, and ocular corticosteroids with minimal systemic absorption are permitted
研究组 & 干预措施
Arm A
Experimental
干预措施: Gemcitabine (Drug)
Arm A
Experimental
干预措施: Nivolumab (Drug)
Arm A
Experimental
干预措施: Nab-Paclitaxel (Drug)
Arm A
Experimental
干预措施: Paricalcitol (Drug)
Arm B
Experimental
干预措施: Nivolumab (Drug)
Arm B
Experimental
干预措施: Nab-Paclitaxel (Drug)
Arm B
Experimental
干预措施: Gemcitabine (Drug)
结局指标
主要结局
Number of Adverse Events
时间窗: 18 months
An adverse event (AE) was defined as any unfavorable symptom, sign, illness or experience that occurs at any dose and develops or worsens in severity during the course of the study. AEs were graded using the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.
次要结局
- Overall Survival(1 year)
- Objective Response Rate(3 months)
- Progression-free Survival(1 year)
- Proportion of Patients Undergoing Surgery(3 months)
- Proportion of Margin Negative Surgical Resections(3 months)
研究者
研究点 (1)
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