超高剂量消融放射外科联合免疫疗法治疗大块转移性癌症患者的剂量递增研究
2024年5月14日 更新者:Gregory Gan、University of Kansas Medical Center
免疫疗法与超高剂量消融放射外科治疗相结合 (ICARUS):转移性癌症的 I 期剂量递增放射外科研究
本研究的目的是确定使用超高剂量 SBRT 联合免疫疗法对大块转移性疾病进行细胞减灭术对于已用尽 SoC 治疗方案的患者是否耐受且可行。
研究概览
详细说明
提供知情同意书的患者将接受 30 天的筛选期,以确定是否有资格参加试验。
如果符合条件,患者将开始接受 SBRT(在 1-2 周内进行超过 3-5 个分次的转移)治疗,同时接受阿特朱单抗(每个 28 天周期的第一天 1680 毫克)免疫治疗方案的辅助治疗,疗程最长为一年。
研究类型
介入性
注册 (估计的)
54
阶段
- 阶段1
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习联系方式
- 姓名:Nurse Navigator
- 电话号码:913-945-7552
- 邮箱:CTNurseNav@kumc.edu
研究联系人备份
- 姓名:Maggie Thomas
- 电话号码:913-945-9383
- 邮箱:mthomas37@kumc.edu
学习地点
-
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Kansas
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Kansas City、Kansas、美国、66160
- The University of Kansas Medical Center
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接触:
- Nurse Navigator
- 电话号码:913-945-7552
- 邮箱:CTNurseNav@kumc.edu
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参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
纳入标准:
- 参与者理解本研究的能力,以及参与者签署书面知情同意书的意愿
- 男性和女性年龄≥18岁
- 通过 RECIST 1.1 可测量的疾病 参与者必须至少有两个可通过 RECIST v1.1 标准测量的放射学可识别病变,并且其中一个病变必须≥65 cc。 注意:“cc”等于(宽 x 长 x 高)/2 以提供粗略近似值。 例如,5.1 x 5.1 x 5.1 cm 的肿瘤为 66.3 cc,适合试验入组
- 从上次全身治疗时间到研究治疗开始,参与者必须有 5 个消除半衰期或 28 天(以较长者为准)的清除期
- 有生育能力的女性在入组时(筛选时以及开始放疗或免疫治疗前 48 小时内)血清妊娠试验必须呈阴性
- 患有活检和放射学证实转移性癌症(即肺癌、头颈癌、卵巢癌、结直肠癌、肉瘤)的参与者
- 至少第一线 (1L) 全身治疗或免疫治疗必须对参与者失败,并且标准护理治疗选择也必须用尽。 由于疾病进展以外的原因而停止的标准护理选择是合格的。 注:停止全身治疗并接受监视成像监测、随后出现疾病进展并且没有标准护理治疗选择的参与者有资格参加。
- 至少一个病灶(最多四个病灶)必须≥65 cc(使用肿瘤长 x 宽 x 高最接近的近似值计算)
- 如果要治疗的病灶和周围区域(没有明显的剂量重叠,根据需要根据具体情况进行评估)之前未接受过超高剂量 SBRT 治疗,则允许事先进行 RT
- 如果在开始中枢神经系统外消融治疗之前所有病变均得到管理,则患有中枢神经系统转移性疾病的参与者将被允许参加方案
- 在进行探索性研究相关生物标志物研究的任何研究干预之前,可获得来自癌症转移诊断的代表性 (FFPE) 肿瘤样本
足够的器官功能,定义为在开始研究治疗前 14 天内获得的以下实验室测试结果:
- 白细胞≥3K/μL
- 淋巴细胞计数 ≥ 0.5 x 10^9/L (500/μL)
- 中性粒细胞绝对计数≥1.5K/μL,无粒细胞集落刺激因子支持。 注意:如果治疗医生认为试验治疗不会给参与者带来过高的感染风险,则确诊为良性中性粒细胞减少症的参与者有资格参加 1000-1500 之间的 ANC
- 血小板≥100K/μL),无需输血
- 血红蛋白≥9克/分升
- 血清肌酐 ≤ 1.5 x 正常上限 (ULN) [使用 Cockcroft-Gault 公式计算]
- 总胆红素 ≤ 1.5 x ULN 或直接胆红素 ≤ 1 x ULN。 已知患有吉尔伯特病的参与者:血清胆红素 ≤ 3 x ULN
- 血清白蛋白≥35克/升(3.5克/分升)
- 天冬氨酸转氨酶、丙氨酸转氨酶和碱性磷酸酶 ≤ 2.5 x ULN,除非存在肝转移,在这种情况下它们必须 ≤ 5 x ULN
- 对于未接受抗凝治疗的参与者:INR 或 aPTT ≤ 1.5 x ULN
- 对于接受治疗性抗凝治疗的参与者:稳定的抗凝治疗方案
- 筛选时 HIV 检测呈阴性,但以下情况除外:筛选时 HIV 检测呈阳性的参与者只要抗逆转录病毒治疗稳定、CD4 计数≥ 200/μL 且病毒载量不可检测,即可符合资格。 *** 注意:如果测试结果呈阳性,参与者可能符合资格,如果身体状况稳定且没有活动性、不受控制的疾病迹象,则将由研究者决定是否适合参加试验。 在正式入组之前,请联系方案研究 PI 进行审核。
- 筛查时丙型肝炎病毒 (HCV) 抗体检测呈阴性,或 HCV 抗体检测呈阳性,随后筛查时 HCV RNA 检测呈阴性。 HCV RNA 检测必须对 HCV 抗体检测呈阳性的参与者进行。*** 注:如果测试结果呈阳性,参与者可能符合资格,如果身体状况稳定且没有活动性、不受控制的疾病迹象,则将由研究者决定是否适合参加试验。 在正式入组之前,请联系方案研究 PI 进行审核。
- 筛查时乙型肝炎表面抗原 (HbsAg) 检测呈阴性。 筛查时总乙型肝炎核心抗体 (HbcAb) 检测呈阴性,或总 HbcAb 检测呈阳性,随后筛查时乙型肝炎病毒 (HBV) DNA 检测呈阴性。 仅对 HbsAg 检测结果为阴性且总 HbcAb 检测结果为阳性的参与者进行 HBV DNA 检测。 *** 注意:如果测试结果呈阳性,参与者可能符合资格,如果身体状况稳定且没有活动性、不受控制的疾病迹象,则将由研究者决定是否适合参加试验。 在正式入组之前,请联系方案研究 PI 进行审核。
有生育潜力的女性和有生育潜力伴侣的男性必须同意在研究参与期间和 180 天/期间实行禁欲或使用生育潜力/怀孕部分及下文中列出的避孕方式治疗完成后 6 个月。 男性必须避免在同一时期捐献精子。
- 如果女性初潮后、未达到绝经后状态(闭经连续 ≥ 12 个月且除绝经外无明确原因)且未接受绝育手术(切除卵巢、输卵管和卵巢),则被认为具有生育潜力。 /或子宫)或研究者确定的其他原因(例如,苗勒管发育不全)。 根据这个定义,输卵管结扎的女性被认为具有生育潜力。 生育潜力的定义可根据当地指南或要求进行调整。
- 每年失败率<1%的避孕方法包括双侧输卵管结扎、男性绝育、抑制排卵的激素避孕药、释放激素的宫内节育器和铜宫内节育器。
- 应根据临床试验的持续时间以及参与者偏好和惯常的生活方式来评估禁欲的可靠性。 定期禁欲(例如日历法、排卵法、症状测温法或排卵后法)和停药并不是充分的避孕方法。 如果当地指南或法规有要求,当地认可的适当避孕方法以及有关禁欲可靠性的信息将在当地知情同意书中予以描述。
排除标准:
- 同时参加任何治疗性临床试验
- 参与本研究时当前或预期使用其他抗肿瘤药物或研究药物
- 被诊断患有精神疾病或处于会限制遵守研究要求的社交情况
- 是否怀孕或哺乳
- 计划在接受研究治疗期间或最后一剂研究治疗后 180 天/6 个月内怀孕的育龄女性。 有生育能力的女性在入组时(筛查时以及放射治疗或免疫治疗开始前 48 小时内)血清妊娠检测结果必须为阴性。
- 计划在接受研究治疗期间或最后一剂研究治疗后 180 天/6 个月内生育孩子或捐献精子的育龄男性
- 在第一剂研究治疗前 2 周内存在 3 级(根据 NCI CTCAE,版本 5.0)或更高级别的病毒、细菌或真菌感染
- COVID-19:有活跃的 COVID-19 症状和/或因严重或危重的 COVID-19 症状住院的参与者
- 患有不受控制的并发疾病或感染(即活动性肺炎或感染)的参与者
- 仅患有骨转移性疾病的参与者
- 免疫抑制性疾病(即实体器官移植受者、同种异体干细胞移植)(完整列表请参阅附录 D)
- 参加临终关怀中心或认为预期寿命不足 6 个月的参与者
不受控制或未经治疗的中枢神经系统转移
- 有症状、未经治疗或进展中的中枢神经系统 (CNS) 转移
接受过中枢神经系统病变治疗的无症状参与者符合资格,前提是满足以下所有标准:
- 根据 RECIST v1.1,可测量的疾病必须存在于中枢神经系统之外
- 参与者没有颅内出血或脊髓出血病史
- 参与者在开始研究治疗前7天内未接受过立体定向放射治疗,在开始研究治疗前14天内未接受过全脑放射治疗,或在开始研究治疗前28天内未接受过神经外科切除术。
- 参与者没有持续需要皮质类固醇来治疗中枢神经系统疾病
- 如果参与者正在接受抗惊厥治疗,则剂量被认为是稳定的
- 软脑膜疾病史
- 不受控制的胸腔积液、心包积液或腹水需要反复引流手术(每月一次或更频繁)。 • 允许携带留置导管(例如 PleurX)的参与者。
- 不受控制或有症状的高钙血症(离子钙 > 1.5 mmol/L,钙 > 12 mg/dL 或校正血清钙 > ULN
- 不受控制的肿瘤相关疼痛。 需要止痛药的参与者在研究开始时必须采用稳定的治疗方案。
自身免疫性疾病或免疫缺陷的活动期或病史,包括但不限于重症肌无力、肌炎、自身免疫性肝炎、硬皮病、系统性红斑狼疮、类风湿性关节炎、炎症性肠病、抗磷脂抗体综合征、韦格纳肉芽肿病、干燥综合征、格林-巴雷综合征或多发性硬化症,但以下情况除外:
- 有自身免疫相关甲状腺功能减退病史且正在服用甲状腺替代激素的参与者有资格参加该研究
- 接受胰岛素治疗且 1 型糖尿病得到控制的参与者有资格参加该研究
患有湿疹、银屑病、慢性单纯性苔藓或仅具有皮肤病表现的白癜风的参与者(例如,患有银屑病关节炎的参与者被排除在外),只要满足以下所有条件,就有资格参加本研究:
- 皮疹必须覆盖 < 身体表面积的 10%
- 疾病在基线时得到良好控制,仅需要低效外用皮质类固醇
- 在过去 12 个月内,未出现需要补骨脂素加紫外线 A 辐射、甲氨蝶呤、类维生素A、生物制剂、口服钙调神经磷酸酶抑制剂或高效或口服皮质类固醇的基础疾病急性加重的情况
- 另请参阅附录 D 了解自身免疫性疾病和免疫缺陷的列表
- 特发性肺纤维化、机化性肺炎(例如闭塞性细支气管炎)、药物性肺炎或特发性肺炎病史,或胸部计算机断层扫描 (CT) 扫描显示活动性肺炎证据。 允许有放射野放射性肺炎病史(纤维化)
- 活动性结核病
- 开始研究治疗前 3 个月内患有严重心血管疾病(例如纽约心脏病协会 II 级或以上心脏病、心肌梗死或脑血管意外)、不稳定心律失常或不稳定心绞痛
- 在开始研究治疗前 4 周内进行过除诊断以外的主要外科手术,或预期在研究期间需要进行主要外科手术
- 开始研究治疗前 4 周内发生严重感染,包括但不限于因感染并发症、菌血症或严重肺炎住院,或任何可能影响参与者安全的活动性感染
- 在开始研究治疗前 2 周内使用治疗性口服或静脉注射抗生素进行治疗。 接受预防性抗生素(例如,预防尿路感染或慢性阻塞性肺病恶化)的参与者有资格参加该研究。
- 任何其他疾病、代谢功能障碍、体检发现或临床实验室发现禁忌使用研究药物,可能影响结果的解释,或可能使参与者面临治疗并发症的高风险
- 在开始研究治疗前 4 周内使用减毒活疫苗进行治疗,或在 atezolizumab 治疗期间或在 atezolizumab 最终剂量后 5 个月内预计需要此类疫苗
- 目前针对乙型肝炎的抗病毒治疗
- 在开始研究治疗前 28 天内接受研究性治疗
- 既往接受检查点阻断治疗
- 不允许既往有≥3级免疫治疗引起的肺炎和/或腹膜炎病史(允许1级或2级病例,但已完全康复并耐受后续免疫治疗)
- 在开始研究治疗前 4 周或药物 5 个半衰期(以较长者为准)内使用全身免疫刺激剂(包括但不限于干扰素和白细胞介素 2 [IL-2])进行治疗
在开始研究治疗前 2 周内接受全身免疫抑制药物治疗(包括但不限于皮质类固醇、环磷酰胺、硫唑嘌呤、甲氨蝶呤、沙利度胺和抗 TNF-α 药物),或预期在研究治疗期间需要全身免疫抑制药物研究治疗,但以下情况除外:
- 接受急性、低剂量全身性免疫抑制剂药物或一次性脉冲剂量全身性免疫抑制剂药物(例如,针对对比剂过敏,使用 48 小时皮质类固醇)的参与者有资格参加该研究
- 接受盐皮质激素(例如氟氢可的松)、治疗慢性阻塞性肺病(COPD)或哮喘的皮质类固醇或治疗直立性低血压或肾上腺功能不全的低剂量皮质类固醇的参与者有资格参加本研究
- 对嵌合或人源化抗体或融合蛋白有严重过敏反应史
- 已知对中国仓鼠卵巢细胞产品或阿特珠单抗制剂的任何成分过敏
- 已知对 atezolizumab 制剂的任何成分过敏或超敏反应
- 对研究药物配方中所含的任何赋形剂有已知的过敏反应
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:不适用
- 介入模型:顺序分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
实验性的:SBRT 联合阿特珠单抗免疫治疗和辅助治疗
|
Atezolizumab 将每 4 周以 1680 mg IV 途径的固定剂量给药(每个 28 天周期的第一天 1680 mg),这是阿特珠单抗的批准剂量,如处方信息中所述。
超高剂量消融放射外科 SBRT 在 1-2 周内对转移灶进行 3-5 次治疗 |
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
针对 3 个不同身体部位的超高剂量立体定向消融放射治疗 (SBRT) 的最大耐受剂量
大体时间:1个月
|
3个不同身体部位(即周围肺、纵隔-中央肺和腹部-骨盆)的超高剂量SBRT的最大耐受剂量
|
1个月
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
根据 CTCAE v4.0 的评估,评估接受超高剂量消融放射外科联合免疫治疗并出现治疗相关不良事件的参与者人数
大体时间:入组至 SBRT 治疗结束后 1 个月(约 2 个月)
|
评估超高剂量 SBRT 与同时和辅助阿替利珠单抗治疗已用尽标准护理治疗方案的癌症患者的安全性
|
入组至 SBRT 治疗结束后 1 个月(约 2 个月)
|
3 个不同身体部位对超高剂量 SBRT 的总体肿瘤反应率
大体时间:SBRT 后 3 个月和 6 个月的治疗前(约 7 个月)
|
评估接受超高剂量 SBRT 并同时使用和辅助 atezolizumab 治疗的参与者的总体肿瘤缓解率
|
SBRT 后 3 个月和 6 个月的治疗前(约 7 个月)
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接受超高剂量立体定向消融放射治疗 (SBRT) 并同时使用和辅助 atezolizumab 治疗的参与者的无进展生存期
大体时间:最长 2 年
|
旨在评估在用尽标准护理治疗方案的癌症患者中接受超高剂量 SBRT 联合阿特珠单抗辅助治疗的患者的无进展生存期。
|
最长 2 年
|
接受超高剂量立体定向消融放射治疗 (SBRT) 并同时使用和辅助 atezolizumab 治疗的参与者的总体生存率
大体时间:最长 2 年
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评估已用尽标准护理治疗方案的癌症患者接受超高剂量 SBRT 联合阿特珠单抗辅助治疗的总体生存率
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最长 2 年
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员:Gregory Gan, MD、University of Kansas Medical Center
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
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有用的网址
- Study of PD1 Blockade by Pembrolizumab With Stereotactic Body Radiotherapy in Advanced Solid Tumors
- Frebel H, Nindl V, Schuepbach RA, et al. Programmed death 1 protects from fatal circulatory failure during systemic virus infection of mice
- McClain KL, Eckstein O. Clinical features and diagnosis of hemophagocytic lymphohistiocytosis
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2024年5月23日
初级完成 (估计的)
2027年7月1日
研究完成 (估计的)
2027年7月1日
研究注册日期
首次提交
2024年5月3日
首先提交符合 QC 标准的
2024年5月14日
首次发布 (实际的)
2024年5月16日
研究记录更新
最后更新发布 (实际的)
2024年5月16日
上次提交的符合 QC 标准的更新
2024年5月14日
最后验证
2024年5月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
实体瘤的临床试验
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AstraZeneca招聘中Adv Solid Malig - H&N SCC、ATM Pro / Def NSCLC、胃癌、乳腺癌和卵巢癌西班牙, 美国, 比利时, 英国, 法国, 匈牙利, 加拿大, 大韩民国, 澳大利亚
阿替珠单抗的临床试验
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University of Southern CaliforniaNational Cancer Institute (NCI); Genentech, Inc.招聘中IVA 期肺癌 AJCC v8 | IVB 期肺癌 AJCC v8 | 肺非小细胞癌 | III 期肺癌 AJCC v8 | IV 期肺癌 AJCC v8 | II 期肺癌 AJCC v8 | IIA 期肺癌 AJCC v8 | IIB 期肺癌 AJCC v8 | IIIA 期肺癌 AJCC v8 | IIIB 期肺癌 AJCC v8 | IIIC 期肺癌 AJCC v8美国
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Corvus Pharmaceuticals, Inc.Genentech, Inc.完全的
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University Medical Center GroningenHoffmann-La Roche; Amsterdam UMC, location VUmc; Stichting Hemato-Oncologie voor Volwassenen Nederland撤销
-
Keythera Pharmaceuticals (Australia) Pty Ltd招聘中
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Celldex TherapeuticsGenentech, Inc.终止黑色素瘤 | 肿瘤 | 组织学类型的肿瘤 | 肾脏肿瘤 | 癌,肾细胞 | 泌尿系肿瘤 | 泌尿生殖系统肿瘤 | 肾脏疾病 | 泌尿系统疾病 | 头颈癌 | 膀胱癌 | 三阴性乳腺癌 | 非小细胞肺癌 | 透明细胞转移性肾细胞癌美国
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Institut BergoniéRoche Pharma AG; National Cancer Institute, France; Eikon Therapeutics招聘中黑色素瘤 | 胰腺癌 | 非小细胞肺癌 | 膀胱癌 | 三阴性乳腺癌 | 实体瘤,成人 | 病毒相关肿瘤法国
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Chonnam National University HospitalRoche Pharma AG完全的
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Spanish Oncology Genito-Urinary GroupRoche Farma, S.A; Dynamic Science S.L.主动,不招人