NCT04484909进行中（未招募）1 期
Phase I Study of NBTXR3 Activated by Radiotherapy for Locally Advanced or Borderline Resectable Pancreatic Ductal Adenocarcinoma
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Dose-limiting toxicities
研究概览
简要总结
To find the recommended dose of NBTXR3 that can be given in combination with radiation therapy to patients with pancreatic cancer. To learn if the dose NBTXR3 found in Part 1 can help to control the disease.
详细描述
PRIMARY OBJECTIVE:
• To determine the recommended phase II dose (RP2D) of NBTXR3 activated by radiotherapy in subjects with locally advanced or borderline-resectable pancreatic ductal adenocarcinoma.
SECONDARY OBJECTIVES:
- To evaluate the safety and feasibility of NBTXR3 intratumoral injection activated by radiotherapy in locally advanced or borderline-resectable pancreatic ductal adenocarcinoma
- To evaluate the anti-tumor response of NBTXR3 intratumoral injection activated by radiotherapy in subjects with locally advanced or borderline-resectable pancreatic ductal adenocarcinoma
- To evaluate time-to-event outcomes in subjects with locally advanced or borderline-resectable pancreatic ductal adenocarcinoma
EXPLORATORY OBJECTIVES:
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
- •1. Signed informed consent form (ICF) indicating that participant understands the purpose of, and procedures required for, the study and is willing to participate in the study
- •Age ≥ 18 years
- •Biopsy proven ductal adenocarcinoma of the pancreas,as defined by the following:
- •a. Borderline resectable pancreatic adenocarcinoma (BRPC) has no aortic involvement with at least ONE of the following features: i. Superior mesenteric vein (SMV) or Portal vein (PV) with a tumor interface of ≥ 180° OR short segment occlusion of SMV or PV amenable to reconstruction ii. Superior mesenteric artery (SMA) or celiac axis (CA) with a tumor interface of < 180° iii. Any degree of hepatic artery interface that is amenable to reconstruction b. Locally advanced pancreatic adenocarcinoma (LAPC) has at least ONE of the following features:
- •Signed informed consent form (ICF) indicating that participant understands the purpose of, and procedures required for, the study and is willing to participate in the study
- •Age ≥ 18 years
- •Biopsy proven ductal adenocarcinoma of the pancreas,as defined by the following:
- •a. Borderline resectable pancreatic adenocarcinoma (BRPC) has no aortic involvement with at least ONE of the following features: i. Superior mesenteric vein (SMV) or Portal vein (PV) with a tumor interface of ≥ 180° OR short segment occlusion of SMV or PV amenable to reconstruction ii. Superior mesenteric artery (SMA) or celiac axis (CA) with a tumor interface of < 180° iii. Any degree of hepatic artery interface that is amenable to reconstruction b. Locally advanced pancreatic adenocarcinoma (LAPC) has at least ONE of the following features: i. Occlusion of the SMV or PV that is not amenable to reconstruction ii. Tumor interface of the superior mesenteric artery or celiac axis ≥ 180° iii. Involvement of the hepatic artery that is not amenable to reconstruction iv. Involvement of the aorta
- •Has had a 4-month course (± 2-months) of chemotherapy for PDAC without radiographic evidence of distant metastatic disease. Following chemotherapy regimens are allowed:
- •gemcitabine/nab-paclitaxel
- •gemcitabine/capecitabine
- •gemcitabine/cisplatin
- •gemcitabine
- •Amenable to undergo the endoscopic ultrasound guided injection of NBTXR3 as per investigator or treating physician.
- •Has a target lesion in the pancreas that is identifiable on cross sectional imaging by repeated measurements (via RECIST 1.1) at the same anatomical location
- •a. Nodal disease only is not allowed.
- •Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
- •Laboratory Values at screening:
- •Hemoglobin ≥ 8.0 g/dL
- •Absolute Neutrophil Count (ANC) ≥ 1,500/mm3
- •Platelet Count ≥ 100,000/mm3
- •Creatinine ≤ 1.5 x upper limit of normal (ULN)
- •Total Bilirubin ≤ 2.0 mg/dL
- •AST / ALT ≤ 3.0 x upper limit of normal (ULN)
- •Serum albumin ≥ 3.0 g/dL
- •Negative pregnancy test ≤ 7 days prior to NBTXR3 injection in all females of child-bearing potential
- •If participant has a history of prior duodenal or biliar plastic stent, it should be replaced with a metal stent ≥ 1 week prior to Study Day 1.
排除标准
- •Prior radiation therapy to the upper abdomen
- •Prior surgical resection of pancreatic tumor
- •Diagnosis other than pancreatic ductal adenocarcinoma. All other histologic types (i.e., adenosquamous, cystadenocarcinoma, etc.) are not eligible to participate on this study.
- •LAPC or BRPC with radiographic evidence of distant metastasis at screening.
- •Has received any approved or investigational anti-neoplastic agent other than the chemotherapies specified in this protocol (i.e. chemotherapies included in Inclusion #4)
- •Known uncontrolled (Grade ≥ 2) or active gastric or duodenal ulcer disease within 30 days of enrollment
- •Known contraindication to iodine-based or gadolinium-based IV contrast
- •Active malignancy, in addition to pancreatic cancer, with the exception of basal cell carcinoma of the skin definitively treated and relapse free within at least 1 year from diagnosis
- •Clinically significant cardiac arrhythmias (e.g., ventricular tachycardia, ventricular fibrillation, torsades de pointes, second or third degree atrioventricular heart block without a permanent pacemaker in place)
- •Class III or IV Congestive Heart Failure as defined by the New York Heart Association functional classification system <6 months prior to screening
- •Known active, uncontrolled (high viral load) HIV or hepatitis B or hepatitis C infection
- •a. Patients who have been vaccinated for hepatitis B and do not have a history of infection are eligible.
- •Female patients who are pregnant or breastfeeding
- •Women of child-bearing potential and their male partners who are unwilling or unable to use an acceptable method of birth control for the entire study period. Acceptable methods of contraception are those that, alone or in combination, result in a failure rate of < 1% per year when used consistently and correctly
- •Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (e.g., compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments
研究组 & 干预措施
Treatment (NBTXR3, radiation therapy)
Experimental
Patients receive NBTXR3 IT on day 1. Patients then undergo 15 fractions of radiation therapy between days 15-43 in the absence of disease progression or unacceptable toxicity.
干预措施: Radiation Therapy (Radiation)
Treatment (NBTXR3, radiation therapy)
Experimental
Patients receive NBTXR3 IT on day 1. Patients then undergo 15 fractions of radiation therapy between days 15-43 in the absence of disease progression or unacceptable toxicity.
干预措施: Hafnium Oxide-containing Nanoparticles NBTXR3 (Other)
结局指标
主要结局
Dose-limiting toxicities
时间窗: 4 weeks after last radiation dose
Any grade \>= 3 adverse event related to NBTXR3 and/or radiation therapy. Any toxicity (grade \>= 3) that is at least possibly related to study drug (NBTXR3) is a DLT. Adverse events will be scored based on National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE v 5.0).
Recommended phase II dose (RP2D)
时间窗: Up to 1 year
Maximum tolerated dose (MTD)
时间窗: Up to 1 year
MTD will be determined as the dose for which the isotonic estimate of the toxicity rate is closest to the target toxicity rate 30%.
次要结局
- Progression free survival (PFS)(From NBTXR3 injection to local recurrence, local progression, distant progression, or death from any cause, whichever occurs first, assessed up to 1 year)
- Determination of the feasibility of NBTXR3 injection in pancreas(Up to 1 year)
- Overall survival (OS)(From NBTXR3 injection to death from any cause or EoS, whichever occurs first, assessed up to 1 year)
研究者
研究点 (2)
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