NCT06278454招募中1 期
A Phase I Study to Evaluate the Safety, Tolerance and Efficacy of NRT6008 Injection in Unresectable Locally Advanced Pancreatic Cancer (LAPC) and Advanced Pancreatic Cancer With Lymph Node Metastases
Chengdu New Radiomedicine Technology Co. LTD.6 个研究点 分布在 1 个国家目标入组 58 人开始时间: 2024年1月9日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 58
- 试验地点
- 6
- 主要终点
- Maximum tolerated dose (MTD) or the recommended phase Ⅱ dose (RP2D)
研究概览
简要总结
This is a single arm, open label, multi-center phase I study, including phase Ia dose escalation and phase Ib dose expansion. Safety review committee (SRC) will be formed to monitor safety and efficacy data through the study. And the independent review committee (IRC) will be formed to monitor efficacy data through the study.
详细描述
The efficacy and safety of Yttrium-90 carbon microspheres in patients with unresectable LAPC or advanced pancreatic cancer with lymph node metastases remain unknown. This trial is a prospective, multicenter, open-label, single-arm phase I trial designed to evaluate the safety and efficacy of NRT6008 injection. The primary objective is to evaluate the safety of NRT6008 Injection. While the secondary objectives include the assessments of the preliminary efficacy. In addition, the distribution of NRT6008 injection in human body, and the changes of tumor biomarkers and the improvement of cancer pain status of participants after administration will also be evaluated.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged ≥18 years and ≤80 years, able to comprehend and sign an informed consent form;
- •Diagnosed with pancreatic adenocarcinoma confirmed histologically or cytologically;
- •Evaluated as unresectable LAPC or metastatic pancreatic cancer with lymph node metastasis only, as determined by the investigator; or having contraindications to surgery, or refusing surgical resection;
- •ECOG performance status score ≤1;
- •Expected survival ≥3 months;
- •According to RECIST v1.1 criteria, there is only one measurable lesion in the pancreas confirmed by imaging, and the lesion has the shortest axis diameter ≥2.0 cm, the longest axis diameter ≤6.0 cm (based on baseline imaging);
- •Adequate normal organ and marrow function as defined below: (1) Renal function: serum creatinine ≤1.5×ULN, or creatinine clearance ≥60 mL/min (calculated by the Cockcroft-Gault formula); (2) Liver function: aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≤3×ULN; serum total bilirubin ≤1.5×ULN; (3) Bone marrow function [[no blood transfusion or granulocyte colony-stimulating factor (G-CSF), human thrombopoietin (TPO), or TPO receptor agonist treatment within 14 days prior to signing informed consent]: neutrophils ≥1.5×10^9/L, hemoglobin ≥90 g/L, platelets ≥100×10^9/L; (4) Coagulation function: International normalized ratio (INR) or prothrombin time (PT) ≤1.5×ULN, and activated partial thromboplastin time (APTT) ≤1.5×ULN;
- •Female and male participants of reproductive age must voluntarily agree to practice strict and effective contraception after signing the informed consent form, during the study period, and within 12 months after administration of the investigational drug. Males are prohibited from donating sperm during this period. Female participants of reproductive age must have a negative pregnancy test result during the screening period and within 24 hours before administration of the investigational drug.
排除标准
- •Allergic to the investigational drug NRT6008 injection itself or any of its components;
- •Contraindications to any of the three optional systemic chemotherapy regimens in this study judged by investigators;
- •Previous anti-tumor treatments for pancreatic cancer, including but not limited to chemotherapy, radiotherapy, targeted therapy, immunotherapy, etc. Except for discontinuation of traditional chinese medicine or herbal medicine for at least 7 days prior to the screening period;
- •Contraindications to anesthesia;
- •History of any other malignant tumors within 5 years before receiving investigational drug treatment, except for cases of cured non-melanoma skin cancer, cervical carcinoma in situ, or basal cell carcinoma of the skin, Stage I Grade 1 endometrial carcinoma, or thyroid cancer;
- •Presence or suspected presence of distant metastases according to imaging;
- •Pregnant or lactating females;
- •Participants assessed by the investigators to be at high risk or had difficulty in operation for EUS-FNI procedures;
- •Evidence of radiographic invasion into stomach, duodenum or peritoneum;
- •Participants with chronic diseases that are actively treated but not well controlled, such as primary hypertension, diabetes, etc.;
- •Within 6 months prior to the the first administration of chemotherapy, occurrence of acute pancreatitis, severe gastrointestinal bleeding, severe cardiovascular diseases (including but not limited to stroke, unstable angina), or occurrence of acute infections requiring systemic treatment within 2 weeks before the screening period;
- •Participated in other interventional clinical trials within 1 month prior to the first administration of chemotherapy;
- •Positive for human immunodeficiency virus (HIV) antibodies;
- •Positive for hepatitis B virus (HBV) surface antigen (HBsAg) and/or hepatitis B core antibody (HBcAb), HBV DNA testing required, participants with HBV-DNA levels below the lower limit of the reference range or < 500 IU/mL will be eligible for inclusion in this study (use of antiviral drugs during the study period is required);
- •Positive for hepatitis C virus (HCV) antibodies, HCV RNA testing required, participants with negative HCV RNA results will be eligible for inclusion in this study;
- •Participants with syphilis infection or active tuberculosis;
- •Other reasons deemed unsuitable for participation in this trial by the investigators.
研究组 & 干预措施
NRT6008 Injection
Experimental
In this study, participants shall receive NRT6008 injection in combination with chemotherapy.
干预措施: NRT6008 Injection + Systematic chemotherapy (Drug)
结局指标
主要结局
Maximum tolerated dose (MTD) or the recommended phase Ⅱ dose (RP2D)
时间窗: 28 days after NRT6008 administration
Optimal dose for NRT6008 injection
Dose-limiting toxicity (DLT)
时间窗: 28 days after NRT6008 administration
Incidence rate of DLT
Adverse events (AE) and severe adverse events (SAE)
时间窗: Up to 52 weeks
Incidence rate and severity of AE and SAE
次要结局
- Overall survival (OS)(Up to 52 weeks)
- Duration of response (DOR)(Up to 52 weeks)
- Resection rate (R0 and R1)(Up to 52 weeks)
- Objective response rate (ORR)(Up to 52 weeks)
- Progression-free survival (PFS)(Up to 52 weeks)
研究者
研究点 (6)
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