jRCT2031240644尚未招募不适用
A Phase I Study of Natural MicroRNA Replacement Therapy for Cervical Lymph Node Recurrent Lesions in Head and Neck Cancer Patients
PURMX Therapeutics, Inc.0 个研究点目标入组 7 人开始时间: 待定最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 7
- 主要终点
- Adverse events
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Single Arm Study
- 干预模型
- Single Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
入选标准
- •All of the following criteria must be met in order to participate in this study
- •(1) Patients with cytology or histology confirmed head and neck cancer with primary site in the oral cavity, hypopharynx, mid-pharynx, or larynx
- •(2) Patients with recurrence in cervical lymph nodes after radical resection of the primary lesion
- •(3) Patients with resectable cervical lymph node lesions (Total volume of recurrent cervical lymph node lesions by CT or MRI scan prior to study intervention must be less than 450 cm 3) of at least 15 mm in short diameter
- •(4) Patients with no recurrent lesions other than cervical lymph nodes on CT, MRI or PET scan prior to study intervention
- •(5) Patients who have given written informed consent to participate in this study and have given their free written consent
- •(6) Patients (of any gender) ages 18 years and older
- •(7) Patients with ECOG Performance Status of 0 or 1
- •(8) Patients with adequate bone marrow, kidney, and liver function:
- •White blood cell (WBC) >= 3,000/ micro L
- •Absolute neutrophil count (ANC) >= 1,500/ micro L
- •Platelet count >= 100,000/ micro L
- •Hemoglobin >= 9.0 g/dL
- •Creatinine within normal range
- •AST <= 3.0 x ULN
- •ALT <= 3.0 x ULN
- •Alkaline phosphatase (ALP) <= 2.5 x ULN
- •Total bilirubin <=1.5 x ULN
- •(9) All female patients of childbearing potential must have a negative serum pregnancy test prior to the start of the study intervention. Patients of childbearing potential must agree to use effective contraception during the study intervention
排除标准
- •Persons who meet any of the following criteria are not eligible for this study
- •(1) Patients who received other study interventions within 4 weeks prior to the start of the study intervention
- •(2) Patients who received chemotherapy within 4 weeks prior to study intervention
- •(3) Patients who received radiation therapy within 4 weeks prior to the start of the study intervention
- •(4) Patients who received immune checkpoint inhibitors within 12 weeks prior to study intervention
- •(5) Patients expected to have difficulty with intra-tumor administration of MIRX002
- •(6) Patients with a history of allergy to general or local anesthesia
- •(7) Patients with serious heart disease
- •(8) Patients with severe or difficult-to-control systemic diseases (e.g., diabetes mellitus, hypertension, etc.) as judged by the investigator, etc.
- •(9) Patients with active infections (requiring systemic administration of antibiotics, antifungals, antivirals, etc.)
- •(10) Patients receiving systemic administration of steroids or immunosuppressive agents
- •(11) Patients with active overlapping cancers (simultaneous overlapping cancers or iatrogenic overlapping cancers with a disease-free interval of 2 years or less)
- •(12) Patients with brain metastases that are symptomatic or require treatment
- •(13) Patients with pericardial effusions requiring treatment
- •(14) Patients scheduled to receive other anticancer therapy during the study period
- •(15) Patients who have received organ transplants in the past
- •(16) Patients with psychosis or psychotic symptoms who are unable to participate in the study
- •(17) Pregnant patients, lactating patients (incorporation due to interruption of lactation is also not allowed), patients who may be pregnant or intend to become pregnant
- •(18) Patients deemed ineligible for the study by the investigator or others for any other reason
结局指标
主要结局
Adverse events
Adverse events based on the National Cancer Institute's Common Terminology Criteria for Adverse Events v5.0
Incidence of DLT
Incidence of DLT as defined in the study protocol
General condition
General condition (body weight, ECOG-PS) vital signs
Laboratory test results
Laboratory test results (hematology, blood biochemistry, coagulation tests, urinalysis, 12-lead EKG)
次要结局
- Objective tumor shrinkage effect
- Pathologic Response Effect in Lymph Node Lesions
- Completion rate of salvage surgery
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