NCT04819516招募中1 期
A Single-arm, Single-center Exploratory Study of the Safety and Effectiveness of High-intensity Focused Ultrasound Therapy Combined With REGOTORI for Metastatic Colorectal Cancer
Second Affiliated Hospital, School of Medicine, Zhejiang University1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2020年12月7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
- 10
- 试验地点
- 1
- 主要终点
- Number of Participants With Abnormal Laboratory Values
研究概览
简要总结
This study intends to perform high-intensity focused ultrasound combined with REGOTORI in patients with multiline drug-resistant metastatic colorectal cancer to explore the safety and efficacy of patients. Patients receive HIFU local treatment combined with REGOTORI treatment, and receive corresponding clinical data collection at different follow-up points, including necessary data from various laboratories, CT/MRI, and immune function tests that are exactly the same as before surgery collection.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The subject has metastatic colorectal cancer, and the first and second-line standard treatments have failed
- •There is at least one target lesion that can be treated with HIFU
- •Voluntarily accept this treatment clinical research, and sign the "Subject Informed Consent"
- •18-75 years old, no gender limit
- •The level of physical strength of the Eastern Cooperative Oncology Group (ECOG): PS<=2
- •The expected survival time is greater than 3 months
- •No chemotherapy or radiotherapy within 21 days before enrollment
- •The function of major organs is basically normal
排除标准
- •Pregnant or lactating women
- •People infected with HIV, hepatitis C virus and Treponema pallidum
- •There is an active infection that requires systemic treatment (such as active tuberculosis)
- •Severe infection within 4 weeks before starting the study treatment
- •Subjects who have received allogeneic tissue/solid organ transplantation
- •The patient suffers from major vascular disease or irregular bleeding disease
- •Suffer from physiological or pathological malnutrition diseases, chronic diarrhea, cachexia, etc.
- •The patient has autoimmune diseases, such as (but not limited to) multiple sclerosis, systemic lupus erythematosus and inflammatory bowel disease, vitiligo
- •The patient has a history of serious drug or food allergy (for example, allergy to protein)
- •The patient has serious heart disease (including but not limited to: myocardial infarction, cardiomyopathy, valvular disease, malignant arrhythmia, etc.), severe liver and kidney damage, uncontrolled blood sugar and blood pressure (the subject's blood pressure, After using antihypertensive drugs, it still cannot be controlled within the normal range; fasting blood glucose is still >10mmol/L after using antihypertensive drugs)
- •The patient has uncontrollable seizures or loss of insight due to mental illness
- •In the 12 months before screening, the patient has a history of drug abuse, drug abuse, and long-term alcoholism
- •Within 3 months before screening, the patient is participating in other clinical studies
- •Other situations that cannot participate in clinical research.
研究组 & 干预措施
HIFU with REGOTORI
Experimental
干预措施: high-intensity focused ultrasound therapy (Procedure)
HIFU with REGOTORI
Experimental
干预措施: Toripalimab (Drug)
结局指标
主要结局
Number of Participants With Abnormal Laboratory Values
时间窗: 12 months from baseline
Adverse events
时间窗: 12 months from baseline
次要结局
- Numeric rating scale(12 months from baseline)
- Number of Participants With Abnormal Tumor markers(9 months from baseline)
- Disease Control Rate(From Baseline to primary completion date, about 60 months)
- Progression Free Survival(From Baseline to primary completion date, about 60 months)
- QoL(12 months from baseline)
研究者
Ying Yuan, MD
Professor, Department of Medical Oncology
Second Affiliated Hospital, School of Medicine, Zhejiang University
研究点 (1)
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