ACTRN12619001078145终止2 期
Treatment of Patients with Advanced Cancer by Targeting Cancer Stem Cells Using Modulators of the Renin-Angiotensin System.
适应症
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 23
研究概览
简要总结
The key trial findings are summarised below: • The study medications are safe and well-tolerated • The trial showed an increase of 5 months in survival however this was not statistically significant because of the small number of participants
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 16 Years 至 80 Years（—）
- 性别
- All
入选标准
- •Patients with the types of cancer listed below who have exhausted conventional treatment options where further conventional treatment has a low prospect of a beneficial outcome.
- •They will have a Kanofsky score of at least 60 and good performance status.
- •Patients may be undergoing palliative care.
- •OCSCC-(Oral cavity squamous cell carcinoma)
- •HNsSCC-(Head and Neck skin squamous cell carcinoma)
- •GBM-(Glioblastoma)
- •MM-(metastatic melanoma)
排除标准
- •Exclusion Criteria
- •(1)Cancer patients who have a life expectancy of less than 6 months and/or the state of terminal decline;
- •(2)Patients with a Karnovsky score <60
- •(3)Patients who have failed the reasonable general health assessment and deemed not to have good performance status;
- •(4)Patients who are not motivated including noncompliance, e.g. continue to smoke, abuse
- •(5)Children less than 16 years
- •(6)Patients who are older than 80 years;
- •(7)Patients who are not competent to give consent personally
- •(8)Patients who are currently participating in or have received an investigational treatment within 30 days or 5 halflives of the investigational drug, whichever is longer
- •(9)Presence of contraindications to any of the study treatments including asthma/CORD, drug allergies, medications that interfere with the treatment
- •(10)Presence of significant immune compromise including HIV infection, organ transplant patients on immunosuppression, chronic lymphocytic leukaemia
- •(11)Patients who are pregnant or plan to be pregnant
- •(12) Patients with renal impairment
- •(13)Presence of a terminal organ failure
- •(14)A second cancer that is not expected to impact on the results of the study.
- •(15)Diabetic patients requiring treatment except those treated with Metformin.
- •(16) Connective tissue disorders.
- •(17)Patients who are on medications that increase renin levels such as calcium channel blockers and dieuretics.
研究者
相似试验
已完成
1 期
Phase I Clinical Trial of BH002 in Patients With Advanced Solid TumorsSolid TumoursNCT06231277Zhuhai Beihai Biotech Co., Ltd12
尚未招募
1 期
Phase I Study of XZ120 in Malignant TumorsAdvanced MalignanciesNCT06206915Shandong New Time Pharmaceutical Co., LTD123
已完成
2 期
CCRT for VSCCSquamous cell carcinoma of vulvaJPRN-jRCTs021180042Futagami Masayuki18
进行中（未招募）
1 期
AZD9291 in Combination With Ascending Doses of Novel TherapeuticsAdvanced Non Small Cell Lung CancerNCT02143466AstraZeneca344
已完成
不适用
Transarterial Ethanol Ablation(TEA) for Unresectable Hepatocellular Carcinoma(HCC)Hepatocellular CarcinomaNCT01837381Chinese University of Hong Kong200