JPRN-jRCT2051210144招募中1 期
Phase I investigator-initiated clinical trial in patients with differentiated thyroid cancer (papillary cancer, follicular cancer) by the targeted alpha therapy drug TAH-1005 ([211At] NaAt) - Alpha-T1 study
Watabe Tadashi0 个研究点目标入组 32 人开始时间: 2021年12月28日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 32
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1) Patients with differentiated thyroid cancer (papillary cancer, follicular cancer) after total thyroidectomy who meet the following conditions (1) resistance to standard treatment or (2) difficulty in continuing standard treatment
- •(1) Patients who are refractory to standard treatment such as 131I-NaI treatment
- •Insufficient therapeutic effect after 3 or more 131I-NaI treatments. 131I-NaI treatment resistance and difficulty in performing or continuing tyrosine kinase inhibitor (TKI) treatment
- •(2) Patients who have difficulty continuing standard treatment such as 131I-NaI treatment
- •Ablation for residual thyroid or 131I-NaI treatment for relapsed / metastatic lesions has been performed, but relapsed / metastatic lesions were observed at the time of participation in this study, and 131I-NaI is the standard treatment. If it is difficult to continue treatment or if local radiation therapy (including addition) is not indicated (if it is not 131I-NaI treatment resistant, TKI treatment is not indicated).
- •2) Patients aged 18 years or older at the time of consent acquisition
- •3) Patients with stable general condition with PS (Performance status) of 0 to 2 in ECOG (Eastern Cooperative Oncology Group)
- •4) Patients who can be expected to survive for 6 months or more, judging from clinical symptoms and medical examination findings
- •5) Patients with no or controlled brain metastases with symptoms
- •6) Patients with no clinically significant abnormal findings in electrocardiogram, respiratory rate, and blood oxygen saturation within 30 days before registration
- •7) Patients whose laboratory values within 30days before the enrollment are within the range specified in the protocol
- •8) Patients who thoroughly listened to the explanation of the clinical trial, agreed to the examination, visit during the observation period and follow-up survey, contraception during the clinical trial period, etc. according to the clinical trial protocol, and signed the consent document.
排除标准
- •1) Patients who need fertility preservation
- •2) Pregnant or potentially pregnant women, lactating patients
- •3) Patients with active double cancer (simultaneous double cancer and ectopic double cancer with a disease-free period of 5 years or less)
- •4) Patients who received other investigational or unapproved drugs within 5 weeks prior to enrollment
- •5) Patients who received chemotherapy, immunotherapy or radiation therapy within 8 weeks prior to enrollment in this study
- •6) Patients with uncontrollable active infections
- •7) HBsAg positive, HCV antibody positive or HIV antibody positive patients
- •8) Patients with mental illness or psychiatric symptoms who are judged to be difficult to participate in clinical trials
- •9) Other patients who are judged to be inappropriate by the investigator, etc.
研究者
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