放射增敏剂的临床试验一般分成三个阶段。第一阶段是建立药物的最大耐受量,也可以同时研究药物的分布。第二阶段是研究不同部位,不同病理类型的肿瘤所采用的特定的放射治疗及增敏剂给药方案,这阶段主要确定安全而有效的治疗方案,因此,须要的病例数不多。第三阶段则是大数目病例的随机分组研究,来确定增敏效果。 Radiosensitizer clinical trials are generally divided into three phases. The first stage is to establish the maximum tolerated dose of the drug, and the distribution of the drug can also be studied at the same time. The second stage is to study the specific radiotherapy and sensitizer dosing regimen adopted by tumors of different sites and different pathological types. This stage mainly determines safe and effective treatment options. Therefore, the number of required cases is not large. The third stage is a randomized grouping study of a large number of cases to determine the sensitization effect.