新型温度敏感型栓塞剂用于原发性肝癌动脉栓塞的初步临床试验

A new thermosensitive embolic agent used for arterial embolization of primary hepatocellular carcinoma: preliminary clinical trial

目的尝试新型温敏型栓塞剂在介入动脉栓塞治疗中应用,评价其治疗无法手术切除的晚期肝细胞癌（HCC）患者的有效性和安全性。方法开展温敏栓塞剂针对HCC动脉栓塞治疗的前瞻性、单臂、开放性、单中心的临床研究。经临床确诊的晚期不可切除HCC患者,给予温敏栓塞剂血管内栓塞治疗;直至疾病进展或最多不超过4个治疗周期。术后（30±7）d,按照m RECIST标准评价客观疗效,观察无疾病进展时间（PFS）和生存期（OS）。安全性评估：NCI-CTC 3.0版标准观察和判定不良反应以及不良事件。结果试验共入组10例患者、23处治疗靶病灶。术后评效结果获得完全缓解（CR）1例,部分缓解（PR）3例,稳定（SD）5例,进展1例,客观缓解率（CR＋PR）为40%,疾病控制率（CR＋PR＋SD）90%。肝内靶病灶PFS无疾病进展期为18.4（95%CI：14.15~22.65）周,累积中位生存期m OS为46.2（95%CI：38.18~54.22）周。常见的不良反应为疼痛,发热,肝功能损伤,少量腹水,腹泻等。结论新型温敏栓塞剂具有不粘管,X线下可视,栓塞效果确实,易于术后观察疗效评估等特点。该栓塞剂并非完美,也存在使用中的一些弱点和不足。不良反应较轻,患者易于耐受。值得尝试开展大样本随机对照的临床研究,为肿瘤动脉化疗栓塞技术开辟更值得期待的领域。

Objective To investigate the clinical application of a new thermosensitive embolic agent in interventional arterial embolization treatment, and to evaluate its effectiveness and safety in treating inoperable advanced hepatocellular carcinoma（HCC）. Methods Prospective, open and single center clinical study of a new thermosensitive embolic agent was conducted. A total of 10 patients with clinically confirmed inoperable advanced HCC were treated with percutaneous arterial embolization using thermosensitive embolic agent; a maximum of 4 therapeutic cycles were performed until the disease progressed. Objective effect was evaluated at（30 ±7） days after the treatment according to m RECIST standard; the progression free survival（PFS） time and the survival period（OS） were recorded. The adverse reactions and adverse events were determined by NCI- CTC 3.0 version standard. Results Ten patients（23 target lesions in total） were enrolledin this study. After the treatment, complete remission（CR） was obtained in one patient, partial remission（PR）in 3 patients, stable disease（SD） in 5 patients, and progress disease（PD） in one patient. The objective response rate（CR＋PR） was 40%, and the disease control rate（CR＋PR＋SD） was 90%. The PFS of hepatic lesions was 18.4 weeks（95%CI： 14.15-22.65）, the cumulated median survival period was 46.2 weeks（95%CI： 38.18-54.22）. The most common adverse reactions included pain, fever, hepatic function damage, small amount of ascites, diarrhea, etc. Conclusion The new thermosensitive embolic agent is not sticky to vessel and is visible under X- ray; it has reliable embolization effect, and the therapeutic results can be easily evaluated. This embolic agent is not perfect, and it has some limitations in clinical use. The adverse reactions are mild, which can be easily tolerated by the patients. It is worth trying to carry out large sample and randomized controlled studies in order to open up more areas for arterial chemoembolization therapy of tumors.