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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 evaluate the efficacy and safety of a novel thermosensitive embolic agent in interventional arterial embolization in the treatment of patients with unresectable advanced hepatocellular carcinoma (HCC). Methods A prospective, single arm, open, single center clinical trial of warm-embolic agent for arterial embolization of HCC was performed. Patients with clinically diagnosed advanced unresectable HCC are treated with endovascular embolization of a thermo-sensitive embolic agent until the disease progresses or does not exceed 4 cycles of treatment. Objectively evaluated the curative effect according to m RECIST criteria after operation (30 ± 7) days, and observed the progression-free time (PFS) and survival (OS). Safety Assessment: NCI-CTC Version 3.0 Standard Observations and Judgment Adverse Events and Adverse Events. Results A total of 10 patients were enrolled in the trial and 23 were treated for target lesions. 1 patient had complete remission (CR), 3 had partial remission (PR), 5 had stable (SD), 1 had progressed, the objective response rate (CR + PR) was 40%, and the disease control rate + PR + SD) 90%. The progression-free duration of PFS was 18.4 (95% CI: 14.15 to 22.65) weeks for the intrahepatic target lesion, and the median cumulative survival was 46.2 (95% CI: 38.18-54.22) weeks. Common adverse reactions are pain, fever, liver damage, a small amount of ascites, diarrhea and so on. Conclusion The new thermo-sensitive embolic agent has a non-stick tube, X-ray visualization, embolization effect is indeed easy to observe the efficacy of postoperative evaluation. The embolic agent is not perfect, there are some weaknesses and shortcomings in use. Minor adverse reactions, the patient is easy to tolerate. It is worth to try to carry out large sample randomized controlled clinical studies for tumor artery chemoembolization technology to open up more worth looking forward to.