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Abstract：
BACKGROUND: Large hepatocellular carcinoma (HCC) treatment options have obvious limitations. Our trial comprises ipsilateral hepatic artery ligation and extrahepatic collaterals division (HALED, reinforced by percutaneous tumor injection controlling residual HCC arterial supply. We aimed to evaluate the long term safety and feasibility of the Combined Surgical and Injection of alcohol Treatment (COSIT) as a novel therapy for the large HCC.
METHODS: Candidates\' clinical data of the of this case series were prospectively and sequentially reported in accordance with stage 2a development IDEAL (Idea, Development, Exploration, Assessment and Long-term monitoring) recommendations. It included adult patients with HCC (diameter >5 cm) subjected to COSIT coming to our center during a five years\' trial evaluating the long term outcome measures. Study ID (NCT03138044 ClinicalTrials.gov).
RESULTS: Patients were 21, their mean age (±standard deviation) was 61·9 (±9·3) years. Eleven (52.4%) patients had tumors diameter >10 cm. 17 (80.9%) patients were advanced BCLC stage. Six modifications were made in this injection phase till it came to a stability. The mean alcohol volume was 72.0 mls. The mean follow-up duration was 16 months. The median overall survival duration was 14 months. The one, three and five years\' survival was 71.4%, 23.8% and 4.8%, respectively. Grade 3/4 and 4 Common Toxicity Criteria for Adverse Effects (v4.03) were encountered in 10 (47.6%) and one (4.8%) patients, respectively.
CONCLUSIONS: This preliminary findings of COSIT can be a promising alternative treatment for patients having large HCC. Consequently, a multicenter stage 2b Exploration IDEAL trial is suggested.
METHODS: Candidates\' clinical data of the of this case series were prospectively and sequentially reported in accordance with stage 2a development IDEAL (Idea, Development, Exploration, Assessment and Long-term monitoring) recommendations. It included adult patients with HCC (diameter >5 cm) subjected to COSIT coming to our center during a five years\' trial evaluating the long term outcome measures. Study ID (NCT03138044 ClinicalTrials.gov).
RESULTS: Patients were 21, their mean age (±standard deviation) was 61·9 (±9·3) years. Eleven (52.4%) patients had tumors diameter >10 cm. 17 (80.9%) patients were advanced BCLC stage. Six modifications were made in this injection phase till it came to a stability. The mean alcohol volume was 72.0 mls. The mean follow-up duration was 16 months. The median overall survival duration was 14 months. The one, three and five years\' survival was 71.4%, 23.8% and 4.8%, respectively. Grade 3/4 and 4 Common Toxicity Criteria for Adverse Effects (v4.03) were encountered in 10 (47.6%) and one (4.8%) patients, respectively.
CONCLUSIONS: This preliminary findings of COSIT can be a promising alternative treatment for patients having large HCC. Consequently, a multicenter stage 2b Exploration IDEAL trial is suggested.
摘要：
背景：大肝细胞癌（HCC）治疗方案具有明显的局限性。我们的试验包括同侧肝动脉结扎和肝外络脉分割(HALED，通过经皮肿瘤注射控制残余肝癌动脉供应加强。我们旨在评估联合手术和注射酒精治疗（COSIT）作为大型HCC的新疗法的长期安全性和可行性。
方法：本病例系列的候选临床数据根据2a期发展理想进行前瞻性和顺序报告（Idea，发展,探索,评估和长期监测)建议。它包括接受COSIT的成人HCC患者（直径>5cm），在五年的试验中评估长期结果指标。研究编号（NCT03138044ClinicalTrials.gov）。
结果：患者为21岁，平均年龄（±标准差）为61·9（±9·3）岁。11例(52.4%)患者肿瘤直径>10cm。17例(80.9%)患者为晚期BCLC分期。在此注入阶段进行了六次修改，直到达到稳定为止。平均酒精体积为72.0ml。平均随访时间为16个月。中位总生存期为14个月。那个,三年和五年生存率为71.4%，23.8%和4.8%，分别。在10例（47.6％）和1例（4.8％）患者中遇到了3/4级和4级常见不良反应毒性标准（v4.03）。分别。
结论：COSIT的这一初步发现可能是大肝癌患者的一种有希望的替代治疗方法。因此,建议进行多中心2b阶段探索IDEAL试验.
方法：本病例系列的候选临床数据根据2a期发展理想进行前瞻性和顺序报告（Idea，发展,探索,评估和长期监测)建议。它包括接受COSIT的成人HCC患者（直径>5cm），在五年的试验中评估长期结果指标。研究编号（NCT03138044ClinicalTrials.gov）。
结果：患者为21岁，平均年龄（±标准差）为61·9（±9·3）岁。11例(52.4%)患者肿瘤直径>10cm。17例(80.9%)患者为晚期BCLC分期。在此注入阶段进行了六次修改，直到达到稳定为止。平均酒精体积为72.0ml。平均随访时间为16个月。中位总生存期为14个月。那个,三年和五年生存率为71.4%，23.8%和4.8%，分别。在10例（47.6％）和1例（4.8％）患者中遇到了3/4级和4级常见不良反应毒性标准（v4.03）。分别。
结论：COSIT的这一初步发现可能是大肝癌患者的一种有希望的替代治疗方法。因此,建议进行多中心2b阶段探索IDEAL试验.
