Neoadjuvant chemotherapy with gemcitabine plus cisplatin followed by radical liver resection versus radical liver resection alone in incidentally detected gallbladder carcinoma after simple cholecystectomy – A phase III study utilizing the German Registry

在简单胆囊切除术后偶然发现的胆囊癌中，使用吉西他滨加顺铂进行新辅助化疗，然后进行根治性肝切除术与单纯根治性肝切除术比较 – 利用德国注册中心进行的一项 III 期研究

• 批准号: 316590476
• 负责人: Professor Dr. Thorsten Oliver Götze
• 金额: --
• 依托单位: Institut für Klinisch-Onkologische Forschung (IKF)
• 依托单位国家: 德国
• 项目类别: Clinical Trials
• 财政年份: 2017
• 资助国家: 德国
• 起止时间: 2016-12-31 至 2022-12-31
• 项目状态: 已结题
• 来源: https://gepris.dfg.de/gepris/projekt/316590476?language=en
• 关键词: Neoadjuvant; chemotherapy; gemcitabine; plus; cisplatin

Gallbladder carcinoma is the fifth most common neoplasm of the digestive tract, with an overall 5-year survival less than 5%. Due to the high frequency of laparoscopic cholecystectomies (LC), more incidental findings of gallbladder carcinomas are diagnosed. 2/3 of gallbladder carcinomas are so called incidental gallbladder carcinomas (IGBC). Cases IGBC in Germany are registered in theGerman Registry of Incidental Gallbladder Carcinoma (GR) overseen by the PI of the current trial. Stage-adjusted therapy includes second radical surgery of the liver and lymphadenectomy after LC (IRR -immediate radical re-resection). According to the S3 Guidelines in Germany this is recommended in cases of T2 and more advanced T-stages.There are two main problems in the curative management of IGBC. First of all, surgical management of gallbladder cancer remains inadequate [1-3]. Only 49% of T2-T3 carcinomas in the GR underwent the recommended IRR. In the study proposed, all trial patients will receive the IRR as mandatory part of the study design.Secondly, even after radical surgery, the outcome pT2-3 carcinomas – which notably represent the majority of the tumors, remains poor [3]. According to the GR, the 5-year OS of T2 is 38% with and 22% without IRR [7, 11]. In T3 it is 18% with and 12% without IRR [7, 11]. Cure of such patients by a pure surgical concept does not seem to be achievable. The encouraging results of multimodal concepts in esophagogastric-, rectal-, and other malignancies provide an additional rationale to use this kind of treatment in the early phase of IGBC management. Patients in the trial will be randomized to IRR +/- perioperative chemotherapy. Primary endpoint is OS.

胆囊癌是消化道第五大常见肿瘤，总体5年生存率低于5%。由于腹腔镜胆囊切除术（LC）的高频率，更多的偶然发现被诊断为胆囊癌。2/3的胆囊癌被称为偶发胆囊癌（IGBC）。在德国，IGBC病例登记在德国偶然胆囊癌登记处（GR），由当前试验的PI监督。分期调整治疗包括LC后的第二次肝脏根治性手术和淋巴结切除术（IRR -立即根治性再切除术）。根据德国的S3指南，建议在T2和更晚期的t期病例中使用这种方法。在IGBC的治疗管理中有两个主要问题。首先，胆囊癌的手术治疗仍然不足[1-3]。GR中只有49%的T2-T3癌接受了推荐的IRR。在本研究中，所有试验患者都将接受IRR作为研究设计的强制性部分。其次，即使在根治性手术后，pT2-3癌（明显代表大多数肿瘤）的预后仍然很差。根据GR， T2的5年OS有IRR为38%，无IRR为22%[7,11]。T3有IRR为18%，无IRR为12%[7,11]。单纯的手术治疗似乎是无法实现的。多模式概念在食管、胃、直肠和其他恶性肿瘤中的令人鼓舞的结果为在IGBC治疗的早期阶段使用这种治疗提供了额外的理由。试验中的患者将随机接受IRR +/-围手术期化疗。主要端点是操作系统。