胃癌和胃食管结合部腹膜转移患者行全身化疗序贯腹腔紫杉醇治疗的 II 期临床试验——STOPGAP 试验。
Phase II clinical trial of sequential treatment with systemic chemotherapy and intraperitoneal paclitaxel for gastric and gastroesophageal junction peritoneal carcinomatosis - STOPGAP trial.
机构信息
Division of Surgical Oncology, University of California Irvine, 3800 Chapman Ave, Ste 6400, CA, 92868, Orange, USA.
Division of Hematology Oncology, University of California Irvine, CA, Orange, USA.
出版信息
BMC Cancer. 2023 Mar 4;23(1):209. doi: 10.1186/s12885-023-10680-1.
BACKGROUND
Studies from Asia indicate that normothermic intraperitoneal chemotherapy (NIPEC) may confer survival benefit in patients with gastric peritoneal carcinomatosis (PC). However, data regarding this approach is lacking in western population. The current STOPGAP trial is intended to assess 1-year progression-free survival benefit of sequential systemic chemotherapy and paclitaxel NIPEC in patients with gastric/ gastroesophageal junction (GEJ) adenocarcinoma PC.
METHODS
This is a prospective, single center, single arm, phase II investigator-initiated clinical trial. Patients with histologically proven gastric/GEJ (Siewert 3) adenocarcinoma with positive peritoneal cytology or PC will be eligible to participate after three months of standard of care systemic chemotherapy and with no evidence of visceral metastasis on restaging scans. The primary treatment is iterative paclitaxel NIPEC with systemic paclitaxel and 5-fluorouracil, which will be administered on days1 and 8 and repeated every three weeks for 4 cycles. Patients will undergo diagnostic laparoscopy both before and after NIPEC to assess peritoneal cancer index (PCI). Patients with PCI less than or equal to 10 in whom complete cytoreduction (CRS) is feasible may opt to undergo CRS with heated intraperitoneal chemotherapy (HIPEC). The primary endpoint is 1-year progression free survival and secondary endpoints are overall survival and patient reported quality of life outcomes measured by EuroQol- 5 dimensions-5 level (EuroQol-5D-5L) questionnaire.
DISCUSSION
If the sequential approach of systemic chemotherapy followed by paclitaxel NIPEC proves beneficial, then this approach could be used in larger, muti-institutional randomized clinical trial of gastric PC.
TRIAL REGISTRATION
The trial was registered on 21/02/2021, under clinical trials.gov; Identifier: NCT04762953.
背景
亚洲的研究表明，腹腔内热灌注化疗（NIPEC）可能使胃腹膜癌转移（PC）患者获益。然而，西方人群的数据尚缺乏。目前的 STOPGAP 试验旨在评估序贯全身化疗和紫杉醇 NIPEC 对胃/胃食管交界处（GEJ）腺癌 PC 患者的 1 年无进展生存获益。
方法
这是一项前瞻性、单中心、单臂、II 期研究者发起的临床试验。组织学证实的胃/GEJ（Siewert 3）腺癌患者，在标准治疗全身化疗 3 个月后，且重新分期扫描无内脏转移证据，且腹膜细胞学阳性或 PC 阳性，有资格参加。主要治疗方法是迭代紫杉醇 NIPEC 联合全身紫杉醇和 5-氟尿嘧啶，在第 1 天和第 8 天给予，每 3 周重复 4 个周期。在 NIPEC 前后，患者都要进行诊断性腹腔镜检查，以评估腹膜癌症指数（PCI）。如果 PCI 小于或等于 10，且可行完全减瘤术（CRS），患者可选择行 CRS 联合腹腔内热灌注化疗（HIPEC）。主要终点是 1 年无进展生存，次要终点是总生存和患者报告的生活质量结局，通过欧洲五维健康量表 5 级（EuroQol-5D-5L）问卷进行评估。
讨论
如果全身化疗后序贯紫杉醇 NIPEC 的方法证明有效，那么这种方法可以在更大规模、多机构的胃 PC 随机临床试验中使用。
试验注册
该试验于 2021 年 2 月 21 日在 clinicaltrials.gov 上注册；标识符：NCT04762953。
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