Universidade de São Paulo, Cancer Institute, Faculty of Medicine, Department of Gastroenterology - São Paulo (SP), Brazil.
Universidade de São Paulo, Cancer Institute, Faculty of Medicine, Department of Radiology and Oncology - São Paulo (SP), Brazil.
Arq Bras Cir Dig. 2023 Jul 17;36:e1744. doi: 10.1590/0102-672020230026e1744. eCollection 2023.
Peritoneal carcinomatosis in gastric cancer is considered a fatal disease, without expectation of definitive cure. As systemic chemotherapy is not sufficient to contain the disease, a multimodal approach associating intraperitoneal chemotherapy with surgery may represent an alternative for these cases.
The aim of this study was to investigate the role of intraperitoneal chemotherapy in stage IV gastric cancer patients with peritoneal metastasis.
This study is a single institutional single-arm prospective clinical trial phase II (NCT05541146). Patients with the following inclusion criteria undergo implantation of a peritoneal catheter for intraperitoneal chemotherapy: Stage IV gastric adenocarcinoma; age 18-75 years; Peritoneal carcinomatosis with peritoneal cancer index<12; Eastern Cooperative Oncology Group 0/1; good clinical status; and lab exams within normal limits. The study protocol consists of four cycles of intraperitoneal chemotherapy with paclitaxel associated with systemic chemotherapy. After treatment, patients with peritoneal response assessed by staging laparoscopy undergo conversion gastrectomy.
The primary outcome is the rate of complete peritoneal response. Progression-free and overall survivals are other outcomes evaluated. The study started in July 2022, and patients will be screened for inclusion until 30 are enrolled.
Therapies for advanced gastric cancer patients have been evaluated in clinical trials but without success in patients with peritoneal metastasis. The treatment proposed in this trial can be promising, with easy catheter implantation and ambulatory intraperitoneal chemotherapy regime. Verifying the efficacy and safety of paclitaxel with systemic chemotherapy is an important progress that this study intends to investigate.
胃癌腹膜转移被认为是一种致命疾病，无法治愈。由于全身化疗不足以控制疾病，因此将腹腔内化疗与手术相结合的多模式方法可能是这些病例的一种替代选择。
本研究旨在探讨腹腔内化疗在伴有腹膜转移的 IV 期胃癌患者中的作用。
这是一项单机构、单臂、前瞻性 II 期临床试验（NCT05541146）。符合以下纳入标准的患者接受腹腔内化疗的腹腔置管术：IV 期胃腺癌；年龄 18-75 岁；腹膜癌指数<12 的腹膜转移；东部肿瘤协作组 0/1；良好的临床状态；实验室检查在正常范围内。研究方案包括四个周期的紫杉醇腹腔内化疗联合全身化疗。治疗后，通过分期腹腔镜检查评估腹膜反应的患者接受转化性胃切除术。
主要结局是完全腹膜反应率。无进展生存期和总生存期是评估的其他结局。该研究于 2022 年 7 月开始，将筛选 30 名患者入组。
临床试验已经评估了晚期胃癌患者的治疗方法，但对伴有腹膜转移的患者无效。该试验中提出的治疗方法可能具有前景，因为其腹腔内化疗的导管植入简单，且可在门诊进行。验证紫杉醇联合全身化疗的疗效和安全性是本研究旨在调查的一个重要进展。
