A phase III trial of neoadjuvant intraperitoneal and systemic chemotherapy for gastric cancer with peritoneal metastasis

• Published in: Future oncology (London, England) England), 2022-03, Vol.18 (10), p.1175-1183
• Main Authors: Lu, Sheng, Yang, Zhong-Yin, Yan, Chao, Liu, Wen-Tao, Ni, Zhen-Tian, Yao, Xue-Xin, Hua, Zi-Chen, Feng, Run-Hua, Zheng, Ya-Nan, Wang, Zhen-Qiang, Sah, Birendra Kumar, Chen, Ming-Min, Zhu, Zheng-Lun, He, Chang-Yu, Li, Chen, Yan, Min, Zhu, Zheng-Gang
• Format: Article
• Language: English
• Subjects: Antineoplastic Combined Chemotherapy Protocols - therapeutic use; Clinical Trials, Phase III as Topic; gastric cancer; Humans; intraperitoneal–systemic chemotherapy; Multicenter Studies as Topic; neoadjuvant chemotherapy; Neoadjuvant Therapy; Neoplasm Staging; overall survival; Paclitaxel - therapeutic use; peritoneal carcinomatosis; Peritoneal Neoplasms - secondary; Peritoneal Neoplasms - therapy; Prospective Studies; Randomized Controlled Trials as Topic; Stomach Neoplasms - pathology; Stomach Neoplasms - therapy
• ISSN: 1479-6694; 1744-8301
• DOI: 10.2217/fon-2021-1414

Although recent advances in systemic chemotherapy have improved the clinical outcomes of gastric cancer patients with peritoneal metastasis, the peritoneum still represents a common site of treatment failure and disease recurrence. Neoadjuvant intraperitoneal–systemic chemotherapy has been acknowledged as a more aggressive treatment for gastric cancer patients with peritoneal metastasis. In this multicenter phase III randomized controlled trial, 238 patients will be randomly separated into two groups in a 2:1 ratio after laparoscopic exploration. The experimental arm will receive the proposed neoadjuvant intraperitoneal–systemic chemotherapy regimen, whereas the control group will receive a Paclitaxel + S-1 (PS) chemotherapy regimen. The endpoints for the study are overall survival, response rate, gastrectomy radicality rate, progression-free survival and adverse events. Recent advances in technology have improved the outcomes of stomach cancer patients. However, there are still many patients who die of cancer that has spread from another part of the body. Neoadjuvant intraperitoneal–systemic chemotherapy has been acknowledged as a more aggressive treatment for stomach cancer patients with peritoneal metastasis (cancer that has spread to the very thin layer of tissue on the inside of the abdomen that covers the stomach and other organs). In this study, 238 patients will be randomly separated into two groups in a 2:1 ratio after evaluation. The experimental group will receive the proposed neoadjuvant intraperitoneal–systemic chemotherapy regimen, whereas the control group will receive a Paclitaxel + S-1 (PS) chemotherapy regimen. The endpoints for the study are how long patients live, number of patients who respond to treatment, number of patients who undergo surgery, how long patients live without their disease getting worse and problems caused by treatment. .