A phase II study of perioperative treatment in gastric cancer with No.16a2/b1 lymph node metastasis: DRAGON-06 trial.
Sheng LuYi-Gang ChenXiao-Wen LiuZhong-Yin YangMin ShiHong YuanWen-Tao LiuZhen-Tian NiXue-Xin YaoZi-Chen HuaRun-Hua FengChang-Yu HeYa-Nan ZhengZhen-Qiang WangBirendra Kumar SahMing-Min ChenZheng-Lun ZhuChen LiJun ZhangMin YanJia-Zeng XiaZheng-Gang ZhuPublished in: Future oncology (London, England) (2023)
Although gastric cancer with para-aortic lymph node (PAN) metastasis is commonly regarded as unresectable, surgeons have explored the optimal treatment for patients with PAN metastases limited to No.16a2/b1 in the past few decades. Preoperative systemic therapy combined with D2 gastrectomy plus PAN dissection may improve the prognosis of these patients. In this multicenter phase II trial, 29 gastric cancer patients with PAN metastasis limited to No.16a2/b1 will receive preoperative treatment with nab-paclitaxel, oxaliplatin, S-1 (nab-POS: nab-paclitaxel, oxaliplatin, S-1) and sintilimab followed by D2 gastrectomy plus PAN dissection; and postoperative treatment with oral S-1, intravenous sintilimab and intraperitoneal paclitaxel. The end points for the study are 3-year overall survival, 3-year disease-free survival, pathological response rate, incidence of postoperative complications and adverse events.
Keyphrases
- patients undergoing
- lymph node
- lymph node metastasis
- phase ii study
- free survival
- squamous cell carcinoma
- clinical trial
- open label
- risk factors
- advanced non small cell lung cancer
- stem cells
- end stage renal disease
- radiation therapy
- heart failure
- aortic valve
- combination therapy
- locally advanced
- mesenchymal stem cells
- patient reported outcomes
- rectal cancer
- cell therapy
- epidermal growth factor receptor
- drug induced
- double blind