Background: Intraperitoneal paclitaxel is proved to be efficient for peritoneal metastasis of gastric cancer. It remains uncertain the efficacy and safety of the triplets regimen which combined intraperitoneal high-dose paclitaxel with systemic SOX in gastric cancer patients with peritoneal metastasis. This study aimed to evaluate the efficacy and safety of intraperitoneal administration of high-dose paclitaxel, intravenous oxaliplatin and S-1 in patients with peritoneal metastatic gastric cancer.Methods: This single-center, prospective, single-arm phase II study was conducted between January 2017 and May 2019 in West China Hospital, Sichuan University. Patients diagnosed with primary gastric cancer by histopathology and confirmed synchronous peritoneal metastasis were enrolled. This study aimed to evaluate efficacy and safety of intraperitoneal administration of high-dose paclitaxel (80 mg/m 2 , d1), intravenous oxaliplatin (100 mg/m 2 , d1), and S-1 (80 mg/ m 2 , d1-14) of patients. The primary endpoint was 1-year overall survival rate, and the second endpoints were progression-free survival (PFS), overall survival (OS), overall response rate (ORR), disease control rate (DCR) and adverse events. Results:In this single-arm phase II clinical trial, 49 patients received SOX combined intraperitoneal high-dose paclitaxel treatment. One-year survival rate was 81.6% (95% CI, 68.6-90.0%). Median PFS and OS were 6.50 months (95% CI, 2.89-10.11) and 16.9 months (95% CI, 13.58 to 20.22), respectively; ORR was 55.3% (95% CI, 41.3-68.6) and DCR was 76.6% (95% CI, 62.8-86.4). Thirteen patients underwent second laparoscopic detection, but only nine ultimately underwent radical gastrectomy. Subgroup analysis showed that sPCI ≤12 was a good index for a favorable prognosis. The most frequent grade 3/4 toxicities were neutropenia (40.8%), anemia (22.4%), leukopenia (18.4%), nausea (14.3%), and How to cite this article: Tu L, Zhang W, Ni L, et al. Study of SOX combined with intraperitoneal high-dose paclitaxel in gastric cancer with synchronous peritoneal metastasis: A phase II single-arm clinical trial.

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Background: A combination of fluoropyrimidines and platinum is widely accepted as the standard first-line treatment for advanced gastric and gastroesophageal adenocarcinomas. However, the benefit compared with platinum-free chemotherapeutic regimens remains controversial. We compared the efficacy and safety of capecitabine with oxaliplatin or docetaxel, as first-line therapy in advanced gastric cancer. Methods: Eligible patients were randomly assigned to receive either capecitabine and oxaliplatin (XELOX) (capecitabine 1,000 mg/m2; twice daily for 14 days with oxaliplatin 130 mg/m2 on day 1, every 21 days), or DX (capecitabine 1,000 mg/m2; twice daily for 14 days with docetaxel 75 mg/m2 on day 1, every 21 days). The primary endpoint was the objective response rate (ORR). Secondary endpoints included the disease control rate (DCR), progression-free survival, overall survival, and prespecified safety endpoints. Results: Ninety patients were enrolled in the West China Hospital from April 2012 to August 2016; a total of 83 and 66 patients were eligible for safety and efficacy analyses, respectively. Between the XELOX and DX groups, ORR (24.2% vs 24.2%, p = 1.000), DCR (90.9% vs 75.8%, p = 0.099), progression-free survival (6.1m vs 4.1m, p = 0.346), and overall survival (8.8m vs 9.0m, p = 0.973) were similar. There was no significant difference in toxicity between the two regimens. The frequent grade 3 or higher toxicities in the XELOX and DX groups were peripheral neuropathy and hematological toxicity, respectively. Toxicity was tolerable; no treatment-related deaths occurred in either group. Conclusions: The DX regimen was not superior to XELOX, but instead, similar. The platinum-containing regimen remains the preferred first-line option for advanced gastric and gastroesophageal adenocarcinomas, and DX might be considered as an alternative for patients unsuitable for platinum-containing chemotherapy.

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