Spots Global Cancer Trial Database for Fruquintinib Plus SOX as Neoadjuvant Therapy for Locally Advanced Gastric Adenocarcinoma

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Trial Identification

Brief Title: Fruquintinib Plus SOX as Neoadjuvant Therapy for Locally Advanced Gastric Adenocarcinoma

Official Title: A Single-arm, Multicenter, Open-label Phase II Study of Fruquintinib Plus SOX as a Neoadjuvant Therapy for Locally Advanced Gastric or Gastroesophageal Junction Adenocarcinoma

Study ID: NCT05122091

Conditions

Gastric Cancer

GastroEsophageal Cancer

Fruquintinib

SOX

Interventions

Fruquintinib + SOX

Study Description

Brief Summary: For locally advanced gastric/gastroesophageal junction adenocarcinoma (cT3/4aN+M0 ), neoadjuvant therapy can downstage T and N stage, improve R0 resection rate, reduce recurrence and metastasis rates, and finally improve the long-term survival. A combination of Fruquintinib and SOX for locally advanced gastric/gastroesophageal junction adenocarcinoma could be a novel therapy. This study intends to evaluate the efficacy of Fruquintinib plus SOX as neoadjuvant therapy for locally advanced gastric or gastroesophageal junction adenocarcinoma.

Detailed Description: Gastric cancer (GC) is one of the leading causes of cancer-related deaths worldwide and a substantial global health burden. Surgery is the only possible way to cure gastric cancer, however, more than 80% of Chinese patients are diagnosed at advanced stages. Surgery and comprehensive treatment have made significant progress in gastric/gastroesophageal junction adenocarcinoma, but recurrence and metastasis are still common. Improving the R0 resection rate and reducing recurrence and metastasis rates are becoming more urgent. For locally advanced gastric/gastroesophageal junction adenocarcinoma (cT3/4aN+M0 ), neoadjuvant therapy can downstage T and N stage, improve R0 resection rate, reduce recurrence and metastasis rates, and finally improve the long-term survival. A combination of Fruquintinib and SOX for locally advanced gastric/gastroesophageal junction adenocarcinoma could be a novel therapy. This single-arm, multicenter, open-label phase II study is designed to evaluate the efficacy and safety of Fruquintinib plus SOX as neoadjuvant therapy for locally advanced gastric or gastroesophageal junction adenocarcinoma who have not received prior antitumor therapy.