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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
53
Fruquintinib:5mg qd for 2 weeks on and 1 week off, q3w; SOX: Tegafur gimeracil oteracil potassium capsule: 40-60mg bid(dosage according to body surface area),d1-14,q3w; Oxaliplatin:130mg/m2,intravenous (IV) ,d1,q3w.
Guangxi Medical University Cancer Hospital
Nanning, China
RECRUITINGPathological remission rate (PRR)
Rate of patients with \< 2/3 residual tumor lesion (Grade 1b, 2, 3) in surgical specimen compared to baseline
Time frame: Approximately 2 years
Disease free survival (DFS)
Disease free survival Time from randomization to relapse or death from any cause
Time frame: Approximately 2 years
Overall Survival (OS)
Overall survival Time from randomization to death from any cause
Time frame: Approximately 2 years
Objective response rate (ORR)
Rate of patients with complete remission (CR) or partial remission (PR) based on RESIST1.1
Time frame: Approximately 2 years
Major pathological response rate (MPR)
Less than 10% residual carcinoma cells in the specimen
Time frame: 30 days
R0 resection rate
Evaluation of the resection margin status (positive or negative) in the rectal specimen
Time frame: 30 days
Liucheng Wu
CONTACT
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