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Oxaliplatin

phase Ib: fruquintinib (dose finding): L1: 3 mg/d，L2: 4 mg/d，L3: 5 mg/d, qd po, D1-14, Q3W toripalimab: 240mg, I.V., D1, Q3W; S-1: 40-60mg bid, D1-14, Q3W; Oxaliplatin: 130mg/m\^2, ivgtt 2h, D1,Q3W. phase II: fruquintinib: RP2D toripalimab: 240mg, I.V., D1, Q3W; S-1: 40-60mg bid, D1-14, Q3W; Oxaliplatin: 130mg/m\^2, ivgtt 2h, D1,Q3W.

fruquintinib＋toripalimab + SOX

Feng Wang, M.D.

Qingxia Fan, M.D.

Feng Wang, doctor

Qingxia Fan, doctor

This is a prospective, open-label, multicenter, single arm phase Ⅰb/Ⅱ clinical study aims to explore the efficacy and safety of fruquintinib combined with toripalimab and SOX regimen in the first-line treatment of unresectable advanced metastatic gastric or gastroesophageal junction adenocarcinoma.

At present, the first-line standard treatment of metastatic gastric cancer is still doublet or triplet chemotherapy of fluorouracil combined with platinum or paclitaxel. In recent years, immune checkpoint inhibitors (ICIs) have emerged in advanced gastric cancer with their unique mechanism of action. PD-1 monoclonal antibody has been explored in multiple combination schemes in the first-line treatment of advanced gastric cancer. This study aims to explore the efficacy and safety of an antiangiogenetic TKI, fruquintinib combined with an ICI, toripalimab and the standard doublet SOX regimen in the first-line treatment of unresectable advanced metastatic gastric or gastroesophageal junction adenocarcinoma.

Fruquintinib Combined With Toripalimab and SOX Regimen in the First-line Treatment of Advanced Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma

An Open Label, Single Arm, Multicenter Phase Ⅰb/Ⅱ Clinical Study of Fruquintinib Combined With Toripalimab and SOX Regimen in the First-line Treatment of Advanced Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma

DLTs are defined as grade 3 or higher adverse events that are related to fruquintinib during the first cycle of therapy.

Maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D)

PFS was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first.

The time from treatment initiation until death from any reason

The proportion of patients with a confirmed complete response or partial response on two consecutive occasions≥4 weeks apart

The proportion of patients with a best overall response of confirmed complete or partial response, or stable disease (CR+ PR + SD)

Duration of Response is defined as the time from the first documentation of response (PR or better) to the first documented disease progression evidence (according to RECIST 1.1) of the responders

Safety and tolerance will be evaluated by incidence, severity and outcomes of adverse events (AEs) and categorized by severity in accordance with the NCI CTC AE Version 5.0

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Fruquintinib Combined With Toripalimab and SOX Regimen in the First-line Treatment of Advanced Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma	NCT05024812	Metastatic Gast...	fruquintinib＋to...	18 Years - 75 Years	The First Affiliated Hospital of Zhengzhou University
Fruquintinib Combined With Toripalimab and SOX Regimen in the First-line Treatment of Advanced Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma	NCT05024812	Metastatic Gast...	fruquintinib＋to...	18 Years - 75 Years	The First Affiliated Hospital of Zhengzhou University
Fruquintinib Combined With Toripalimab and SOX Regimen in the First-line Treatment of Advanced Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma	NCT05024812	Metastatic Gast...	fruquintinib＋to...	18 Years - 75 Years	The First Affiliated Hospital of Zhengzhou University

Spots Global Cancer Trial Database for fruquintinib＋toripalimab + sox