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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
64
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.
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
RECRUITINGDLTs
DLTs are defined as grade 3 or higher adverse events that are related to fruquintinib during the first cycle of therapy.
Time frame: At the end of Cycle 1 (each cycle is 28 days)
RP2D
Maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D)
Time frame: At the end of Cycle 1 (each cycle is 28 days)
PFS
PFS was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first.
Time frame: about 2 years
OS
The time from treatment initiation until death from any reason
Time frame: about 2 years
ORR
The proportion of patients with a confirmed complete response or partial response on two consecutive occasions≥4 weeks apart
Time frame: about 2 years
DCR
The proportion of patients with a best overall response of confirmed complete or partial response, or stable disease (CR+ PR + SD)
Time frame: about 2 years
DoR
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
Time frame: about 2 years
adverse events (AEs) categorized by severity in accordance with the NCI CTC AE Version 5.0
Qingxia Fan, M.D.
CONTACT
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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
Time frame: about 2 years