Although Pembrolizumab plus trastuzumab and chemotherapy is the standard of care for first-line treatment of HER2-positive advanced or metastatic gastric or gastroesophageal junction (G/GEJ) cancer,there is no established therapy in the second-line setting. RC48 showed promising activity with manageable safety in patients with HER2-overexpressing, advanced G/GEJ cancer who have previously received at least two lines of chemotherapy.Fruquintinib in combination with Paclitaxel demonstrated encouraging preliminary clinical antitumor activity in patients with advanced GC in ph1b/2 study. This study is aimed to evaluate the efficacy and safety of Fruquintinib in combination with RC48 in the treatment of previously treated HER2-positive locally advanced or metastatic gastric or gastroesophageal junction (G/GEJ) cancer.
This study is a phase II, single arm study with main purpose to evaluate the safety, tolerability and efficacy of Fruquintinib in combination with RC48 in the treatment of previously treated HER2-positive locally advanced or metastatic gastric or gastroesophageal junction (G/GEJ) cancer. All eligible patients received Fruquintinib (4mg orally, once daily for 3 wks on/1 wk off) combined with of RC48( 2.5mg/kg by intravenous infusion during 30-90 min every 2 weeks) until investigator assessed loss of clinical benefit, unacceptable toxicity, investigator or participant decision to withdraw from therapy, or death (whichever occurs first).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
56
Fruquintinib (4mg orally, once daily for 3 wks on/1 wk off) combined with of RC48( 2.5mg/kg by intravenous infusion during 30-90 min every 2 weeks)
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Progression free survival (PFS)
Tumor assessment will be performed using radiography method every 8 weeks, until the occurrence of progressive disease (PD), using RECIST v 1.1
Time frame: from randomization up to progressive disease or EOT due to any cause, assessed up to 1 year
Overall survival (OS)
every two months follow up after EOT observation period at 30 days after the last medication
Time frame: from randomization until death due to any cause, assessed up to 3 year
Objective response rate (ORR)
Tumor assessment will be performed using radiography method every 8 weeks until the occurrence of progressive disease (PD), using RECIST v 1.1
Time frame: from randomization up to progressive disease or EOT due to any cause, assessed up to 1 year
Disease control rate (DCR)
Tumor assessment will be performed using radiography method every 8 weeks until the occurrence of progressive disease (PD), using RECIST v 1.1
Time frame: from randomization up to progressive disease or EOT due to any cause, assessed up to 1 year
Safety and tolerance evaluated by incidence, severity and outcomes of AEs
Safety and tolerance will be evaluated by incidence, severity and outcomes of AEs and categorized by severity in accordance with the NCI CTC AE Version 4.03
Time frame: from first dose to 30 days post the last dose
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