This is a study of Camrelizumab combined with Apatinib versus Apatinib alone in the third-line treatment of metastatic gastric cancer. Paticipants will be radomized to receive treatment of Camrelizumab combined with Apatinib or Apatinib alone. The primary study hypothesis is that the adding Camrelizumab to Apatinib can prolong the progressive-free survival of the paticipants.
Camrelizumab 200mg intravenously 30 - 60 min biweekly; Apatinib mesylate 250mg or 500mg oral daily continuously; The treatment lasts for up to 2 years or until disease progression, death or intolerable toxicity occurred.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
68
a PD-1 antibody
an oral tyrosine kinase inhibitor
The Sixth Affiliated hosipital, Sun Yat-Sen University
Guangzhou, Guangdong, China
Progression-free survival
the interval from randomization to tumor progression or death or the last follow-up
Time frame: 1 year
Overall Survival
the interval from randomization to death of any reason or the last follow-up
Time frame: 2 years
Objective response rate
the proportion of subjects who achieve a best response of complete response (CR) or partial response (PR) using the RECIST 1.1 criteria
Time frame: 2 years
Quality of Life assessed by EORTC QLQ-OG 25
The Europe Organization for Research and Treatment of Cancer,Quality of Life Questionnaire-OG 25 can assess quality of life (HRQL) in patients with tumours of the oesophagus, oesophago-gastric junction and stomach.
Time frame: 2 years
Toxicity assessed by CTCAE V5.0
Adverse effects recorded according to CTCAE V5.0
Time frame: 2 years
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