This is a single center phase 1 trail to observe safety and efficacy of metronomic capecitabine plus PD-L1 antibody camrelizumab as third-line regimen to treat HER2 negative advanced gastric cancer patients. This study is one of the cohorts of a multi-cohort trial called Combination of Metronomic capecitabine with Camrelizumab for treatment of refractory solid tumor (McCrest) trial.
HER2 negative advanced gastric cancer patients who have disease progression after two standard regimens will be treated by metronomic capecitabine plus camrelizumab. Metronomic capecitabine will be given as fixed dose (500mg bid) orally. Camrelizumab will be given two-weekly (200mg once) intravenously. This regimen will be administered until progression of disease, intolerable toxicity or withdraw of consent.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
This is a single-arm study with all patients receiving these two drugs.
Department of Oncology, Ruijin Hospital
Shanghai, China
RECRUITINGSafety: adverse events as assessed by CTCAE v5.0
Time frame: 48 months
Progression free survival
Time frame: 48 months
Overall survival
Time frame: 48 months
Objective response rate
Time frame: 48 months
Disease control rate
Time frame: 48 months
Duration of response
Time frame: 48 months
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