a study of shr-1210 in combination with capecitabine + oxaliplatin or apatinib in treatment of advanced gastric cancer

Conditions: Gastric Cancer; GastroEsophageal Cancer

Summary: the purpose of this trial is to estimate overall response rate (orr) of shr-1210 combined with capecitabine and oxaliplatin or with apatinib as first-line treatment in subjects with locally advanced or metastatic gastric or gastroesophageal junction (gej) adenocarcinoma.

approximately 110 participants will be assigned to shr-1210 + capecitabine + oxaliplatin combination therapy (cohort 1), or shr-1210 + apatinib combination therapy (cohort 2).

Eligibility criteria:
inclusion criteria: * has histologically- or cytologically-confirmed diagnosis of locally advanced unresectable or metastatic adenocarcinoma of stomach or the esophagogastric junction (gej). * age ≥ 18 years old, male or female. * no previous therapy for advanced/metastatic disease of gc/gej (including her2 inhibitor). subjects with previous adjuvant/neo-adjuvant therapy completed more than 6 months can be enrolled. * has measurable disease per recist 1.1. * life expectancy ≥ 12 weeks. * eastern cooperative group (ecog) performance status of 0 to 1. * has adequate organ function. * females of childbearing potential (focbp), who are not surgically sterile or postmenopausal, must conduct pregnancy test (serum or urine) within 7 days before enrollment, and must not be pregnant or breast-feeding women. if the result is negative, she must agree to use adequate contraception during the experiment and 3 months after the last administration of the test drugs. and non-sterilized males who are sexually active must agree to use adequate contraception during the experiment and 3 months after the last administration of the test drugs. exclusion criteria: * has known her2-positive status. * has received prior therapy with an anti-pd-1, anti-pd-l1, or anti-ctla-4 antibody, or a vegfr inhibitor. * has known active central nervous system metastases. * has received a live vaccine within 4 weeks prior to the first dose of study treatment. * with any active autoimmune disease or history of autoimmune disease, including but not limited to the following: hepatitis, pneumonitis, uveitis, colitis (inflammatory bowel disease), hypophysitis, vasculitis, nephritis, hyperthyroidism, and hypothyroidism, except for subjects with vitiligo or resolved childhood asthma/atopy. asthma that requires intermittent use of bronchodilators or other medical intervention should also be excluded. * clinically significant cardiovascular and cerebrovascular diseases, including but not limited to severe acute myocardial infarction within 6 months before enrollment, unstable or severe angina, congestive heart failure (new york heart association (nyha) class \> 2), or ventricular arrhythmia which need medical intervention. * hypertension and unable to be controlled within normal level following treatment of anti-hypertension agents(within 3 months): systolic blood pressure \> 140 mmhg, diastolic blood pressure \> 90 mmhg. * coagulation abnormalities (inr \> 1.5 or aptt \> 1.5×uln), with bleeding tendency or are receiving thrombolytic or anticoagulant therapy.

Keywords: pd-1 shr-1210 capecitabine oxaliplatin apatinib