A Study of SHR-1210 in Combination With Capecitabine + Oxaliplatin or Apatinib in Treatment of Advanced Gastric Cancer
Condition: Gastric Cancer; GastroEsophageal Cancer
MeSH terms: Stomach Neoplasms
Intervention: SHR-1210; Capecitabine; Oxaliplatin; Apatinib
Intervention description: SHR-1210 is a humanized anti-PD1 IgG4 monoclonal antibody; 1000 mg/m^2 administered as continuous oral twice daily (BID) of each 3-week cycle.; 130 mg/m^2 administered IV Q3W on Day 1 of each 3-week cycle.; 375 mg administered as continuous oral once daily (QD) of each 3-week cycle.
Intervention MeSH terms: Capecitabine; Oxaliplatin; Apatinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 67.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: PD-1; SHR-1210; Capecitabine; Oxaliplatin; Apatinib

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.
    

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.