Gatric cancer
Conditions
Interventions
single arm:Carelizumab combined with Capecitabine and Apatinib
Sponsors
The Affiliated Hospital of Qingdao University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1 Aged 18-70 years, both genders. 2 To be confirmed to meet the clinical diagnosis standard, histologically or cytologically confirmed gastric cancer. 3 Patients must be failed from previous systemic chemotherapy or metastasis or Recurrence within 6 months after adjuvant chemotherapy. 4 Patients must have at least 1 lesion that is measurable using RECIST v1.1 criteria. 5 Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1. 6 Life expectancy of at least 3 months. 7 Patients must have adequate organ function. 8 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. 9 Patients join the study voluntarily, sign a consent form, have good compliance, and comply with follow-up.
Exclusion criteria
Exclusion criteria: 1 Subjects with any active autoimmune disease or history of autoimmune disease; 2 Uncontrolled clinically significant heart disease, including but not limited to the following: (1) > NYHA II congestive heart failure; (2) unstable angina; (3) myocardial infarction within the past 1 year; (4) clinically significant supraventricular arrhythmia or ventricular arrhythmia requirement for treatment or intervention; 3 Concurrent medical condition requiring the use of cortisol (>10mg/day Prednisone or equivalent dose) or other systematic immunosuppressive medications within 14 days before the study treatment. Except: inhalation or topical corticosteroids. Doses > 10 mg/day prednisone or equivalent for replacement therapy; 4 Has received prior anti-cancer monoclonal antibody (mAb), chemotherapy, targeted small molecule therapy within 4 weeks prior to first dosing or not recovered to 38.5°C before two weeks of first dosing ; 6 Currently participating or has participated in a study within 4 weeks of the first dose of study medication; 7 Received a live vaccine within 4 weeks of the first dose of study medication. 8 Pregnancy or breast feeding; 9 Prior therapy with a PD-1, anti-PD-Ligand 1 (PD-L1) or CTLA-4 agent; 10 Subjects are known to have a history of psychiatric substance abuse, alcoholism, or drug addiction.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety;Progression-free surviva (PFS);overall survival (OS);Overall survival rate (6 months);Objective Response Rate (ORR);Disease Control Rate (DCR);Duration of Response (DoR); | — |
Countries
China
Contacts
Public ContactJiang Tao
The Affiliated Hospital of Qingdao University
Outcome results
None listed