Gatric cancer
Conditions
Interventions
Dose escalation in three groups:Carelizumab in Combination With Nab-paclitaxe and Apatinib
Sponsors
Affiliated Hospital of Qingdao University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-70 years male and female; 2. To be confirmed to meet the clinical diagnosis standard, histologically or cytologically confirmed HER2-negtive 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;overall survival (OS);Overall survival rate (6 months);Duration of Response (DoR);The relationship between lymphocyte subsets and efficacy; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate (ORR);Disease Control Rate (DCR); | — |
Countries
China
Contacts
Public ContactJiang Tao
Affiliated Hospital of Qingdao University
Outcome results
None listed