| Eligibility |
Inclusion Criteria:
1. Male or female 18-65 years of age;
2. Histologically confirmed solid tumor ;
3. Documented as advanced disease(unresectable or metastatic disease), failure to
standard therapies or lack of standard therapy;
4. ECOG performance status of 0 or 1;
5. Life expectancy = 12 weeks.;
6. Ideally, subjects enrolled have measurable lesion(s) according to RECIST
v1.1/mRECIST(liver cancer);
7. Adequate laboratory parameters during the screening period as evidenced by the
following:
1. Absolute neutrophil count = 1.5 × 109/L ;
2. Platelets = 100 × 109/L;
3. Hemoglobin = 9.0 g/dL;
4. Albumin (ALB) levels = 2.8 g/dL
5. Total bilirubin (TBIL) = 1.5 × upper limit of normal (ULN), ALT and AST = 1.5
- ULN; for subjects with liver metastases, alanine aminotransferase (ALT) and
aspartate aminotransferase (AST) = 5 × ULN;
6. Creatinine clearance=50 mL/min;
8. Female and male who have reproductive potential must be willing and able to employ a
highly effective method of birth control/contraception to prevent pregnancy while on
treatment and for at least 3 months after receiving the last dose of study treatment.
Women of childbearing potential with pregnancy test negative within 7days before
entering the group and not in in lactation;
9. Able to understand and sign an informed consent form (ICF).
Exclusion Criteria:
1. Subjects with any active autoimmune disease or history of autoimmune disease,
including but not limited to the following: interstitial pneumonia, uveitis,
enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism and
hypothyroidism, except for subjects with vitiligo or resolved childhood asthma/atopy,
asthma that requires intermittent use of bronchodilators can not be included;
2. Concurrent medical condition requiring the use of immunosuppressive medications, or
immunosuppressive doses of systemic or absorbable topical corticosteroids. Doses > 10
mg/day prednisone or equivalent are prohibited within 2 weeks before entering the
group;
3 History of organ transplantation (except corneal transplantation);
4. Known history of hypersensitivity to macromolecular protein preparation or any
components of the SHR-1210 formulation;
5 History or concurrent with other malignant disease, except completely cured basal cell
skin cancers and carcinoma in situs of cervix;
6. Presence of symptomatic central nervous system (CNS) metastases (indicated cerebral
edema, steroid requirement, or progressive disease), Subjects with brain or meningeal
metastases that were previously treated must be clinically stable (MRI) for at least 2
months, and have discontinued systemic steroids (> 10 mg/day prednisone or equivalent) for
at least 2 weeks before study drug administration;
7. Uncontrolled clinically significant heart disease, including but not limited to the
following: (1) >2 NYHA 2 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;
8. Prior radiotherapy, systemic chemotherapy (< 6 weeks if chemotherapy including
nitrosoureas or mitomycin), hormone therapy, surgery or target therapy within 4 weeks
before the study drug administration, or any unresolved AEs > CTC-AE Grade 1;
9. Active infection or an unexplained fever > 38.5°C during screening or before the first
scheduled day of dosing (subjects with tumor fever may be enrolled at the discretion of the
investigator);
10. History of immunodeficiency (HIV) or active hepatitis;
11. Participation in a clinical study or less than 1 month from the last dose of
investigational drug to sign ICF;
12. May require for other systemic anti-tumor therapy during the study period;
13. History of PD-1/PD-L1 therapy;
14. History of psychotropic substance abuse, alcoholism or drug abuse;
15. Other factors that may lead to the termination of the participation in the study at the
discretion of the investigators.
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