A Trial of SHR-1210 in Combination With SHR6390 in Patients With Advanced CRC, NSCLC and HCC

Launched by HARBIN MEDICAL UNIVERSITY · Jul 24, 2018

Keywords

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Eligibility criteria

• Inclusion Criteria:
• • Subjects voluntarily participate in this study and sign informed consent .
• • Men or women aged 18-75 years
• • Has confirmed by histology and cytology advanced and/or metastatic colorectal cancer patients, the advanced (Ⅲ B/Ⅳ period) in non-small cell lung cancer，Or patients with advanced hepatocellular carcinoma confirmed histologically or cytologically or clinically，At least one measurable lesion that meets the RECIST v1.1 criteria without local treatment.
• • The patients can swallow pills normally.
• • ECOG score was 0 or 1.
• • Have a life expectancy of at least 12 weeks.
• • The functions of vital organs meet the following requirements (excluding the use of any blood components and cytokines during screening) : Neutrophils≥1.5 x 109/L, Hb≥9g/dL; Plt≥90 x 109/L, ALB≥3g/dL, TSH≤ULN(Upper Limit Of Norma), TBIL ≤ 1.25 x ULN, ALT and AST ≤ 1.5 x ULN, AKP≤ 2.5 x ULN, CR≤ 1.5 x ULN
• • Female Subjects of childbearing potential must have a negative serum pregnancy test within 72 hours before the first dose and must be willing to use very efficient barrier methods of contraception for the course of the study through 3 months after the last dose of study treatment.
• Exclusion Criteria:
• • Subjects had any active autoimmune disease or history of autoimmune disease.
• • Subjects are using immunosuppressive agents, or systemic, or absorptive,local hormone therapy to achieve immunosuppression. It is still in use within 2 weeks before enrollment.
• • Subjects with severe allergic reactions to other monoclonal antibodies.
• • The subjects had a central nervous system metastases of clinical symptoms.
• • Central lung squamous cell carcinoma, or NSCLC with large vascular invasion confirmed by imaging.
• • A heart condition or disease that is not well controlled.
• • Subjects had active infections.
• • Other clinical trials of drugs were used within 4 weeks prior to the first administration.
• • The subjects have received other PD-1 antibody therapy or other immunotherapy for PD-1 / PD-L1 or CDK4/6 inhibitor treatment in the past.
• • There are other factors lead to patients can not participate in this clinical study by the judgment of the investigator.