Clinical trial NCT04014101: SHR-1210 Plus Apatinib in Patients With Advanced-Stage Hepatocellular Carcinoma
Official title: A Single Arm Pilot Study of Programmed Cell Death Protein 1 Antibody (PD-1# SHR-1210 Combined With Apatinib Mesylate in Patients With Advanced-Stage Hepatocellular Carcinoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Hepatocellular Carcinoma
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2019-07-10
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: SHR-1210 is a humanized anti-PD-1 Immunoglobulin G4 (IgG4) monoclonal antibody. This is an open- label#single center #non-randomized #Single Arm Exploratory Study . This clinical study is an investigator-initiated clinical trial(IIT) .The objective of this study is to evaluate the efficacy and safety of therapy with anti-PD-1 antibody SHR-1210 and apatinib in patients with advanced stage hepatocellular carcinoma.


Eligibility criteria: Inclusion Criteria:

* 1.≥18 years old, male or female 2.Advanced liver cancer (cannot be removed or metastasized) diagnosed clinically or pathologically, at least one measurable lesion without local treatment, Child-Pugh A ;Barcelona Clinic Liver Cancer(BCLC) staging is stage B or C 3.Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1 4.Patient has given written informed consent. 5.Previous treatment failure with sorafenib or rivastatin (disease of disease or toxicity) or unwillingness to accept, economically unsustainable sorafenib treatment; 6.The function of important organs meets the requirements 7.Expected survival ≥12 weeks 8.Non-surgical sterilization or women of childbearing age need to use a medically-accepted contraceptive (such as an intrauterine device, contraceptive or condom) during the study period and within 3 months after the end of the study treatment period; non-surgical sterilization Female patients of childbearing age must have a negative serum or urine human chorionic gonadotropin(HCG) test within 72 hours prior to study enrollment; and must be non-lactating; for male patients with maternal age, they should be given SHR-1210 during the trial and after the last 3 effective methods of contraception within a month.

Exclusion Criteria:

- 1.The patient has any active autoimmune disease or a history of autoimmune disease (such as the following, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, nephritis, thyroid Hyperfunction; patients with vitiligo; complete remission of asthma in childhood, can be included without any intervention after adulthood; asthma patients who require bronchodilators for medical intervention cannot be included); 2.The patient is using immunosuppressive agents or systemic hormonal therapy to achieve immunosuppressive purposes (agents amount \> 10 mg / day of prednisone or other therapeutic hormones), and continue to use within 2 weeks before enrollment; 3.Have clinical symptoms or disease that are not well controlled 4.Significant clinically significant bleeding symptoms or a clear bleeding tendency within 3 months prior to randomization 5.Arterial/venous thrombosis in the first 6 months of randomization 6.According to the investigator, the patient has other factors that may affect the results of the study or lead to the termination of the study, such as alcohol abuse, drug abuse, other serious diseases (including mental illness) requiring combined treatment, and serious laboratory abnormalities.，with family or social factors, it will affect the safety of patients.

7.Liver tumor burden greater than 50% of the total liver volume, or patients who have previously undergone liver transplantation;Known for a history of central nervous system metastasis or hepatic encephalopathy;Severe allergic reactions to other monoclonal antibodies;

Primary outcomes:
measure: Objective response rate(ORR)
timeFrame: 2 years
Secondary outcomes:
measure: Progression free survival(PFS)
timeFrame: 2 years
measure: To the relief time (TOR)
timeFrame: 2 years
measure: Duration of relief(DOR)
timeFrame: 2 years
measure: Disease Control Rate (DCR)
timeFrame: 2 years
measure: 9-month survival rate
timeFrame: 9-month
measure: 12-month survival rate
timeFrame: 12-month
measure: Overall survival (OS)
timeFrame: 10 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Zhongshan Hospital
state: Shanghai
Study officials:
References: