SHR-1210 Plus Apatinib in Patients With Hepatocellular Carcinoma After Surgery

Study Overview
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Brief Summary
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SHR-1210 is a humanized anti-PD1 Immunoglobulin G4 (IgG4) monoclonal antibody. This is an open- label，single center ，non-randomized ，Single Arm Exploratory Study . This clinical study is an investigator-initiatedclini-cal trial（IIT ）.The objective of this study is to evaluate the efficacy and safety of adjuvant therapy with anti-PD-1 antibody SHR-1210 and apatinib in patients with Barcelona Clinic Liver Cancer (BCLC) B&C stage hepatocellular carcinoma after surgery.

Official Title
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A Single Arm Pilot Study of Programmed Cell Death Drotein 1 Antibody (PD-1） SHR-1210 Combined With Apatinib Mesylate in Patients With Intermediate And Advanced-Stage Hepatocellular Carcinoma After Radical Hepatectomy

Conditions
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Hepatocellular Carcinoma

Intervention / Treatment
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* Drug: SHR-1210
* Drug: apatinib


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age:18-75 years, male or femal. Hepatocellular carcinoma confirmed by histopathology, Child-Pugh A . BCLC staging is stage B or C, preoperative assessment of no extrahepatic metastases. ECOG Performance Status 0-1. Alpha-fetoprotein (AFP) decreased to normal，3-4 weeks after surgery. If it is not normal, it must be checked that there is no clear lesion in MRI or CT. Adequate organ function. Patient has given written informed consent. Exclusion Criteria: No anti-tumor treatment for hepatocellular carcinoma, including chemotherapy and topical treatment, before surgery. Known history of hypersensitivity to macromolecular protein preparation or any components of the SHR- 1210 formulation. Tumors are not completely removed, or postoperative pathology suggests non-hepatocellular carcinoma or other malignant components; Subjects with any active autoimmune disease or history of autoimmune disease 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; 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); Received a live vaccine within 4 weeks of the first dose of study medication. Pregnancy or breast feeding. Decision of unsuitableness by principal investigator or physician-in- charge.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SHR-1210+ apatinib<br>SHR-1210 (200mg fixed dose every 3 weeks, one cycle is three weeks, total 1 year ) will be administered as an intravenous infusion over 30 minutes. apatinib 250 mg qd ， one cycle is three weeks, total 1 year | Drug: SHR-1210<br>* SHR-1210 is a humanized anti-PD1 IgG4 monoclonal antibody.<br>* Other names: Anti-PD-1 Antibody;Drug: apatinib<br>* Apatinib is a selective VEGFR2 inhibitor<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| relapse-free survival(RFS) | from the date of enrollment to tumor recurrence or Death | 1 year | 
| Overall survival(OS) | the date of Death of any causes since the date of enrollment | 3 years |