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

• Status: Unknown status
• Trial end date: 2020-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shanghai Zhongshan Hospital
• Treatments: Antibodies; Apatinib; Immunoglobulins

Criteria

Inclusion Criteria:

1. age:18-75 years, male or femal.

2. Hepatocellular carcinoma confirmed by histopathology, Child-Pugh A .

3. BCLC staging is stage B or C, preoperative assessment of no extrahepatic metastases.

4. ECOG Performance Status 0-1.

5. 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.

6. Adequate organ function.

7. Patient has given written informed consent.

Exclusion Criteria:

1. No anti-tumor treatment for hepatocellular carcinoma, including chemotherapy and topical treatment, before surgery.

2. Known history of hypersensitivity to macromolecular protein preparation or any components of the SHR- 1210 formulation.

3. Tumors are not completely removed, or postoperative pathology suggests non-hepatocellular carcinoma or other malignant components;

4. Subjects with any active autoimmune disease or history of autoimmune disease

5. 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;

6. 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);

7. Received a live vaccine within 4 weeks of the first dose of study medication.

8. Pregnancy or breast feeding.

9. Decision of unsuitableness by principal investigator or physician-in- charge.