Clinical trial NCT03722875: SHR-1210 Plus Apatinib in Patients With Hepatocellular Carcinoma After Surgery
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hepatocellular Carcinoma
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2018-10-29
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
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-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.


Eligibility 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.

Primary outcomes:
measure: relapse-free survival(RFS)
timeFrame: 1 year
measure: Overall survival(OS)
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Zhongshan Hospital
state: Shanghai
Study officials:
References: