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

Not Applicable

• Conditions: Hepatocellular Carcinoma
• Interventions: Drug: SHR-1210; Drug: apatinib

• Registration Number: NCT03722875
• Lead Sponsor: Shanghai Zhongshan Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2018-10
• Study First Submitted: 2018-10-25
• Study First Submitted QC: 2018-10-25
• Study First Posted: 2018-10-29
• Study Start: 2018-12-01
• Last Update Submitted: 2018-12-16
• Last Update Posted: 2018-12-19
• Primary Completion: 2019-03-01
• Study Completion: 2020-03-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 45

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SHR-1210+ apatinib	SHR-1210	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
SHR-1210+ apatinib	apatinib	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

Primary Outcome Measures

Name	Time	Method
relapse-free survival(RFS)	1 year	from the date of enrollment to tumor recurrence or Death
Overall survival(OS)	3 years	the date of Death of any causes since the date of enrollment

Trial Locations

Locations (1)

Zhongshan Hospital; 🇨🇳 Shanghai, Shanghai, China