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

Hepatocellular Carcinoma Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03722875
• Other study ID #: ZSGY-PA-1809
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2018
• Est. completion date: March 1, 2020

Study information

• Verified date: October 2018
• Source: Shanghai Zhongshan Hospital
• Contact: Fan Jia, PHD
• Phone: 021 64041990/680774
• Email: fan.jia[@]zs-hospital.sh.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: March 1, 2020
• Est. primary completion date: March 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Drug:
• SHR-1210
SHR-1210 is a humanized anti-PD1 IgG4 monoclonal antibody.
• apatinib
Apatinib is a selective VEGFR2 inhibitor

Locations

Country	Name	City	State
China	Zhongshan Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Zhongshan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	relapse-free survival(RFS)	from the date of enrollment to tumor recurrence or Death	1 year
Primary	Overall survival(OS)	the date of Death of any causes since the date of enrollment	3 years