search
Back to results

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

Primary Purpose

Hepatocellular Carcinoma

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
SHR-1210
apatinib
Sponsored by
Shanghai Zhongshan Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Zhongshan HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SHR-1210+ apatinib

Arm Description

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

Outcomes

Primary Outcome Measures

relapse-free survival(RFS)
from the date of enrollment to tumor recurrence or Death
Overall survival(OS)
the date of Death of any causes since the date of enrollment

Secondary Outcome Measures

Full Information

First Posted
October 25, 2018
Last Updated
December 16, 2018
Sponsor
Shanghai Zhongshan Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT03722875
Brief Title
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

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Unknown status
Study Start Date
December 1, 2018 (Actual)
Primary Completion Date
March 1, 2019 (Anticipated)
Study Completion Date
March 1, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Zhongshan Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SHR-1210+ apatinib
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
SHR-1210
Other Intervention Name(s)
Anti-PD-1 Antibody
Intervention Description
SHR-1210 is a humanized anti-PD1 IgG4 monoclonal antibody.
Intervention Type
Drug
Intervention Name(s)
apatinib
Intervention Description
Apatinib is a selective VEGFR2 inhibitor
Primary Outcome Measure Information:
Title
relapse-free survival(RFS)
Description
from the date of enrollment to tumor recurrence or Death
Time Frame
1 year
Title
Overall survival(OS)
Description
the date of Death of any causes since the date of enrollment
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fan Jia, PHD
Phone
021 64041990/680774
Email
fan.jia@zs-hospital.sh.cn
Facility Information:
Facility Name
Zhongshan Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jia Fan
Email
fan.jia@zs-hospital.sh.cn

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

We'll reach out to this number within 24 hrs