NCT03722875

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
45

participants targeted

Target at P25-P50 for not_applicable hepatocellular-carcinoma

Timeline
Completed

Started Dec 2018

Shorter than P25 for not_applicable hepatocellular-carcinoma

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 25, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 29, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

December 1, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2020

Completed
Last Updated

December 19, 2018

Status Verified

October 1, 2018

Enrollment Period

3 months

First QC Date

October 25, 2018

Last Update Submit

December 16, 2018

Conditions

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (2)

  • relapse-free survival(RFS)

    from the date of enrollment to tumor recurrence or Death

    1 year

  • Overall survival(OS)

    the date of Death of any causes since the date of enrollment

    3 years

Study Arms (1)

SHR-1210+ apatinib

EXPERIMENTAL

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

Drug: SHR-1210Drug: apatinib

Interventions

SHR-1210DRUG

SHR-1210 is a humanized anti-PD1 IgG4 monoclonal antibody.

Also known as: Anti-PD-1 Antibody
SHR-1210+ apatinib
apatinibDRUG

Apatinib is a selective VEGFR2 inhibitor

SHR-1210+ apatinib

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongshan Hospital

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

camrelizumabspartalizumabapatinib

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Central Study Contacts

Fan Jia, PHD

CONTACT

021 64041990/680774fan.jia@zs-hospital.sh.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 25, 2018

First Posted

October 29, 2018

Study Start

December 1, 2018

Primary Completion

March 1, 2019

Study Completion

March 1, 2020

Last Updated

December 19, 2018

Record last verified: 2018-10

Locations

CN(1)