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

Last updated: December 16, 2018
Sponsor: Shanghai Zhongshan Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Liver Disease

Liver Cancer

Hepatic Fibrosis

Treatment

N/A

Clinical Study ID

NCT03722875
ZSGY-PA-1809
  • Ages 18-75
  • All Genders

Study 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

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 notnormal, 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

Exclusion Criteria:

  1. No anti-tumor treatment for hepatocellular carcinoma, including chemotherapy andtopical treatment, before surgery.

  2. Known history of hypersensitivity to macromolecular protein preparation or anycomponents of the SHR- 1210 formulation.

  3. Tumors are not completely removed, or postoperative pathology suggestsnon-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 thefollowing: (1) > NYHA II congestive heart failure; (2) unstable angina, (3) myocardialinfarction within the past 1 year; (4) clinically significant supraventriculararrhythmia or ventricular arrhythmia requirement for treatment or intervention;

  6. Active infection or an unexplained fever > 38.5°C during screening or before the firstscheduled day of dosing (subjects with tumor fever may be enrolled at the discretionof 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

Total Participants: 45
Study Start date:
December 01, 2018
Estimated Completion Date:
March 01, 2020

Connect with a study center

  • Zhongshan Hospital

    Shanghai, Shanghai 200032
    China

    Active - Recruiting

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