A Single Arm, Observational Clinical Trial to Evaluate the Efficacy and Safety of Combination Treatment With Sintilimab Injection Plus Endostar in Untreated Locally Advanced or Metastatic Hepatocellular Carcinoma

Huazhong University of Science and Technology1 site in 1 country2 target enrollmentMarch 5, 2019

ConditionsHepatocellular Carcinoma Non-resectable

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Hepatocellular Carcinoma Non-resectable
Sponsor: Huazhong University of Science and Technology
Enrollment: 2
Locations: 1
Primary Endpoint: PFS
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

It is a a single arm, observational clinical trial to evaluate the efficacy and safety of combination treatment with sintilimab injection plus endostar in untreated locally advanced or metastatic hepatocellular carcinoma.

Detailed Description

For the first line treatment with untreated locally advanced or metastatic hepatocellular carcinoma, sintilimab injection plus endostar might be one of the treatment choices.

Registry

clinicaltrials.gov

Start Date

March 5, 2019

End Date

March 2020

Last Updated

7 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Huazhong University of Science and Technology

Responsible Party

Principal Investigator

Xianglin Yuan

Professor, Head of the cancer center

Huazhong University of Science and Technology

Eligibility Criteria

Inclusion Criteria

•Able and willing to comply with the study plans in this protocol and sign the informed consent;
•Age of 18-75 years;
•Cytological or histological diagnosis of untreated locally advanced or metastatic hepatocellular carcinoma;
•Diseases are not suitable for radical surgery and/or local treatment, or disease progression occurs after surgery and/or local treatment;
•At least one measurable lesion as defined by RECIST 1.1 criteria and untreated lesion;
•Patients who have received previous local treatment (e.g., radiofrequency ablation, ethanol or acetic acid injection, cryoablation, high intensity focused ultrasound, transcatheter arterial chemoembolization, transcatheter arterial embolization, etc.) are eligible to participate in the study if the target lesion has not received local treatment before, or if the target lesion within the scope of local treatment has subsequently developed on the basis of RECIST v1.1;
•ECOG performance status of 0-1;
•Child-Pugh A;
•Bone marrow function: absolute neutrophil count(ANC) ≥1.5×109 /L, platelet count(PLT) ≥75×109 /L, hemoglobin(HB) ≥90 g/L;
•alanine glutamate transaminase (ALT) and glutamate transaminase (AST) ≤5 x upper limit of normal range (ULN);total bilirubin (TBIL)≤3 x upper limit of normal range (ULN);Creatinine(Cr)≤1.5 x upper limit of normal range(ULN);Serum albumin (\> 28 g/L) (2.8 g/dL);Patients not receiving anticoagulation therapy: INR or aPTT \< 2 \*ULN;Urinary cellulose test paper results Proteinuria \< 2 (7 days before the start of treatment);Patients with baseline cellulose test paper urine test results (\> 2 proteinuria) should collect 24-hour urine, and then must confirm that the 24-hour urinary protein content is less than 1 g;

Exclusion Criteria

•Systemic HCC treatment has been received in the past;
•History of primary immunodeficiency is known;
•It is known to have active tuberculosis;
•History of allogeneic organ transplantation and hematopoietic stem cell transplantation is known;
•It is known that there is a history of human immunodeficiency virus (HIV) infection (that is, HIV antibody positive);
•Severe allergic/allergic reactions to humanized antibodies or fusion proteins were observed;
•It is known to have hypersensitivity to any component contained in Endor preparations;
•Initial serious heart disease patients include congestive heart failure, uncontrollable high-risk arrhythmia, unstable angina pectoris, myocardial infarction, severe valvular disease and refractory hypertension;
•History of PIA meningitis;
•Major cardiovascular diseases (e.g. New York Heart Association Grade II or more serious heart disease, myocardial infarction or cerebrovascular accident), unstable arrhythmia or unstable angina pectoris, occurred within three months before the start of treatment;