Evaluate the Treatment With Sintilimab Injection Plus Endostar in Hepatocellular Carcinoma

NCT03881501 | Unknown

• 1 other identifier: TJCC009
• Study Type: observational
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatocellular Carcinoma Non-resectable

Keywords

Hepatocellular Carcinoma; Sintilimab Injection; Endostar

Outcome Measures

Primary Outcomes (2)

• ORR

  The rate of participants that achieve either a complete response (CR) or a partial response (PR).

  up to 3 years

• PFS

  From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first

  up to 3 years

Secondary Outcomes (3)

• OS

  up to 3 years

• DOR

  up to 3 years

• Safety as measured by number and grade of adverse events

  up to 3 years

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Untreated Locally Advanced or Metastatic Hepatocellular Carcinoma

You may qualify if:

• 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;
• HIV test results were negative at screening;
• Records of virological status of hepatitis, confirmed by serological tests of HBV and HCV;
• Patients with active hepatitis B virus (HBV) infection:HBV DNA \< 500 IU/mL was obtained within 28 days before the start of the study, and received at least 14 days of anti-HBV treatment (based on local standard treatment, such as entecavir) prior to the study, and was willing to continue treatment during the study period.

You may not qualify if:

• 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;
• Major surgical treatments (except diagnosis) were received within 4 weeks before the start of the study, or major surgical treatments were expected during the study period;
• Other malignant tumors were diagnosed within 5 years before the first administration. Exceptions included radical basal cell carcinoma, squamous cell carcinoma, adequately treated cervical cancer in situ, and localized prostate cancer;
• Active infections requiring systemic treatment;
• Fiberboard HCC, sarcomatoid HCC or mixed cholangiocarcinoma and HCC are known;
• Moderate or severe ascites;

Sponsors & Collaborators

• Huazhong University of Science and Technology: lead

Study Sites (1)

Tongji Hospital

Wuhan, Hubei, 430000, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Xianglin Yuan, MD,PhD

  Tongji Hospital

  STUDY CHAIR

Central Study Contacts

Xianglin Yuan, MD,PhD

CONTACT

8627-83663406; xlyuan1020@163.com

Yanmei Zou, MD,PhD

CONTACT

8627-83663406; zouyanmei0101@126.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Head of the cancer center

Study Record Dates

• First Submitted: March 14, 2019
• First Posted: March 19, 2019
• Study Start: March 5, 2019
• Primary Completion: March 1, 2020
• Study Completion: March 1, 2020
• Last Updated: March 19, 2019

Record last verified: 2019-03

Locations

CN (1)