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Evaluate the Treatment With Sintilimab Injection Plus Endostar in Hepatocellular Carcinoma

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ClinicalTrials.gov Identifier: NCT03881501
Recruitment Status : Recruiting
First Posted : March 19, 2019
Last Update Posted : March 19, 2019
Sponsor:
Information provided by (Responsible Party):
Xianglin Yuan, Huazhong University of Science and Technology

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.

Condition or disease
Hepatocellular Carcinoma Non-resectable

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.

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Study Type : Observational
Estimated Enrollment : 2 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: 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
Actual Study Start Date : March 5, 2019
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : March 2020



Primary Outcome Measures :
  1. ORR [ Time Frame: up to 3 years ]
    The rate of participants that achieve either a complete response (CR) or a partial response (PR).

  2. PFS [ Time Frame: up to 3 years ]
    From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first


Secondary Outcome Measures :
  1. OS [ Time Frame: up to 3 years ]
    Overall survival is defined as time from the start of treatment until death due to any reason.

  2. DOR [ Time Frame: up to 3 years ]
    The time between the first recorded and objective remission to the first onset of disease progression or all-cause death (whichever happens first)

  3. Safety as measured by number and grade of adverse events [ Time Frame: up to 3 years ]
    Summary adverse events according to NCI-CTCAE 4.03



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Untreated Locally Advanced or Metastatic Hepatocellular Carcinoma
Criteria

Inclusion Criteria:

  1. Able and willing to comply with the study plans in this protocol and sign the informed consent;
  2. Age of 18-75 years;
  3. Cytological or histological diagnosis of untreated locally advanced or metastatic hepatocellular carcinoma;
  4. Diseases are not suitable for radical surgery and/or local treatment, or disease progression occurs after surgery and/or local treatment;
  5. At least one measurable lesion as defined by RECIST 1.1 criteria and untreated lesion;
  6. 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;
  7. ECOG performance status of 0-1;
  8. Child-Pugh A;
  9. Bone marrow function: absolute neutrophil count(ANC) ≥1.5×109 /L, platelet count(PLT) ≥75×109 /L, hemoglobin(HB) ≥90 g/L;
  10. 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;
  11. HIV test results were negative at screening;
  12. Records of virological status of hepatitis, confirmed by serological tests of HBV and HCV;
  13. 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.

Exclusion Criteria:

  1. Systemic HCC treatment has been received in the past;
  2. History of primary immunodeficiency is known;
  3. It is known to have active tuberculosis;
  4. History of allogeneic organ transplantation and hematopoietic stem cell transplantation is known;
  5. It is known that there is a history of human immunodeficiency virus (HIV) infection (that is, HIV antibody positive);
  6. Severe allergic/allergic reactions to humanized antibodies or fusion proteins were observed;
  7. It is known to have hypersensitivity to any component contained in Endor preparations;
  8. Initial serious heart disease patients include congestive heart failure, uncontrollable high-risk arrhythmia, unstable angina pectoris, myocardial infarction, severe valvular disease and refractory hypertension;
  9. History of PIA meningitis;
  10. 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;
  11. 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;
  12. 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;
  13. Active infections requiring systemic treatment;
  14. Fiberboard HCC, sarcomatoid HCC or mixed cholangiocarcinoma and HCC are known;
  15. Moderate or severe ascites;
  16. History of hepatic encephalopathy;
  17. Patients with a history of HCV infection but negative results of HCV RNA PCR may consider that they are not infected with HCV;
  18. Systemic glucocorticoid therapy or any other form of immunosuppressive therapy is being administered within 7 days prior to the diagnosis of immunodeficiency or the study's first administration; physiological doses of glucocorticoid (<10mg/day prednisone or equivalent) are allowed.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03881501


Contacts
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Contact: Xianglin Yuan, MD,PhD 8627-83663406 xlyuan1020@163.com
Contact: Yanmei Zou, MD,PhD 8627-83663406 zouyanmei0101@126.com

Locations
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China, Hubei
Tongji Hospital Recruiting
Wuhan, Hubei, China, 430000
Contact: Xianglin Yuan, MD,PHD    8627-83663406    xlyuan1020@163.com   
Contact: Yanmei Zou, MD,PHD    8627-83663406    zouyanmei0101@126.com   
Sponsors and Collaborators
Huazhong University of Science and Technology
Investigators
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Study Chair: Xianglin Yuan, MD,PhD Tongji Hospital

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Responsible Party: Xianglin Yuan, Professor, Head of the cancer center, Huazhong University of Science and Technology
ClinicalTrials.gov Identifier: NCT03881501     History of Changes
Other Study ID Numbers: TJCC009
First Posted: March 19, 2019    Key Record Dates
Last Update Posted: March 19, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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

Keywords provided by Xianglin Yuan, Huazhong University of Science and Technology:
Hepatocellular Carcinoma
Sintilimab Injection
Endostar

Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Endostar protein
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents