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Status:

UNKNOWN

Anlotinib Hydrochloride Combined With Sintilimab Injection in the Treatment of Advanced Hepatocellular Carcinoma (HCC)

Lead Sponsor:

The First Affiliated Hospital with Nanjing Medical University

Conditions:

Advanced Hepatocellular Carcinoma

Eligibility:

All Genders

18-70 years

Phase:

PHASE2

Brief Summary

This is a single-arm, open-label and exploratory clinical study of Anlotinib Hydrochloride Capsules combined with Sintilimab injection in the treatment of advanced Hepatocellular Carcinoma (HCC). In ...

Detailed Description

This is a single-arm, open-label and exploratory clinical study of Anlotinib Hydrochloride Capsules combined with Sintilimab injection in the treatment of advanced Hepatocellular Carcinoma (HCC).In od...

Eligibility Criteria

Inclusion

  • Inclusion criteria:
  • At least one measurable lesion (the length of spiral CT scan (\> 10mm) meets the requirements of RESCIST 1.1) is found in patients with HCC confirmed by histopathology or cytology or who meet the clinical diagnostic criteria.
  • Inability or unwillingness to undergo surgery and transcatheter hepatic artery interventional therapy; if interventional therapy, radiotherapy or surgery has been accepted, it must be more than 4 weeks, and adverse reactions or wounds have fully recovered.
  • No treatment with sorafenib or other systemic treatment was received. Patients who have used interventional chemotherapeutic drugs during interventional therapy may be enrolled in the group.
  • Child-Pugh liver function rating: grade A or B; BCLC stage B or C.
  • ECOG 0-1
  • The life expectancy is more than 12 weeks.
  • The main organs are functioning normally.
  • Subjects volunteered to join the study, signed informed consent, good compliance, with follow-up.
  • Exclusion Criteria:
  • Hepatobiliary and mixed cell carcinomas and fiberboard cell carcinomas are known; other malignant tumors (except cured cutaneous basal cell carcinomas and cervical carcinoma in situ) have been reported in the past or at the same time.
  • Pregnant or lactating women.
  • Patients with hypertension who could not be well controlled by antihypertensive drugs (systolic blood pressure \> 150 mmHg, diastolic blood pressure \> 100 mmHg), patients with myocardial ischemia or myocardial infarction above grade II, arrhythmias with poor control (including QTC interval \> 450 ms) and cardiac insufficiency of grade III-IV according to NYHA standard.
  • Inability to swallow, chronic diarrhea and intestinal obstruction significantly affect drug use and absorption.
  • There are clear concerns about gastrointestinal bleeding (such as local active ulcer lesions, fecal occult blood ++) or more), and there is a history of gastrointestinal bleeding within 6 months.
  • Coagulation dysfunction (PT \> 16 s, APTT \> 43 s, TT \> 21 s, Fbg \< 2 g/L), with bleeding tendency or undergoing thrombolysis or anticoagulation therapy.
  • Have a history of mental illness or psychotropic drug abuse.
  • Peritoneal effusion with clinical symptoms requires therapeutic abdominal puncture or drainage. Or patients with hepatic encephalopathy as well as with liver transplantation.
  • Patients with cancer thrombus involving the main portal vein or inferior vena cava.
  • Patients with Infectious pneumonia, non-infectious pneumonia, interstitial pneumonia and other disease requiring corticosteroids.
  • A history of chronic autoimmune diseases, such as systemic lupus erythematosus.
  • Patients with a history of inflammatory bowel diseases such as ulcerative enteritis and crohn's disease. Or patients with a history of inflammatory chronic diarrheal diseases such as irritable bowel syndrome.
  • Patients with a history of sarcoidosis or tuberculosis.
  • Patients with active hepatitis b, c and HIV infection; HBVER who could controll HBV DNA\<500 copy/ml after antiviral treatment is allowed to be included.
  • Patients who are allergic to components of Sintilimab injection and anlotinib preparations, or have a history of severe allergic reactions to other monoclonal antibodies.
  • Having a history of psychotropic substance abuse and being unable to quit or having a mental disorder.
  • Patients with a history of immunodeficiency, or other acquired congenital immunodeficiency diseases, or a history of organ transplantation and hematopoietic stem cell transplantation.
  • First dose immunosuppressive drugs used in the first 4 weeks, not including the nasal spray, inhalation, or other ways of topical corticosteroids or physiological doses of systemic corticosteroids (no more than 10 mg/day prednisone or other equivalent dose glucocorticoids). But temporary use of glucocorticoids is permitted for the treatment of dyspnea symptoms of asthma, chronic obstructive pulmonary disease and other diseases.
  • Systemic immunostimulant therapy was administered within 4 weeks prior to first administration or planned during the study period. Or systemic immunostimulant therapy was received within 4 weeks.
  • According to the researchers' judgment, there are serious concomitant diseases that endanger patient safety or prevent patients from completing the study.
  • Drug combinations that have an effect on the metabolism of CYP3A.
  • Urinary protein 2+ or 24-hour urinary protein \>1g.
  • Central nervous system metastasis has occurred.

Exclusion

    Key Trial Info

    Start Date :

    June 10 2019

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ESTIMATED

    End Date :

    December 30 2021

    Estimated Enrollment :

    20 Patients enrolled

    Trial Details

    Trial ID

    NCT04052152

    Start Date

    June 10 2019

    End Date

    December 30 2021

    Last Update

    August 9 2019

    Active Locations (1)

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    Page 1 of 1 (1 locations)

    1

    Jiangsu Province Hospital

    Nanjing, Jiangsu, China, 210029