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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1
Jiangsu Province Hospital
Nanjing, Jiangsu, China, 210029