Status:
UNKNOWN
Anlotinib in the Treatment of Advanced Hepatocellular Carcinoma (HCC)
Lead Sponsor:
The First Affiliated Hospital with Nanjing Medical University
Conditions:
Cancer of Liver
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
This is a prospective, one-arm, exploratory clinical study to observe and evaluate the efficacy and safety of Anlotinib hydrochloride capsules in patients with advanced liver cancer.
Eligibility Criteria
Inclusion
- Age: 18 to 75 years old.
- 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 PS：0-2.
- The life expectancy is more than 12 weeks.
- The main organs are functioning normally, which meets the following criteria:
- (1) Blood routine examination: A. HB \> 90 g/L; (No blood transfusion within 14 days) B. ANC is more than 1.5 x /L; C. PLT is more than 50 x /L; (2) Biochemical examination: A. ALT and AST \< 5\_ULN; B. TBIL \< 1.5\_ULN; C. Plasma Cr \< 1.5\_ULN.
- Subjects volunteered to join the study, signed informed consent, good compliance, with follow-up.
Exclusion
- 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.
- Central nervous system metastasis has occurred.
- 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 Child-Pugh score (\> 2).
Key Trial Info
Start Date :
December 31 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2020
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT03766776
Start Date
December 31 2018
End Date
December 31 2020
Last Update
December 11 2018
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