Cancer of Liver
Conditions
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.
Interventions
DRUGAnlotinib
Anlotinib capsules: dosage of 12 mg PO qd, 14 days, 7 days, 21 days for a cycle. The dosage was adjusted according to the adverse reactions of patients.
Sponsors
The First Affiliated Hospital with Nanjing Medical University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 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 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. * 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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PFS | 3 month | Progression free survival |
Contacts
Primary ContactYongqian Shu, PhD
Outcome results
None listed