Clinical trial NCT03766776: Anlotinib in the Treatment of Advanced Hepatocellular Carcinoma (HCC)
Official title: Anlotinib Hydrochloride Capsules in the Treatment of Advanced Hepatocellular Carcinoma (HCC) Open, Single Arm, Exploratory Clinical Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cancer of Liver
Lead sponsor: The First Affiliated Hospital with Nanjing Medical University
Sponsor class: OTHER
First posted: 2018-12-06
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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).

Primary outcomes:
measure: PFS
timeFrame: 3 month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: JANGSU PROVINCE HOSPITAL
name: Yongqian Shu, PhD
role: STUDY_CHAIR
References: