Anlotinib in the Treatment of Advanced Hepatocellular Carcinoma (HCC) (ATAHC)
Primary Purpose
Cancer of Liver
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Anlotinib
Sponsored by
About this trial
This is an interventional treatment trial for Cancer of Liver
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).
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Anlotinib Arm
Arm Description
Outcomes
Primary Outcome Measures
PFS
Progression free survival
Secondary Outcome Measures
Full Information
NCT ID
NCT03766776
First Posted
December 5, 2018
Last Updated
December 9, 2018
Sponsor
The First Affiliated Hospital with Nanjing Medical University
1. Study Identification
Unique Protocol Identification Number
NCT03766776
Brief Title
Anlotinib in the Treatment of Advanced Hepatocellular Carcinoma (HCC)
Acronym
ATAHC
Official Title
Anlotinib Hydrochloride Capsules in the Treatment of Advanced Hepatocellular Carcinoma (HCC) Open, Single Arm, Exploratory Clinical Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
December 2018
Overall Recruitment Status
Unknown status
Study Start Date
December 31, 2018 (Anticipated)
Primary Completion Date
December 31, 2019 (Anticipated)
Study Completion Date
December 31, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The First Affiliated Hospital with Nanjing Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer of Liver
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Anlotinib Arm
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Anlotinib
Intervention Description
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.
Primary Outcome Measure Information:
Title
PFS
Description
Progression free survival
Time Frame
3 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yongqian Shu, PhD
Phone
0086-13813804568
Email
shuyongqian@csco.org.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yongqian Shu, PhD
Organizational Affiliation
JANGSU PROVINCE HOSPITAL
Official's Role
Study Chair
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Anlotinib in the Treatment of Advanced Hepatocellular Carcinoma (HCC)
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