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Anlotinib in the Treatment of Advanced Hepatocellular Carcinoma (HCC) (ATAHC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03766776
Recruitment Status : Unknown
Verified December 2018 by The First Affiliated Hospital with Nanjing Medical University.
Recruitment status was:  Not yet recruiting
First Posted : December 6, 2018
Last Update Posted : December 11, 2018
Sponsor:
Information provided by (Responsible Party):
The First Affiliated Hospital with Nanjing Medical University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Cancer of Liver Drug: Anlotinib Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Anlotinib Hydrochloride Capsules in the Treatment of Advanced Hepatocellular Carcinoma (HCC) Open, Single Arm, Exploratory Clinical Trial.
Estimated Study Start Date : December 31, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2020
Arms and Interventions
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Arm Intervention/treatment
Experimental: Anlotinib Arm Drug: Anlotinib
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.


Outcome Measures
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Primary Outcome Measures :
  1. PFS [ Time Frame: 3 month ]
    Progression free survival


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03766776


Contacts
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Contact: Yongqian Shu, PhD 0086-13813804568 shuyongqian@csco.org.cn

Sponsors and Collaborators
The First Affiliated Hospital with Nanjing Medical University
Investigators
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Study Chair: Yongqian Shu, PhD JANGSU PROVINCE HOSPITAL
More Information
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Responsible Party: The First Affiliated Hospital with Nanjing Medical University
ClinicalTrials.gov Identifier: NCT03766776    
Other Study ID Numbers: 2018-SR-273
First Posted: December 6, 2018    Key Record Dates
Last Update Posted: December 11, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma, Hepatocellular
Liver Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
 Adenocarcinoma
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases