Clinical Trials /

Anlotinib Combined With TACE in Hepatocellular Carcinoma Patients at High Risk of Post Surgery Recurrence

NCT04213118

Description:

A single-arm, open-label clinical trial to assess the effects and safety of anlotinib hydrochloride combined with transcatheter arterial chemoembolization (TACE) in hepatocellular carcinoma(HCC) patients at high risk of post surgery recurrence.

Related Conditions:
  • Hepatocellular Carcinoma
Recruiting Status:

Not yet recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Anlotinib Combined With TACE in Hepatocellular Carcinoma Patients at High Risk of Post Surgery Recurrence
  • Official Title: An Open, Single Arm,Multicenter Clinical Trial of Anlotinib Combined With Transcatheter Arterial Chemoembolization for Adjuvant Therapy in Patients With High Risk of Recurrence After Resection of Advanced Hepatocellular Carcinoma

Clinical Trial IDs

  • ORG STUDY ID: KYLLSL-2019-185
  • NCT ID: NCT04213118

Conditions

  • Hepatocellular Carcinoma
  • TACE
  • Anlotinib

Interventions

DrugSynonymsArms
Anlotinib HydrochlorideGroup A

Purpose

A single-arm, open-label clinical trial to assess the effects and safety of anlotinib hydrochloride combined with transcatheter arterial chemoembolization (TACE) in hepatocellular carcinoma(HCC) patients at high risk of post surgery recurrence.

Detailed Description

      Hepatocellular carcinoma is one of the most common malignant tumors in the world with high
      incidence and mortality. Recurrence of HCC is still a great challenge and threat to the
      patients after resection surgery. Anlotinib is a new, orally administered tyrosine kinase
      inhibitor that targets vascular endothelial growth factor receptor (VEGFR), fibroblast growth
      factor receptor (FGFR), platelet-derived growth factor receptors (PDGFR), and c-kit.

      HCC patients who meet the eligibility criteria of this clinical trial will adopt
      postoperative TACE combined with anlotinib hydrochloride. At Day4 of TACE,anlotinib 12mg QD
      PO d1-14, 21 days per cycle until disease progresses or intolerant.

      Primary Efficacy Endpoint: Disease free survival (DFS);Secondary Efficacy Endpoints: 1-year
      DFS Rate and Time to recurrence (TTR)(According to RECIST Version 1.1).Safety will be
      evaluated by incidence, severity and outcomes of AEs and categorized by severity in
      accordance with the NCI CTC AE Version 4.0.
    

Trial Arms

NameTypeDescriptionInterventions
Group AExperimentalAdministration anlotinib and it should be continued until relapse of HCC or intolerable toxicity or patients withdrawal of consent.
  • Anlotinib Hydrochloride

Eligibility Criteria

        Inclusion Criteria:

          -  Patients participate in the study voluntarily and sign informed consent with good
             compliance.

          -  After hepatectomy, satisfy any of the following recurrence factors was assessed:≥5 cm
             and < 10 cm of tumor diameter; tumor number≥3; tumor microvascular invasion grade M1;
             portal vein carcinoma thrombus resection(Ⅰ、Ⅱ).

          -  Histological or cytological confirmation of hepatocellular carcinoma, or at least two
             imaging tests with hepatocellular carcinoma characteristics, or one imaging test with
             hepatocellular carcinoma characteristics and AFP > 400μg/L.

          -  TACE treatment (cTACE only) was completed within 1-2 months after hepatectomy.

          -  ≥ 18 and ≤ 75 years of age.

          -  ECOG performance status of 0-1.

          -  liver function child-Pugh class A or B (≤7 points).

          -  Except for hepatectomy, no previous tumor-related treatment was received, and the
             remaining liver was assessed to have good liver function.

        Exclusion Criteria:

          -  Patients who have had or are currently complicated with other malignant tumors,or
             recurrent hepatocellular carcinoma (>10 mm)in baseline data or in TACE.

          -  Patients with absolute contraindications to TACE.

          -  Patients with HCV infection.

          -  Urine protein ≥ ++,and 24-hour urinary protein excretion>1.0 g confirmed.

          -  Pregnant or lactating women.

          -  Patients with mental illness.
      
Maximum Eligible Age:75 Years
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Disease free survival
Time Frame:From randomization to recurrence of HCC or death (up to 1year)
Safety Issue:
Description:The period from resection surgery to recurrence of HCC

Secondary Outcome Measures

Measure:1-year DFS Rate
Time Frame:From randomization to recurrence of HCC or death (up to 1year)
Safety Issue:
Description:One year ratio of DFS
Measure:Time to recurrence
Time Frame:From randomization to recurrence of HCC(up to 1year)
Safety Issue:
Description:The period from resection surgery to recurrence of HCC
Measure:Incidence of Treatment-Emergent Adverse Events Safety and Tolerability
Time Frame:Up to 30 day safety follow-up visit
Safety Issue:
Description:Any adverse effects occur during the use of anlotinib

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:First Affiliated Hospital Xi'an Jiaotong University

Last Updated

December 25, 2019