A Multicenter Study of Anlotinib in Hepatocellular Carcinoma (HCC) Patients at High Risk of Post Surgery Recurrence

Last updated: August 25, 2022
Sponsor: Zhejiang University
Overall Status: Terminated

Phase

1/2

Condition

Cancer

Abdominal Cancer

Liver Cancer

Treatment

N/A

Clinical Study ID

NCT03945799
KY2019-AHR-ZJU
  • Ages 18-75
  • All Genders

Study Summary

To assess the primary effects and safety of Anlotinib in HCC patients at high risk of post surgery recurrence.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • No allergic history of Anlotinib
  • 18-75 years
  • No history of severe arrhythmia or heart failure
  • No history of severe ventilation dysfunction or severe pulmonary infection
  • No acute or chronic renal failure, creatinine clearance > 40 mL/min
  • Liver function is normal: child-pugh grade A or grade B (≤7 points), total bilirubin ≤ 3.0 mg/dL, albumin ≥ 28 g/L, AST, ALT, ALP≤ 5 times of the upper limit of normal value
  • Blood test: the absolute neutrophil count ≥ 1.5×10^9 /L, Hb ≥ 8.5 g/L, PLT ≥ 75×10^9 /L (without blood transfusions and drug therapy 14 days before the screening)
  • Blood coagulation function: INR≤2.3
  • ECOG: 0-2
  • Pathology: hepatocellular carcinoma
  • Satisfy any of the following: A. portal vein, hepatic vein or bile duct carcinoma thrombus B. microvascular invasion (MVI) grade II (> 5 MVI, or MVI occurs in the area more than 1 cm from the tumor) C. tumornumber ≥ 3 D. preoperative rupture of tumor or tumor invasion adjacent organs
  • Patients participate in the study voluntarily and sign informed consent

Exclusion

Exclusion Criteria:

  • Pregnant or lactating women
  • Patients who have had or are currently complicated with other malignant tumors
  • Recurrent hepatocellular carcinoma
  • Patients who participated in other clinical trials within 1 month
  • Patients with mental illness
  • Patients treated with targeted drugs, immunotherapy (such as PD1 antibody), FOLFOXsystemic chemotherapy or huaier granules after surgery
  • Urine protein ≥ ++,and 24-hour urinary protein excretion>1.0 g confirmed

Study Design

Total Participants: 28
Study Start date:
April 22, 2019
Estimated Completion Date:
June 25, 2022

Study 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 be administrated Anlotinib 12mg QD PO d1-14, 21 days per cycle. The disease free survival (DFS), overall survival (OS) and any adverse effect during the 8 cycles of Anlotinib treatment will be evaluated in order to assess the primary effects and safety of Anlotinib in HCC patients at high risk of post surgery recurrence.

Connect with a study center

  • The First Affiliated Hospital of Medical School of Zhejiang University

    Hangzhou, Zhejiang 310003
    China

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.