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

NCT03945799 | Terminated Phase 1

• 1 other identifier: KY2019-AHR-ZJU
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

• Disease free survival

  The period from resection surgery to recurrence of HCC

  From randomization to recurrence of HCC or death (up to 1year)

Secondary Outcomes (2)

• Adverse effect

  Up to 1year

• Overall survival

  1 year

Study Arms (1)

Anlotinib

EXPERIMENTAL

Administration Anlotinib and it should be continued until relapse of HCC or intolerable toxicity or patients withdrawal of consent.

Drug: Anlotinib Hydrochloride

Interventions

Anlotinib Hydrochloride DRUG

Anlotinib: 12mg QD PO d1-14, 21 days per cycle, 8 cycles.

Anlotinib

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• No allergic history of Anlotinib
• 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. tumor number ≥ 3 D. preoperative rupture of tumor or tumor invasion adjacent organs
• Patients participate in the study voluntarily and sign informed consent

You may not qualify if:

• 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), FOLFOX systemic chemotherapy or huaier granules after surgery
• Urine protein ≥ ++，and 24-hour urinary protein excretion\>1.0 g confirmed

Sponsors & Collaborators

• Zhejiang University: lead
• Shulan (Hangzhou) Hospital: collaborator
• West China Hospital: collaborator
• Huashan Hospital: collaborator
• Third Affiliated Hospital, Sun Yat-Sen University: collaborator
• The First Affiliated Hospital of Zhengzhou University: collaborator
• The First Hospital of Jilin University: collaborator
• Tianjin First Central Hospital: collaborator
• Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine: collaborator

Study Sites (1)

The First Affiliated Hospital of Medical School of Zhejiang University

Hangzhou, Zhejiang, 310003, China

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: May 9, 2019
• First Posted: May 10, 2019
• Study Start: April 22, 2019
• Primary Completion: June 25, 2022
• Study Completion: June 25, 2022
• Last Updated: August 31, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)