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

• Status: Recruiting
• Trial end date: 2024-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

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

Criteria

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. tumor number >3 D. preoperative rupture of tumor or tumor invasion adjacent organs

• Patients participate in the study voluntarily and sign informed consent

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), FOLFOX systemic chemotherapy or huaier granules after surgery

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