Last updated: August 25, 2022
Sponsor: Zhejiang University
Overall Status: Terminated
Phase
1/2
Condition
Cancer
Abdominal Cancer
Liver Cancer
Treatment
N/AClinical Study ID
NCT03945799
KY2019-AHR-ZJU
Ages 18-75 All Genders
Study Summary
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
Connect with a study center
The First Affiliated Hospital of Medical School of Zhejiang University
Hangzhou, Zhejiang 310003
ChinaSite Not Available

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