A Study of Anlotinib in Patients With Hepatocellular Carcinoma

Study Overview
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Brief Summary
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To assess the primary effects and safety of Anlotinib with placebo in patients with Hepatocellular Carcinoma(HCC).

Official Title
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A Single Group, Open Label, Single-center Clinical Trial to Assess the Efficacy and Safety of Anlotinib in Patients With Hepatocellular Carcinoma (ALTER0802)

Conditions
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Hepatocellular Carcinoma

Intervention / Treatment
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* Drug: Anlotinib


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Conform to the clinical diagnosis standard strictly or histological or cytological confirmation of hepatocellular carcinoma who cannot benefit from treatments of ablative therapy Liver function status Child-Pugh Class A or B (score≤8) Enroll 2 group patients：Group A：No history of systematic chemotherapy/target therapy.Group B:Failed with Sorafenib(Last Sorafenib Therapy≥4 weeks ) Last Therapy≥4 weeks (such as surgery, PCI,ablation, radiotherapy)，and the wound healing.Patients with adjuvant chemotherapy, last chemotherapy ≥6m At least one measurable lesion (by RECIST1.1) 18-75 years,ECOG PS:0-1,Life expectancy of more than 3 months Main organs function is normal Women of childbearing potential should agree to use and utilize an adequate method of contraception (such as intrauterine device，contraceptive and condom) throughout treatment and for at least 6 months after study is stopped；the result of serum or urine pregnancy test should be negative within 7 days prior to study enrollment，and the patients required to be non-lactating；Man participants should agree to use and utilize an adequate method of contraception throughout treatment and for at least 6 months after study is stopped Patients should participate in the study voluntarily and sign informed consent Exclusion Criteria: Diagnosed with cholangiocellular carcinoma, mixed cell carcinoma and fibrolamellar hepatocellular carcinoma History of other malignancy (except for non-melanoma skin cancer, cervix in situ carcinoma) Liver function status Child-Pugh Class C (score>9),with malignant ascites HBV-DNA>2000IU/mL History of liver transplantation or prepare for it Patients with any severe and/or unable to control diseases，including： Blood pressure unable to be controlled ideally(systolic pressure≥150 mmHg，diastolic pressure≥100 mmHg); Patients with Grade 1 or higher myocardial ischemia, myocardial infarction or malignant arrhythmias(including QT≥480ms) and patients with Grade 1 or higher congestive heart failure (NYHA Classification); Patients with active or unable to control serious infections; Patients with poorly controlled diabetes (fasting blood glucose(FBG)>10mmol/L) Urine protein ≥ ++，and 24-hour urinary protein excretion>1.0 g confirmed Patients with arterial or venous thromboembolic events occurred within 6 months, such as cerebrovascular accident (including transient ischemic attack), deep vein thrombosis and pulmonary embolism Patients with drug abuse history and unable to get rid of or Patients with mental disorders Imaging showed tumors have involved important blood vessels or by investigators determine likely during the follow-up study and cause fatal hemorrhage Patients participated in other anticancer drug clinical trials within 4 weeks History of immunodeficiency Patients with concomitant diseases which could seriously endanger their own safety or could affect completion of the study according to investigators' judgment

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Anlotinib<br>Anlotinib QD po and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent | Drug: Anlotinib<br>* Anlotinib p.o. qd<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 12-week Progression-free survival rate(PFR 12w) |  | From randomization，each 42 days up to PD or death(up to 24 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Progression(TTP) |  | From randomization，each 42 days up to PD or death(up to 24 months) | 
| 24-week Progression-free survival rate(PFR 24w) |  | From randomization，each 42 days up to PD or death(up to 24 months) | 
| Serum Alpha-Fetoprotein level (AFP) |  | From randomization up to 24 months | 
| Overall Survival (OS) |  | From randomization until death (up to 24 months) | 
| Objective Response Rate (ORR) |  | each 42 days up to intolerance the toxicity or PD (up to 24 months) | 
| Disease Control Rate (DCR) |  | each 42 days up to intolerance the toxicity or PD (up to 24 months) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anlotinib, AL3818