A Study of Anlotinib in Patients With Hepatocellular Carcinoma (ALTER0802)

CTTQ

Status and phase

Unknown

Phase 2

Conditions

Hepatocellular Carcinoma

Treatments

Drug: Anlotinib

Study type

Interventional

Funder types

Industry

Identifiers

NCT02809534

ALTN-08-II

Details and patient eligibility

About

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

Enrollment

60 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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：
1. Blood pressure unable to be controlled ideally(systolic pressure≥150 mmHg，diastolic pressure≥100 mmHg);
2. 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);
3. Patients with active or unable to control serious infections;
4. Patients with poorly controlled diabetes (fasting blood glucose(FBG)>10mmol/L)
5. 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