A Study of Anlotinib in Patients With Hepatocellular Carcinoma

• Status: Unknown status
• Trial end date: 2017-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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

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

Details

• Lead Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.; Jiangsu Chia-tai Tianqing Pharmaceutical Co.,Ltd

Criteria

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