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To assess the primary effects and safety of Anlotinib with placebo in patients with Hepatocellular Carcinoma(HCC).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anlotinib | Experimental | Anlotinib QD po and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anlotinib | Drug | Anlotinib p.o. qd |
|
| 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) |
| 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) |
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Inclusion Criteria:
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:
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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Aiping Zhou, doctor | Contact | zhouap1825@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Recruiting | Beijing | Beijing Municipality | 100021 | China |
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| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| C000625192 | anlotinib |
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| 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) |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |