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This is a prospective, one-arm, exploratory clinical study to observe and evaluate the efficacy and safety of Anlotinib hydrochloride capsules in patients with advanced liver cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anlotinib Arm | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anlotinib | Drug | Anlotinib capsules: dosage of 12 mg PO qd, 14 days, 7 days, 21 days for a cycle. The dosage was adjusted according to the adverse reactions of patients. |
|
| Measure | Description | Time Frame |
|---|---|---|
| PFS | Progression free survival | 3 month |
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Inclusion Criteria:
Age: 18 to 75 years old.
At least one measurable lesion (the length of spiral CT scan (> 10mm) meets the requirements of RESCIST 1.1) is found in patients with HCC confirmed by histopathology or cytology or who meet the clinical diagnostic criteria.
Inability or unwillingness to undergo surgery and transcatheter hepatic artery interventional therapy; if interventional therapy, radiotherapy or surgery has been accepted, it must be more than 4 weeks, and adverse reactions or wounds have fully recovered.
No treatment with sorafenib or other systemic treatment was received. Patients who have used interventional chemotherapeutic drugs during interventional therapy may be enrolled in the group.
Child-Pugh liver function rating: grade A or B; BCLC stage B or C.
ECOG PS:0-2.
The life expectancy is more than 12 weeks.
The main organs are functioning normally, which meets the following criteria:
(1) Blood routine examination: A. HB > 90 g/L; (No blood transfusion within 14 days) B. ANC is more than 1.5 x /L; C. PLT is more than 50 x /L; (2) Biochemical examination: A. ALT and AST < 5_ULN; B. TBIL < 1.5_ULN; C. Plasma Cr < 1.5_ULN.
Subjects volunteered to join the study, signed informed consent, good compliance, with follow-up.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yongqian Shu, PhD | Contact | 0086-13813804568 | shuyongqian@csco.org.cn |
| Name | Affiliation | Role |
|---|---|---|
| Yongqian Shu, PhD | JANGSU PROVINCE HOSPITAL | Study Chair |
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| ID | Term |
|---|---|
| D008113 | Liver Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| C000625192 | anlotinib |
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| D008107 |
| Liver Diseases |