ATAHC: Anlotinib in the Treatment of Advanced Hepatocellular Carcinoma (HCC)
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Anlotinib Arm
|
Drug: Anlotinib
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.
|
Outcome Measures
Primary Outcome Measures
- PFS [3 month]
Progression free survival
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age: 18 to 75 years old.
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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.
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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.
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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.
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Child-Pugh liver function rating: grade A or B; BCLC stage B or C.
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ECOG PS：0-2.
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The life expectancy is more than 12 weeks.
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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)
- 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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Hepatobiliary and mixed cell carcinomas and fiberboard cell carcinomas are known; other malignant tumors (except cured cutaneous basal cell carcinomas and cervical carcinoma in situ) have been reported in the past or at the same time.
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Pregnant or lactating women .
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Patients with hypertension who could not be well controlled by antihypertensive drugs (systolic blood pressure > 150 mmHg, diastolic blood pressure > 100 mmHg), patients with myocardial ischemia or myocardial infarction above grade II, arrhythmias with poor control (including QTC interval > 450 ms) and cardiac insufficiency of grade III-IV according to NYHA standard.
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Inability to swallow, chronic diarrhea and intestinal obstruction significantly affect drug use and absorption.
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There are clear concerns about gastrointestinal bleeding (such as local active ulcer lesions, fecal occult blood +) or more), and there is a history of gastrointestinal bleeding within 6 months.
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Central nervous system metastasis has occurred.
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Coagulation dysfunction (PT > 16 s, APTT > 43 s, TT > 21 s, Fbg < 2 g/L), with bleeding tendency or undergoing thrombolysis or anticoagulation therapy.
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Have a history of mental illness or psychotropic drug abuse.
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Peritoneal effusion with clinical symptoms requires therapeutic abdominal puncture or drainage, or Child-Pugh score (> 2).
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- The First Affiliated Hospital with Nanjing Medical University
Investigators
- Study Chair: Yongqian Shu, PhD, JANGSU PROVINCE HOSPITAL
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2018-SR-273