Anlotinib in the Treatment of Advanced Hepatocellular Carcinoma (HCC)

Cancer of Liver Clinical Trial

— ATAHC  

Official title:

Anlotinib Hydrochloride Capsules in the Treatment of Advanced Hepatocellular Carcinoma (HCC) Open, Single Arm, Exploratory Clinical Trial.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03766776
• Other study ID #: 2018-SR-273
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 31, 2018
• Est. completion date: December 31, 2020

Study information

• Verified date: December 2018
• Source: The First Affiliated Hospital with Nanjing Medical University
• Contact: Yongqian Shu, PhD
• Phone: 0086-13813804568
• Email: shuyongqian[@]csco.org.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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:

• 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.

• Pregnant or lactating women .

• 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.

• Inability to swallow, chronic diarrhea and intestinal obstruction significantly affect drug use and absorption.

• 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.

• Central nervous system metastasis has occurred.

• Coagulation dysfunction (PT > 16 s, APTT > 43 s, TT > 21 s, Fbg < 2 g/L), with bleeding tendency or undergoing thrombolysis or anticoagulation therapy.

• Have a history of mental illness or psychotropic drug abuse.

• Peritoneal effusion with clinical symptoms requires therapeutic abdominal puncture or drainage, or Child-Pugh score (> 2).

Related Conditions & MeSH terms

• Cancer of Liver
• Carcinoma, Hepatocellular
• Liver Neoplasms

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital with Nanjing Medical University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PFS	Progression free survival	3 month