Anlotinib in the Treatment of Advanced Hepatocellular Carcinoma (HCC)

NCT03766776 | Unknown

• 1 other identifier: 2018-SR-273
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cancer of Liver

Outcome Measures

Primary Outcomes (1)

• PFS

  Progression free survival

  3 month

Study Arms (1)

Anlotinib Arm

EXPERIMENTAL

Drug: Anlotinib

Interventions

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.

Anlotinib Arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead

MeSH Terms

Conditions

Liver Neoplasms

Interventions

anlotinib

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases

Study Officials

• Yongqian Shu, PhD

  JANGSU PROVINCE HOSPITAL

  STUDY CHAIR

Central Study Contacts

Yongqian Shu, PhD

CONTACT

0086-13813804568; shuyongqian@csco.org.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2018
• First Posted: December 6, 2018
• Study Start: December 31, 2018
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2020
• Last Updated: December 11, 2018

Record last verified: 2018-12