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An opening, single arm study of Apatinib in the treatment of advanced hepatocellular carcinoma

An opening, single arm study of Apatinib in the treatment of advanced hepatocellular carcinoma

Status
Recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-OPC-17011019
Enrollment
Unknown
Registered
2017-03-30
Start date
2017-03-01
Completion date
Unknown
Last updated
2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

hepatocellular carcinoma

Interventions

none:Apatinib

Sponsors

Huai'an First People's Hospital, Nanjing Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-75 years old; 2. The pathological diagnosis of hepatocellular carcinoma patients with measurable disease (measuring =10mm on spiral CT scan, satisfying the criteria in RECIST 1.1); 3. The patients are unable or not willing to treat surgery and via hepatic artery interventional therapy; 4. The Child-Pugh, classification standard: A/B, Barcelona Clinic Liver Cancer: B/C; 5. ECOG score 0-2; 6. The expected survival more than twelve weeks; 7. Subjects received interventional treatment, radiotherapy or surgery=4 weeks, and the adverse reaction or wound had completely healed; 8. The main organ function, that meet the following criteria: (1) subject to the standard blood test (14 days not blood transfusion and blood products): HB>=80 g/L; ANC>=1.5×10^9/L; PLT>=50×10^9/L; (2) biochemical tests must meet the following criteria: ALT and AST <5×ULN; TBIL <1.5×ULN; Cr<=1.5×ULN (One of the two indicators of albumin and bilirubin can be 2 points in child-pugh classification standard); 9. The subjects voluntarily joined the study, and informed consent, good compliance, with the follow-up.

Exclusion criteria

Exclusion criteria: 1. pregnant or lactating ; 2. After suffering from high blood pressure and antihypertensive medications can not fall within the normal range (systolic blood pressure> 140 mmHg, diastolic blood pressure> 90 mmHg) above the level of suffering I myocardial ischemia or myocardial infarction, arrhythmia (including QT interval of >=440 ms) and Class II heart failure; 3. obvious factors of oral drug absorption, such as inability to swallow, chronic diarrhea and intestinal obstruction; 4. Having definite gastrointestinal bleeding risk(such as local active ulcer lesions,fecal occult blood=++),history of gastrointestinal bleeding within 6 months.

Design outcomes

Primary

MeasureTime frame
PFS;

Countries

China

Contacts

Public ContactZhang Jianhuai

Jiangsu Hengrui Medicine Co., Ltd.

15996186060@qq.com+86 15996186060

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026