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A prospective, open, single-arm, single-center clinical study on the treatment of advanced hepatocellular carcinoma with TACE combined with Anlotinib

A prospective, open, single-arm, single-center clinical study on the treatment of advanced hepatocellular carcinoma with TACE combined with Anlotinib

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1900024509
Enrollment
Unknown
Registered
2019-07-13
Start date
2019-08-01
Completion date
Unknown
Last updated
2019-07-22

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

Conditions

Advanced hepatocellular carcinoma

Interventions

Group 1:TACE combined with arotinib

Sponsors

Affiliated Tumor Hospital of Guangxi Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1.Patients aged 18 to 80 years with hepatocellular carcinoma have a pre-survival period of more than 12 weeks 2.Liver cancer lesions were consistent with BCLC stage B/C; 3.Child-pugh score of liver function =90 g/L (no blood transfusion within 14 days); b. ANC >=1.5x10^9 /L; c.PLT >= 80x10^9 /L; (2) Biochemical tests must meet the following criteria: a. TBIL 50 ml/min (Cockcroft-Gault formula). 6. Women of child-bearing age were willing to use appropriate methods of contraception during the trial and 8 weeks after the last administration of the trial drug If necessary, carry out early pregnancy examination before the test, and it should be negative; 7. Subjects volunteered to participate in this study, signing of informed consent, good complianceand, cooperate with the follow-up.

Exclusion criteria

Exclusion criteria: 1. Clinical evaluation of patients with contraindications to TACE surgery; 2. A patient who is preparing for a liver transplant; 3. Abnormal coagulation function(INR >1.5 or prothrombin time > ULN+4 S), have bleeding tendencies or are receiving thrombolytic or anticoagulant therapy; 4. Before enrolling, he was treated with targeted anti-angiogenic drugs such as Anlotinib; 5. The heart, lungs, kidneys, brain and other organs are seriously dysfunctional; 6. Peripheral blood white blood cells caused by chemotherapy drugs or other drugs 160 mmHg, Diastolic blood pressure > 100 mmHg). 13. Urine routine showed urinary protein >= ++ or confirmed 24-hour urine protein ration > 1.0g; 14. Pregnant or lactating women; 15. Mental illness, or a history of substance abuse.

Design outcomes

Primary

MeasureTime frame
Progression-free survival;

Secondary

MeasureTime frame
Objective response rate;Overall survival;Adverse reactions;

Countries

China

Contacts

Public ContactChang Zhao

Intervention Unit, Affiliated Tumor Hospital of Guangxi Medical University

258446483@qq.com+86 13768372540

Outcome results

None listed

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