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Randomized controlled prospective trial for apatinib mesylate combined with TACE in the treatment of advanced hepatocellular carcinoma

Randomized controlled prospective trial for apatinib mesylate combined with TACE in the treatment of advanced hepatocellular carcinoma

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900020699
Enrollment
Unknown
Registered
2019-01-14
Start date
2018-01-01
Completion date
Unknown
Last updated
2019-01-28

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

Conditions

liver cancer

Interventions

one:TACE+Oral administration of apatinib at 500mg/ day
two:Only TACE

Sponsors

The First Affiliated Hospital of Nanchang University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) willing to sign the informed consent; (2) aged 18 to 75 years old male and female; (3) the primary liver cancer diagnosis standard: 1) have hepatitis b or hepatitis c, or have any reason to cause liver cirrhosis, at least every six months for an ultrasound and detection of AFP found intrahepatic diameter 2 cm or less nodules, dynamic enhanced MRI, dynamic enhanced CT and ultrasound imaging and the beauty show dynamic enhanced magnetic resonance imaging (MRI) at least two out of four examination showed arterial lesions significantly improved, portal or delay improved falling fast in fast out the typical characteristics of liver cancer, can make the clinical diagnosis of liver cancer; For nodules with > 2cm in diameter found in the liver, liver cancer can be clinically diagnosed as liver cancer as long as one of the four imaging examinations above has typical characteristics of liver cancer; 2) For patients with hepatitis b or hepatitis c, or liver cirrhosis caused by any reason, nodules with an diameter of 2cm in the liver can be found during follow-up. If none or only one of the four imaging examinations above has typical characteristics of liver cancer, liver biopsy or close imaging follow-up every 2-3 months can be conducted to establish the diagnosis; For the nodules with an intrahepatic diameter of > 2cm, the above four imaging examinations showed no typical characteristics of liver cancer, so liver biopsy was needed to establish the diagnosis; 3) With hepatitis b or hepatitis c, or any causes of cirrhosis of the liver, such as AFP, especially continues to increase, the four kinds of imaging examination should be performed to establish the diagnosis of liver cancer, such as not found intrahepatic nodules, beyond a pregnancy, active liver disease, reproductive embryonic origin above, under the premise of the digestive tract cancer tumor should be closely followed up the AFP levels and every 2-3 months once imaging review; (4) patients with primary liver cancer caused by various reasons, stage b-c of liver cancer BCLC.

Exclusion criteria

Exclusion criteria: (1) serum total bilirubin 44.5 mol/L (2) white blood cell count <1x10^9/L; (3) HIV infection; (4) patients with metastatic liver cancer; (5) patients with uncontrolled hypertension, diabetes or other serious heart and lung diseases; (6) pregnant and lactating women or women who do not exclude the possibility of pregnancy; (7) have participated in other drug trials within 3 months; (8) not suitable for participants.

Design outcomes

Primary

MeasureTime frame
Peripheral blood VEGF level;

Contacts

Public ContactGuo Guihai

The First Affiliated Hospital of Nanchang University

guoguihai@163.com+86 18079109652

Outcome results

None listed

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