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The initial application of Anlotinib in liver transplantation patients of hepatocellular carcinoma beyond Milan criteria

The initial application of Anlotinib in liver transplantation patients of hepatocellular carcinoma beyond Milan criteria

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000035520
Enrollment
Unknown
Registered
2020-08-13
Start date
2021-10-01
Completion date
Unknown
Last updated
2020-08-17

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

Conditions

hepatocellular carcinoma

Interventions

Sponsors

Zhongshan Hospital affiliated to Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-75 years old; 2. Patients with hepatocellular carcinoma confirmed by pathological examination and who had received liver transplantation had no great vascular infiltration, no lymph node or extrahepatic metastasis. 3. Above Milan standard (Milan standard: diameter of single tumor nodule =1 /5ml peripheral blood, scoring patients at high risk; 4. Child-pugh liver function rating: Grade A or better Grade B (=90 g/L; ANC >=1.5x10^9/L; PLT >=75x10^9/L; (2) Biochemical examination: ALB >=28 g/L; ALT and AST< 5 ULN; TBIL <=2 ULN; Creatinine <=1 ULN; 8. Subjects voluntarily participate in this study, sign the informed consent form, have good compliance and cooperate with the follow-up.

Exclusion criteria

Exclusion criteria: 1. Pathological diagnosis was intrahepatic cholangiocarcinoma, mixed cell carcinoma or fibre-laminar cell carcinoma; 2. Previous or concurrent malignancies (except cured basal cell carcinoma of skin and carcinoma in situ of the cervix); 3. Patients with multiple factors affecting oral medication (such as inability to swallow, chronic diarrhea and intestinal obstruction); 4. In 6 months, the patient has experienced ANY ARTERiovenous thrombosis events, such as cerebrovascular accident (including temporary ischemic attack), deep vein thrombosis and pulmonary embolism; 5. History of gastrointestinal bleeding caused by severe gastroesophageal varices or clear tendency of gastrointestinal bleeding;Or definite tendency of gastrointestinal bleeding due to other causes, such as active ulcer, ulcerative colitis, etc.Fecal occult blood ++ or above, if +, gastroscopy is required; 6. any of the following coagulation abnormalities: prothrombin time (PT) > 16 s, activated partial thrombin time (APTT) > 43 s, thrombin time (TT) > 21 s, INR > 2, fibrinogen (FIB) =150 mmHg or diastolic pressure >=100 mmHg); Having grade I or above myocardial ischemia or infarction, arrhythmia (including QTc interval >=480ms) and grade I cardiac insufficiency;LVEF (left ventricular ejection fraction) 10 mmol/L; (4) urine routine indicated urinary protein >=++, and confirmed 24-hour quantitative urinary protein > 1.0g; 8. There is an unhealed wound, ulcer or fracture; 9. Persons who have a history of abuse of psychotropic substances and cannot be cured or have mental disorders; 10. A history of immunodeficiency, including HIV positive or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation; 11. According to the researcher's judgment, there are other patients who are not suitable for inclusion.

Design outcomes

Primary

MeasureTime frame
Adverse Effects Rate;Duration of medication;

Secondary

MeasureTime frame
Relapse-free survival time;Overall survival;

Countries

China

Contacts

Public ContactJian Sun

Zhongshan Hospital affiliated to Fudan University

sun.jian1@zs-hospital.sh.cn+86 13901886126

Outcome results

None listed

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