Status:

UNKNOWN

Prevention and Treatment of Complications of Endovascular Methods in Patients With Malignant Liver Tumors

Lead Sponsor:

Central Clinical Hospital RZD-Medicine, Russian Federation

Conditions:

Hepatic Cancer

Metastatic Cancer

Eligibility:

All Genders

18+ years

Brief Summary

In the structure of malignant liver lesions, two main groups are distinguished - primary liver cancer and metastatic liver damage. The five-year survival rate of patients with malignant liver tumors d...

Eligibility Criteria

Inclusion

  • Aged over 18 years old;
  • Histologically confirmed diagnosis of liver cancer or metastatic liver disease;
  • Patients who have not received systemic antitumor therapy within the last 6 months

Exclusion

  • Metachronous (within 3 years) or synchronous other oncological disease with the exception of healed carcinoma in situ;
  • The volume of liver damage according to computed tomography is more than 60%;
  • Increase in the level of transaminases by more than 2 times;
  • The level of bilirubin is more than 50 μmol / l;
  • Heart failure stage II B-III, Functional Class III-IV;
  • The presence of uncorrected coagulopathy;
  • Renal failure stage III-IV;
  • Ascites 2-3 degrees;
  • The general condition of the patient is below 60% on the Karnofsky index and above 2 points on the Eastern Cooperative Oncology Group (ECOG) scale;
  • Liver damage - more than 7 points on the Child-Pugh scale;
  • Damage to the central nervous system;
  • Anemia of severe severity;
  • Pregnancy;
  • Active autoimmune disease;
  • Presence of HIV infection, active forms of tuberculosis;

Key Trial Info

Start Date :

January 12 2021

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

December 12 2023

Estimated Enrollment :

500 Patients enrolled

Trial Details

Trial ID

NCT04764409

Start Date

January 12 2021

End Date

December 12 2023

Last Update

February 21 2021

Active Locations (1)

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1

Central Clinical Hospital RZD-Medicine, Russian Federation

Moscow, Moscow's Oblast, Russia, 129128