Search / Trial NCT06232759

TACE Combined With Tyrosine Kinase Inhibitors and Tislelizumab in Unresectable Hepatocellular Carcinoma

Launched by GUANGXI MEDICAL UNIVERSITY · Jan 22, 2024

Trial Information

Current as of October 03, 2024

Completed

Keywords

Hepatocellular Carcinoma

Description

No description provided

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • * Had Child-Pugh score 5-7 liver function, an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, and adequate organ function at the time of treatment initiation;
  • * With stage Ⅰb, Ⅱa, Ⅱb or Ⅲa hepatocellular carcinoma (HCC) based on the Chinese liver Cancer Staging System (CNLC);
  • * With unresectable HCC because of insufficient residual liver volume;
  • * Expected survival time ≥6 months;
  • * Hematology indexes should meet the following conditions: hemoglobin ≥90 g/L; platelet ≥80; total bilirubin ≤1.5×ULN; alanine transaminase ≤3×ULN; aspertate aminotransferase ≤ 3 x ULN; alkaline phosphatase ≤2.5×ULN; serum albumin ≥28 g/L; serum creatinine ≤1.5×ULN;
  • * Urinary protein \<2+ or 24 h urinary protein quantity \< 1.0g;
  • * For women of reproductive age, contraceptive measures (such as intrauterine devices, contraceptive tablets or condoms) are required during the clinical trial until 120 days after the end of the clinical trial; Women of childbearing age had negative serum or urine HCG test results within 7 days prior to inclusion in the study; For male patients whose partners have reproductive potential, effective contraception should be used during the study period and for 120 days after the end of the study.
  • Exclusion Criteria:
  • * Combined with other malignant tumors;
  • * Previously received local treatment of HCC such as Hepatic Artery Infusion Chemotherapy, transarterial (chemo)embolization, or local ablation;
  • * Those who have received or are using one of the following three types of drugs in the past 6 months: Immune checkpoint inhibitors, including but not limited to Atezolizumab, Nivolumab, pembrolizumab, Camrelizumab, Tislelizumab, triplizumab, sintilimab, etc.; Molecular targeted therapy, including but not limited to sorafenib, lenvatinib, donafenib, apatinib, regorafenib, anrotinib, bevacizumab, etc.; systemic chemotherapy drugs (such as doxorubicin, oxaliplatin, 5-FU, S-1, etc.);
  • * The presence of congenital or acquired immunodeficiency diseases (such as HIV positive);
  • * Active infection, or body temperature ≥ 38.5℃ 7 days before enrollment.

About Sponsor

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

Jennifer Cobb

Immunology at National Institute of Allergy and Infectious Diseases (NIAID)

Locations

Nanning, Guangxi, China

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0