Tislelizumab or Tislelizumab Combined With Lenvatinib Neo-adjuvant Treatment for Resectable RHCC (TALENT)

  • STATUS
    Recruiting
  • End date
    Dec 1, 2025
  • participants needed
    80
  • sponsor
    Sun Yat-sen University
Updated on 19 April 2022

Summary

This non-randomized phase II clinical trial aimed to explore the efficacy and safety of Tislelizumab or Tislelizumab combined with Lenvatinib as neoadjuvant treatment for resectable RHCC patients

Description

Hepatocellular carcinoma (HCC) patients have about 70% of 5-year recurrence rate after curative treatment. Only 30% of recurrent HCC (RHCC) patients are resectable when diagnosed. Neoadjuvant treatment may reduce tumor burden and recurrence rate after surgery for RHCC patients. Immune checkpoint inhibitors combined with or without antiangiogenic agents have already been reported effective in advanced HCC patients as first-line therapy, and in several early-stage solid tumors as neoadjuvant therapy. According to several preclinical results, immune infiltration and the expression of PD-1 were higher in RHCC tumors than in paired primary tumors. So, immune checkpoint inhibitors combined with or without antiangiogenic agents might have a better response in RHCC patients than primary HCC patients. Herein, we designed this phase II clinical trial to explore the efficacy and safety of Tislelizumab (PD-1 inhibitor) or Tislelizumab combined with Lenvatinib as neoadjuvant treatment for resectable RHCC patients. Enrolled resectable RHCC patients will be divided into two non-randomized seperate arms, sequentially (arm 1: neoadjuvant tislelizumab; arm 2: neoadjuvant tislelizumab and lenvatinib). Each arm was estimated to enroll 40 patients. We have already enrolled 11 patients in arm 1, and determined to terminate the enrollment of arm 1 due to modest treatment responses. The enrollment of arm 2 is ongoing.

Details
Condition Recurrent Hepatocellular Carcinoma
Treatment tislelizumab, Tislelizumab combined with Levatinib
Clinical Study IdentifierNCT04615143
SponsorSun Yat-sen University
Last Modified on19 April 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Diagnosed as recurrent hepatocellular carcinoma after curative treatment
The criteria for resectability is met
Has at least one evaluable lesion according to the RECIST 1.1 standard and has not received local treatment
Eastern Cooperative Oncology Group score 0-1, Child-pugh score 5-7
Agree to biopsy and blood sample collection
Adequate organ and marrow function

Exclusion Criteria

Previously received any transarterial chemoembolization and immune therapy and other local or systemic liver cancer treatments, except for curative ablation
Extrahepatic metastasis
History of gastroesophageal varices or active cardia ulcers associated with a high risk of bleeding
History of autoimmune disease or need to take immunosuppressant drugs for a long time
History of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS)
Abnormal organ function
Clear my responses

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