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

Recruiting now · Phase 2

Conditions studied: Recurrent Hepatocellular Carcinoma

In brief

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

Key facts

Study ID

NCT04615143

Run by

Sun Yat-sen University

People needed

80

Starts

2020-12-01

Expected to finish

2027-12-01

Last updated by the study team

2025-01-09

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• The First Affiliated Hospital of Sun Yat-sen University — Guangzhou, Guangdong, China (enrolling)

Full record on ClinicalTrials.gov

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