Skip to main content
TTrialFinder
TrialFinder is for informational purposes only and does not provide medical advice. Always talk to your doctor.
RECRUITINGPhase 2INTERVENTIONAL

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

Tislelizumab or Tislelizumab Combined With Lenvatinib Neo-adjuvant Treatment for Resectable Recurrent Hepatocellular Carcinoma:Phase II Non-randomized Control Clinical Trial

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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

Who May Be Eligible (Plain English)

Who May Qualify: 1. Diagnosed as recurrent hepatocellular carcinoma after curative treatment; 2. The criteria for resectability is met; 3. Has at least one evaluable lesion according to the RECIST 1.1 standard and has not received local treatment; 4. Eastern Cooperative Oncology Group score 0-1, Child-pugh score 5-7; 5. Agree to biopsy and blood sample collection; 6. Adequate organ and marrow function. Who Should NOT Join This Trial: 1. Previously received any transarterial chemoembolization and immune therapy and other local or systemic liver cancer treatments, except for curative ablation; 2. Extrahepatic metastasis; 3. History of gastroesophageal varices or active cardia ulcers associated with a high risk of bleeding; 4. History of autoimmune conditions (where your immune system attacks your own body) or need to take immunosuppressant drugs for a long time; 5. History of testing positive for human weakened immune system virus (HIV) or known acquired weakened immune system syndrome (AIDS); 6. Abnormal organ function Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: 1. Diagnosed as recurrent hepatocellular carcinoma after curative treatment; 2. The criteria for resectability is met; 3. Has at least one evaluable lesion according to the RECIST 1.1 standard and has not received local treatment; 4. Eastern Cooperative Oncology Group score 0-1, Child-pugh score 5-7; 5. Agree to biopsy and blood sample collection; 6. Adequate organ and marrow function. Exclusion Criteria: 1. Previously received any transarterial chemoembolization and immune therapy and other local or systemic liver cancer treatments, except for curative ablation; 2. Extrahepatic metastasis; 3. History of gastroesophageal varices or active cardia ulcers associated with a high risk of bleeding; 4. History of autoimmune disease or need to take immunosuppressant drugs for a long time; 5. History of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS); 6. Abnormal organ function

Treatments Being Tested

DRUG

Tislelizumab

Patients receive Tislelizumab on week 1 and week 4 (200mg, iv, q3w). After 2 cycles of Tislelizumab and evaluation of resectability, patients will receive surgery in 6 weeks after enrollment. Patients will receive Tislelizumab for 1 year (200mg, iv, q3w, 17 cycles) in 4-6 weeks after surgery.

DRUG

Tislelizumab combined with Levatinib

Patients receive Tislelizumab on week 1 and week 4 (200mg, iv, q3w); Lenvatinib from Day1 to Day 28 (8/12mg qd). After neoadjuvant treatment and evaluation of resectability, patients will receive surgery in 6weeks after enrollment. Patients will receive Tislelizumab combined with Lenvatinib for 1 year in 4-6 weeks after surgery.

Locations (1)

The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China