Tislelizumab Neo-adjuvant Treatment for Resectable RHCC

• Status: Recruiting
• Trial end date: 2022-06-01
• Target enrollment: 0
• Participant gender: All

Summary

This single-arm phase II clinical trial aimed to explore the efficacy and safety of Tislelizumab as neoadjuvant treatment for resectable RHCC patients

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sun Yat-sen University

Criteria

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