Neoadjuvant treatment for resectable recurrent liver cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase II clinical trial investigates the efficacy and safety of Tislelizumab, a PD-1 inhibitor, and its combination with Lenvatinib as neoadjuvant treatment for patients with resectable recurrent hepatocellular carcinoma (RHCC). The trial aims to reduce tumor burden and recurrence rates after surgery by utilizing immune checkpoint inhibitors, which have shown promise in advanced HCC and early-stage solid tumors. Patients will be divided into two arms: one receiving Tislelizumab alone and the other receiving the combination therapy. The study is currently enrolling patients for the second arm after terminating the first due to modest responses.

Why it matters

Who can join: the full rules

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

Where it's running

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

Similar studies

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.