Neoadjuvant treatment for resectable recurrent liver cancer
Tislelizumab or Tislelizumab Combined With Lenvatinib Neo-adjuvant Treatment for Resectable Recurrent Hepatocellular Carcinoma：Phase II Non-randomized Control Clinical Trial
This study is testing if a new combination of immune therapy and medication can help people with resectable recurrent liver cancer have better outcomes after surgery.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Sun Yat-sen University Academic / other |
| Drugs / interventions | Tislelizumab, Lenvatinib |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT04615143 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are patients diagnosed with recurrent hepatocellular carcinoma who meet the criteria for resectability and have not received prior local treatment.
Not a fit: Patients with extrahepatic metastasis or those who have previously undergone certain liver cancer treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve surgical outcomes and reduce recurrence rates for patients with resectable RHCC.
How similar studies have performed: Previous studies have shown success with immune checkpoint inhibitors in advanced HCC, suggesting potential effectiveness in this neoadjuvant setting, although this specific approach is still being explored.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Guangzhou, Guangdong
- The First Affiliated Hospital of Sun Yat-sen University — Guangzhou, Guangdong, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.