RecruitingPhase 2NCT04615143

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


Sponsor

Sun Yat-sen University

Enrollment

80 participants

Start Date

Dec 1, 2020

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether immune therapy drugs (tislelizumab alone or combined with lenvatinib) given before surgery can help people with recurring liver cancer (hepatocellular carcinoma) that can still be surgically removed. The goal is to shrink the tumor before surgery and potentially improve long-term outcomes. **You may be eligible if...** - You have been diagnosed with recurrent liver cancer after a prior curative treatment - Your cancer is still considered surgically removable by your medical team - You have at least one measurable tumor lesion and have not received local treatment for it - You are in good enough health (ECOG 0–1, Child-Pugh score 5–7) - Your organ function is adequate **You may NOT be eligible if...** - Your cancer has spread outside the liver - You have previously received immunotherapy, chemoembolization, or systemic liver cancer treatments (except curative ablation) - You have a history of autoimmune disease or active stomach/esophageal bleeding - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTislelizumab

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.

DRUGTislelizumab 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

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NCT04615143


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