Plain-English translation of NCT05608200 on ClinicalTrials.gov ↗ · Source last updated · Translation generated · How we translate trials
Phase 3 — Testing in thousands of people, comparing the treatment against what doctors currently use. This is the last big step before approval.
This study is testing whether adding a second medication called sintilimab to lenvatinib—along with a procedure called TACE that delivers chemotherapy directly to liver tumors—helps people with advanced liver cancer live longer than using lenvatinib with TACE alone. About 427 patients will be randomly assigned to receive either both medications plus the procedure, or just one medication plus the procedure. The study will track how long patients survive and how well the treatment controls their cancer.
Advanced liver cancer is difficult to treat and patients need more effective options. Doctors believe that combining two different types of medications—one that targets the tumor directly and one that boosts the immune system—might work better together than using just one medication with the procedure.
You likely qualify if…
You likely don't qualify if…
You will first receive a procedure called TACE, which delivers chemotherapy directly into your liver tumor through a catheter. Three to seven days later, you will start taking oral medication daily. Depending on which group you're randomly assigned to, you may also receive an intravenous infusion of the second medication every three weeks. You will have regular follow-up visits with blood tests and imaging scans to monitor how well the treatment is working and to check for side effects. The study will continue until your disease progresses, you experience side effects you cannot tolerate, or for up to 24 months, whichever comes first.
AI-generated summary from trial data · Jul 6, 2026 · Not medical advice
China
Phase
Large-scale testing
Sponsor
Second Affiliated Hospital of Guangzhou Medical University
Enrollment target
~427 participants
Started
November 2022
Primary completion
October 2026
Age range
18 Years – 75 Years
Last updated on clinicaltrials.gov in May 2023.
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Central contact
Mingyue Cai, MD
Second Affiliated Hospital of Guangzhou Medical University
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