TACE Combined With Lenvatinib and PD-1 Inhibitor for Ruptured Hepatocellular Carcinoma
Launched by SUN YAT-SEN UNIVERSITY · Dec 13, 2024
Trial Information
Current as of July 12, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is looking at a new treatment approach for patients with a specific type of liver cancer called hepatocellular carcinoma (HCC) that has ruptured, causing bleeding. The study is exploring how well a combination of three treatments—transcatheter arterial chemoembolization (TACE), Lenvatinib, and a PD-1 inhibitor—can help control the cancer and improve patients' outcomes. TACE is a procedure that helps stop the bleeding and shrink the tumor, while Lenvatinib and the PD-1 inhibitor are medications that aim to fight the cancer cells more effectively.
To participate in this trial, individuals must be diagnosed with HCC and have certain criteria, such as having a specific level of liver function and a life expectancy of at least three months. The trial is open to adults aged 18 to 75 who have not had any other cancers and do not have recurrent or non-ruptured HCC. Participants can expect to receive these treatments as part of their care, and they will be monitored closely throughout the study to assess how well the combination therapy works. This trial is currently recruiting participants, and it aims to provide new hope for those facing this challenging condition.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 1. diagnosis of primary HCC, confirmed histologically or clinically according to the criteria of the American Association for the Study of Liver Diseases;
- • 2. presence of hemostasis in the enhanced CT scan;
- • 3. integrity of the tumor is disrupted and there is hematoma around the liver;
- • 4. receipt of Lenvatinib and PD-1 inhibitor as the first-line systemic therapy;
- • 5. transarterial artery chemoembolization (TACE) as local therapy;
- • 6. classified as Child-Pugh class A or B and having an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 2;
- • 7. no history of other malignancies.
- • 8. life expectancy more than 3 months;
- • 9. agreed to participated in this clinical trial;
- • 10. Hemameba ≥3.0 x109/L, neutrophil ≥1.5x109/L, hemoglobin≥10.0 g/L, platelet≥100x 109/L, ALT; AST; bilirubin ≤1.5-fold normal, GFR≥60ml/min.
- Exclusion Criteria:
- • 1. recurrent HCC;
- • 2. non-ruptured HCC;
- • 3. Lenvatinib and PD-1 inhibitor treated with as second systemic therapy;
- • 4. age \< 18 years or \> 75 years;
- • 5. HCC with more than five metastases;
- • 6. History of hepatic encephalopathy and gastrointestinal bleeding
- • 7. life expectancy less than 3 months.
About Sun Yat Sen University
Sun Yat-sen University, a prestigious institution located in Guangzhou, China, is dedicated to advancing medical research and healthcare innovations. As a leading clinical trial sponsor, the university leverages its extensive academic resources and collaboration with top-tier medical professionals to conduct rigorous clinical studies. Committed to improving patient outcomes and contributing to global health knowledge, Sun Yat-sen University focuses on a wide range of therapeutic areas, employing cutting-edge methodologies to ensure the integrity and efficacy of its research initiatives. Through its clinical trials, the university aims to foster scientific advancements and enhance the quality of care provided to patients both locally and internationally.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Beijing, None Selected, China
Patients applied
Trial Officials
Feng Duan, MD
Study Director
Chinese PLA General Hospital
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported