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Search / Trial NCT06644430

Ablation of Pulmonary Oligometastasis Combined With System for Advanced Hepatocellular Carcinoma

Launched by SUN YAT-SEN UNIVERSITY · Oct 15, 2024

Trial Information

Current as of July 24, 2025

Recruiting

Keywords

Advanced Hepatocellular Carcinoma Lenvatinib Sorafeinib Camrelizumab Tislelizumab Sintilimab Toripalimab Apatinib

ClinConnect Summary

This clinical trial is exploring a treatment option for patients with advanced liver cancer (hepatocellular carcinoma) that has spread to the lungs (known as pulmonary oligometastasis). The study aims to find out if a procedure called ablation, which destroys cancer cells in the lungs, can be safely combined with other therapies for better outcomes. This treatment is still relatively new for this type of cancer, and the trial seeks to gather more evidence on its effectiveness.

To be eligible for this trial, participants should be between 18 and 75 years old and have a confirmed diagnosis of liver cancer with limited lung metastases. They should have received at least three months of initial treatment for their liver cancer and have stable tumors. Other important criteria include having a good overall health status and no other active cancers. Participants who join the trial will undergo the ablation procedure and will be closely monitored for their health and cancer response. If you're interested in this trial, it could be a valuable opportunity to contribute to new cancer treatments while receiving care.

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 pulmonary oligometastasis, the metastases found within three month of HCC diagnosis;
  • 3. metastases with limited five sites and no more two organs involved, with a maximum diameter of ≤5cm;
  • 4. receipt of first-line systemic therapy for minimum of 3 months before ablation, with controlled intrahepatic tumors and no progression of metastases. Controlled intrahepatic tumors were defined as those showing a partial or stable response according to the modified Response Evaluation Criteria in Solid Tumors (mRECIST);
  • 5. undergone locoregional treatments, including transarterial artery chemoembolization (TACE) or hepatic arterial infusion chemotherapy (HAIC) were included;
  • 6. classified as Child-Pugh class A or B and having an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
  • 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. intermediate HCC;
  • 2. age \< 18 years or \> 75 years;
  • 3. advanced HCC with more than five metastases;
  • 4. no response to Lenvatinib;
  • 5. metastases size \> 5 cm;
  • 6. 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.

Locations

Beijing, Beijing, China

Patients applied

0 patients applied

Trial Officials

Feng Duan, MD

Study Director

Chinese PLA General Hospital

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported