RecruitingNCT06261047

Radiotherapy Delays Second-line Drug Therapy for Oligo Progressive Primary Liver Cancer

Radiotherapy Delays Second-line Drug Therapy for Oligo Progressive Primary Liver Cancer: a Multicenter, Single-arm, Phase II Clinical Trial.


Sponsor

Shandong Cancer Hospital and Institute

Enrollment

36 participants

Start Date

Mar 1, 2024

Study Type

OBSERVATIONAL

Conditions

Summary

Recent years have seen significant advancements in the treatment landscape of advanced hepatocellular carcinoma (HCC), with the emergence of targeted and immunotherapy strategies reshaping first-line therapy. Sorafenib, a multi-targeted tyrosine kinase inhibitor, initially set the standard, followed by approvals for lenvatinib, regorafenib, cabozantinib, and ramucirumab. Immunotherapy, particularly combinations like atezolizumab with bevacizumab, has shown superior efficacy over sorafenib. Despite these advances, second-line therapies offer limited progression-free survival (mPFS: 2-3 months), necessitating new approaches. Radiotherapy, bolstered by technological advancements, has shown promise. Techniques like stereotactic body radiotherapy (SBRT) combined with PD-1 inhibitors achieve significant response rates and survival benefits. Combining radiotherapy with targeted immunotherapy has also demonstrated improved outcomes. Radiotherapy, especially in oligometastatic HCC, is increasingly favored due to its ability to enhance local control without increasing toxicity. These developments underscore the evolving landscape of HCC treatment towards personalized and multimodal approaches.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding targeted radiation therapy (radiotherapy) to a small number of progressing liver cancer lesions can delay the need to switch to a new systemic drug, thereby extending how long the current treatment continues to work. **You may be eligible if...** - You are between 18 and 75 years old - You have primary liver cancer (hepatocellular carcinoma, or HCC) - Your cancer is advanced stage (BCLC-C) with 5 or fewer lesions in up to 3 organs - Your liver function is reasonably preserved (Child-Pugh score ≤7) - Your current systemic therapy has kept the disease stable for at least 3 months - Your expected survival is at least 6 months - You are in good general health (ECOG score 0 or 1) **You may NOT be eligible if...** - You have another type of cancer (other than certain skin cancers treated and cured) - You are currently in another interventional clinical trial - You received radiation therapy within the last 2 weeks - You have HIV or active hepatitis B or C - You have active autoimmune disease requiring treatment 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

RADIATIONradiotherapy

radiotherapy


Locations(1)

Jinbo Yue

Jinan, Shandong, China

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NCT06261047


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