RecruitingPhase 3NCT06841172

Continuation of First-line Therapy With Radiotherapy Versus Early Switch to Second-line Therapy in Oligoprogressive HCC

Continuation of First-line Therapy With Radiotherapy for Oligoprogression Versus Early Switch to Second-line Therapy in Oligoprogressive Hepatocellular Carcinoma (CROSS): a Multi-center, Randomized, Controlled, Open-label, Phase Ⅲ Trial


Sponsor

Shandong Cancer Hospital and Institute

Enrollment

132 participants

Start Date

Jul 21, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This multicenter, prospective, randomized, controlled, open-label, two-arm Phase III clinical trial is designed to evaluate whether adding radiotherapy to oligoprogressive lesions while continuing first-line systemic therapy at the time of oligoprogression can effectively prolong progression-free survival compared to early switching to second-line systemic therapy in oligoprogressive hepatocellular carcinoma.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether, for people with liver cancer (hepatocellular carcinoma, or HCC) whose disease is growing in only a few spots (called oligoprogression) while on first-line treatment, it's better to add targeted radiation to those spots versus switching to a new drug regimen entirely. **You may be eligible if...** - You have been diagnosed with primary liver cancer (HCC) at an advanced stage (BCLC stage C) - You are on a first-line systemic treatment and only 1–5 specific spots are growing while others remain stable - The growing spots can safely be treated with radiation **You may NOT be eligible if...** - Your cancer is spreading widely (more than 5 sites or more than 3 organs) - You cannot safely receive radiation to the progressing spots - You have serious liver dysfunction or organ failure - 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

RADIATIONradiotherapy

Radiotherapy (Biologically Equivalent Dose \[BED\]≥60Gy)

DRUGSystemic therapy (Continuation of current first-line systemic therapy)

Continuation of current first-line systemic therapy, which may include, but is not limited to, combinations such as atezolizumab plus bevacizumab, tremelimumab plus durvalumab, or monotherapies such as lenvatinib, sorafenib, tislelizumab, durvalumab, or pembrolizumab, at the discretion of the treating physician.

DRUGSystemic therapy (Early switch to second-line systemic therapy)

For patients who received sorafenib as FLST, regorafenib will be the preferred second-line option. For patients who received other FLST regimens, the SLST selection will be determined through an MDT discussion led by the treating physician based on the patient's overall condition, prior therapies, drug indications, and potential adverse effects, ensuring an individualized treatment approach. The specific dosing regimen, administration frequency, and dose adjustments will strictly follow the same prescribing information for each drug.


Locations(1)

Jinan, Shandong 0531

Jinan, Shandong, China

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NCT06841172


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