At a glance
ClinicalIndex Comparison Record- ✓Histologically or cytologically confirmed HCC or diagnosis per 2024 China Clinical Guidelines
- ✓BCLC stage C at first-line systemic treatment initiation
- ✓Oligoprogression with 1-5 lesions in ≤3 organs confirmed by imaging or histopathology during FLST
- ✓Oligoprogression classified as repeat or induced per ESTRO-EORTC consensus
- ✕FLST received as adjuvant treatment after curative HCC surgery
- ✕Tumor progression within 3 months of FLST initiation
- ✕Combined hepatocellular-cholangiocarcinoma (cHCC-CC)
- ✕Grade ≥3 serious adverse events from prior FLST
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating radiotherapy, Systemic therapy (Continuation of current first-line systemic therapy), and 1 other intervention for OligoProgressive Metastatic Disease and 3 related conditions. Currently recruiting, targeting 132 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
Radiotherapy (Biologically Equivalent Dose \[BED\]≥60Gy)
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.
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.