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

Status: Recruiting
Location: See location...
Intervention Type: Radiation
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
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• Obtain written informed consent before implementing any trial-related procedures.

• Male or female, aged 18 years or older, and 75 years or younger.

• Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0-1.

• Histological or cytological confirmation of primary hepatocellular carcinoma (HCC), or diagnosed according to the Clinical Diagnosis and Treatment Guidelines for Primary - Liver Cancer (2019 edition) issued by the National Health Commission of the People's Republic of China.

• Tumor staged as BCLC stage C; patients have ≤5 lesions (≤3 affected organs) with oligometastasis or oligoprogression.

• Liver function assessed by Child-Pugh score ≤7 points.

• Availability of tumor samples for biomarker assessment.

• Stable disease with systemic therapy for ≥3 months and an anticipated survival period of ≥6 months.

Locations
Other Locations
China
Jinbo Yue
RECRUITING
Jinan
Contact Information
Primary
jinbo yue, dorctor
yuejinbo@hotmail.com
+86053167626442
Backup
lei xu
Len.Xu@hotmail.com
+86053167626442
Time Frame
Start Date: 2024-03-01
Estimated Completion Date: 2026-01-01
Participants
Target number of participants: 36
Related Therapeutic Areas
Sponsors
Leads: Shandong Cancer Hospital and Institute

This content was sourced from clinicaltrials.gov

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