Cadonilimab Plus Lenvatinib Combined with Stereotactic Body Radiotherapy for Conversion Therapy in Unresectable or...

Area of Science:

• Hepatocellular Carcinoma (HCC) Research
• Oncology
• Clinical Trials

Background:

• Conversion therapy for hepatocellular carcinoma (HCC) remains controversial, lacking standardized protocols.
• Advanced HCC treatments include immunotherapy and targeted therapy, showing significant antitumor activity.
• Radiotherapy, including stereotactic body radiotherapy (SBRT), shows promise in making unresectable HCC amenable to surgery.

Purpose of the Study:

• To evaluate the efficacy and safety of cadonilimab (dual immune checkpoint inhibitor) plus lenvatinib (tyrosine kinase inhibitor) combined with SBRT.
• To achieve conversion therapy for potentially resectable HCC, enabling surgical intervention.
• To prolong survival for unresectable HCC patients through a novel triple-combination regimen.

Main Methods:

• Single-arm, single-center exploratory cohort study enrolling 27 HCC patients.
• Treatment involves cadonilimab, lenvatinib, and SBRT.
• Tumor evaluation at baseline, post-cycle two, and preoperatively; postoperative follow-up every six weeks.
• Primary endpoint: Objective Response Rate (ORR) using RECIST v1.1 and mRECIST (mRECIST as primary).
• Secondary endpoints: surgical resection rate, MPR, DOR, DCR, PFS, TTP, OS, and adverse events (AEs) graded per NCI CTCAE v5.0.

Main Results:

• This section is not available in the provided abstract.
• Further details on objective response rate, surgical resection rate, and survival outcomes are pending study completion.

Conclusions:

• The study evaluates a novel triple-combination therapy (cadonilimab, lenvatinib, SBRT) for HCC conversion therapy.
• This regimen aims to leverage synergistic antitumor effects to address unmet needs in HCC treatment.
• Findings are expected to provide evidence for future large-scale randomized controlled trials.