Tianjin Medical University Cancer Institute and Hospital has shed new light on treating advanced liver cancer with a novel combination therapy, offering hope to patients with large unresectable hepatocellular carcinoma.
The study explores the fusion of hepatic arterial infusion chemotherapy (HAIC) with donafenib and sintilimab, aiming to assess the regimen’s safety and effectiveness in those who have not undergone prior systemic treatments.
Methodology and Patient Selection
Between December 2021 and May 2023, 36 patients with histologically confirmed uHCC were enrolled in this prospective single-arm study. Treatment involved continuous administration of donafenib, sintilimab, and HAIC until disease progression or unacceptable toxicity emerged, with the primary focus on objective response rates.
Results and Clinical Implications
The combination therapy yielded an objective response rate of 58.3% based on RECIST 1.1 criteria and 80.6% using mRECIST guidelines. Disease control rates reached an impressive 94.4%, and the 24-month overall survival rate was recorded at 59.6%. Median event-free survival stood at 15.3 months.
• Half of the patients successfully converted to a resectable state, allowing for surgical intervention.
• Nearly 39% of those who underwent surgery achieved a pathological complete response.
• Half of the surgical group experienced major pathological responses.
The subgroup undergoing surgery demonstrated a median overall survival that was not reached, compared to 14.3 months in those who did not have surgery, highlighting the potential long-term benefits of the therapy. Additionally, adverse reactions were found to be manageable, underscoring the treatment’s safety profile.
Integrating HAIC with donafenib and sintilimab presents a promising strategy for managing uHCC, potentially enabling more patients to undergo curative surgery and improving overall survival rates. These findings could influence future treatment protocols, offering a balanced approach that maximizes efficacy while maintaining patient safety.
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