Postoperative adjuvant therapy with donafenib in hepatocellular carcinoma with high-risk recurrence factors: A real-world, prospective, observational study.

e16316 Background: The five-year recurrence rate of hepatocellular carcinoma (HCC) after hepatic resection is as high as 70% and remains a major clinical challenge. Although some reports have suggested adjuvant therapy to prevent HCC recurrence, more studies should be further carried out to confirm its effectiveness . Donafenib has been approved as a standard treatment for patients with unresectable HCC in China. Here, we describe our preliminary results regarding the efficacy and safety of donafenib as an adjuvant therapy for patients with HCC after hepatectomy. Methods: This was an observational study of patients with HCC following hepatectomy treated with donafenib in routine practice at Sun Yat-sen Memorial Hospital, Sun Yat-sen University. The enrolled patients were 75 years or younger, had been diagnosed with HCC, showed no evidence of recurrence at radiological follow-up within one month after hepatectomy, and had at least one high recurrence risk factor, such as tumor diameter ≥5 cm, tumor number ≥2, microvascular invasion, or serum a-fetoprotein level before surgery ≥400 ng/mL. All of the patients had adequate hematologic, hepatic, and renal functions. The primary endpoint was recurrence-free survival (RFS), and the secondary endpoints included 6- and 12-month RFS rates, overall survival, and adverse events. Results: 47 patients were enrolled in this study. The median age was 58 years (range, 30–72), 91.5% were males, 80.9% with HBV, 23.4% had preoperative serum a-fetoprotein levels ≥400 ng/mL, 31.9% had tumor diameters ≥5 cm, 40.4% had tumor numbers ≥2, and 36.2% had microvascular invasion. The median follow-up time for the entire patient cohort was 28.8 months (95% confidence interval [CI], 24.6–35.2), and 17 of 47 patients relapsed, with a recurrence rate of 36.2%. The median RFS was not reached; the 6-, 12- and 24-month RFS rates were 85.1%, 73.7% and 63.6%, respectively. And the median OS was not reached; the 6-, 12- and 24-month OS rates were 100%, 97.7% and 91.8%, respectively. Treatment-related adverse events (TRAEs) occurred in 87.2% of the patients, most of which were grades 1–2. Grade 3/4 TRAEs, including hand-foot skin reaction, severe rash and GI bleeding, were observed in 12 (25.5%) patients. No grade 5 TRAEs occurred. Conclusions: The current study suggests that donafenib as adjuvant therapy may be a potentially effective way to prevent HCC recurrence after curative surgery. This findings are being validated by a multi-center, prospective, random control trial (NCT06581315). Clinical trial information: ChiCTR2200064030 .