Given the promising outcomes of stereotactic body radiation therapy (SBRT) in treating colorectal cancer liver metastases (CRLMs), we proposed an innovative strategy combining surgery with planned liver SBRT for CRLMs. This retrospective study included patients who underwent curative-intent surgery combined with planned liver SBRT from July 2019 to October 2023. Planned liver SBRT was delivered to residual unresectable and unablatable lesions with maximum diameters of ≤5 cm. Outcomes included local failure (LF), intrahepatic recurrence-free survival (IHRFS), extrahepatic recurrence-free survival (EHRFS), progression-free survival (PFS), overall survival (OS), and radiation-related adverse events. A total of 69 patients were included. The 1-, and 2-year cumulative incidence rates of LF after SBRT were 7.7%, and 9.6%, respectively. The median PFS was 6.2 months, and the median OS was 45.8 months. Multivariate analysis identified RAS/BRAF mutations, extrahepatic metastases excluding lung involvement, and higher CEA as independent predictors of poorer OS. Intrahepatic recurrence was the predominant pattern of first disease progression after combination treatment. Acute grade 1–2 radiation-related adverse events occurred in 56.5% of patients, while grade 3 toxicities were reported in 4.3%. This approach offers favorable long-term outcomes, suggesting its potential to broaden the indications for curative-intent local treatments in CRLMs.
PURPOSE: Given the underexplored combination of immune checkpoint inhibitors, tyrosine kinase inhibitors (TKIs), and radiotherapy in locally advanced, unresectable hepatocellular carcinoma (HCC), this study aimed to evaluate camrelizumab (a PD-1 inhibitor), apatinib (a TKI), and intensity-modulated radiotherapy (IMRT) for this setting and identify potential biomarkers. PARTICIPANTS AND METHODS: This single-arm phase 2 trial enrolled locally advanced, unresectable HCC patients who were systemic treatment-naïve or refractory/intolerant to first-line targeted therapy. Patients received IMRT (50-60 Gy) to all lesions plus camrelizumab (200 mg intravenously every 3 weeks) and apatinib (250 mg orally once daily) for up to 2 years. Primary endpoint was progression-free survival (PFS); secondary endpoints included response, overall survival (OS), and safety. RESULTS: Between October, 2020, and November, 2024, 44 patients were enrolled. 40 patients (90.9%) had BCLC stage C disease, including macrovascular invasion in 36 (81.8%) and lymph node spread in 11 (25.0%) cases. Objective response rate was 84.1%. The median PFS was 13.8 months and median OS was not reached. The 24-month PFS rate was 38.1% and OS rate was 70.2%, respectively. Grade 3-4 treatment-related adverse events occurred in 36 patients (81.8%), the most common being thrombocytopenia (36.4%) and hypertension (29.5%). No treatment-related deaths were observed. TP53 mutation in circulating tumor DNA was associated with worse clinical outcomes. CONCLUSION: Camrelizumab and apatinib with radiotherapy demonstrated encouraging efficacy with manageable toxicity in locally advanced, unresectable HCC, warranting randomized trials validation.
Purpose:Given the underexplored combination of immune checkpoint inhibitors, tyrosine kinase inhibitors (TKI), and radiotherapy in locally advanced, unresectable hepatocellular carcinoma (HCC), this study aimed to evaluate camrelizumab (a programmed cell death protein 1 inhibitor), apatinib (a TKI), and intensity-modulated radiotherapy (IMRT) for this setting and identify potential biomarkers. Patients and Methods:This single-arm phase II trial enrolled patients with locally advanced, unresectable HCC who were systemic treatment-naïve or refractory/intolerant to first-line targeted therapy. Patients received IMRT (50–60 Gy) to all lesions plus camrelizumab (200 mg intravenously every 3 weeks) and apatinib (250 mg orally once daily) for up to 2 years. The primary endpoint was progression-free survival (PFS); secondary endpoints included response, overall survival (OS), and safety. Results:Between October 2020 and November 2024, 44 patients were enrolled. Forty patients (90.9%) had Barcelona Clinic Liver Cancer stage C disease, including macrovascular invasion in 36 (81.8%) and lymph node spread in 11 (25%) cases. The objective response rate was 84.1%. The median PFS was 13.8 months, and the median OS was not reached. The 24-month PFS rate was 38.1%, and the OS rate was 70.2%. Grade 3 to 4 treatment-related adverse events occurred in 36 patients (81.8%), the most common being thrombocytopenia (36.4%) and hypertension (29.5%). No treatment-related deaths were observed. TP53 mutation in circulating tumor DNA was associated with worse clinical outcomes. Conclusions:Camrelizumab and apatinib with radiotherapy demonstrated encouraging efficacy with manageable toxicity in locally advanced, unresectable HCC, warranting randomized trials for validation.