Department of Geriatric Medicine & National Clinical Research Centre of Geriatric Disease, The Second Medical Center, Chinese PLA General Hospital, No. 28 Fuxing Road, Haidian District, Beijing, 100853, China.
Department of Interventional Radiology, Chinese PLA General Hospital, Beijing, 100853, China.
J Cancer Res Clin Oncol. 2024 Sep 20;150(9):427. doi: 10.1007/s00432-024-05949-2.
The treatment of unresectable hepatocellular carcinoma (uHCC) challenging due to unfulfilled clinical requirements.
To evaluate the safety and efficacy of combining transarterial chemoembolization (TACE) with sintilimab and lenvatinib in the treatment of uHCC.
We retrospectively analyzed the data of patients with uHCC who were treated with a combination of TACE, sintilimab, and lenvatinib between May 2019 and December 2021 at the Chinese PLA General Hospital. Systemic treatment was started 1 week after TACE was performed. Sintilimab was administered intravenously at a dosage of 200 mg every three weeks, and lenvatinib was given orally at dosages of 8 mg or 12 mg daily, contingent upon the weight of the patients. The primary endpoint was the objective response rate (ORR) as per the mRECIST. Secondary endpoints were disease control rate (DCR), progression-free survival (PFS), overall survival (OS) and treatment-related adverse events (tr-AEs).
A total of 32 patients were enrolled in the study. Among them, 9 patients were classified as Barcelona Clinic Liver Cancer-B (BCLC-B), 23 patients were classified as BCLC-C, 14 patients diagnosed with portal vein tumors, and 12 patients were diagnosed with extra hepatic metastases. The ORR and DCR were 75% and 90.6% respectively, with 4 patients exhibiting (12.5%) complete response, 20 patients exhibiting (62.5%) partial response, 5 patients exhibiting (15.6%) stable disease, and 3 patients exhibiting (9.4%) progressive disease. With a median follow-up time of 19.6 months, the median PFS was 9.9 months, and the median OS was 33.3 months. A total of 31 patients experienced different degrees of tr-AEs, of which 2 were grade 3 tr-AEs.
The combination therapy of TACE, sintilimab, and lenvatinib demonstrates satisfactory efficacy in the treatment of uHCC with manageable tr-AEs.
由于未满足的临床需求，不可切除肝细胞癌（uHCC）的治疗具有挑战性。
评估经动脉化疗栓塞（TACE）联合信迪利单抗和仑伐替尼治疗 uHCC 的安全性和有效性。
我们回顾性分析了 2019 年 5 月至 2021 年 12 月在中国人民解放军总医院接受 TACE、信迪利单抗和仑伐替尼联合治疗的 uHCC 患者的数据。全身治疗在 TACE 后 1 周开始。信迪利单抗静脉输注，每 3 周 200mg；仑伐替尼口服，根据患者体重，每日剂量为 8mg 或 12mg。主要终点为根据 mRECIST 评估的客观缓解率（ORR）。次要终点为疾病控制率（DCR）、无进展生存期（PFS）、总生存期（OS）和治疗相关不良事件（tr-AEs）。
共有 32 名患者入组研究。其中，9 名患者为巴塞罗那临床肝癌-B（BCLC-B）期，23 名患者为 BCLC-C 期，14 名患者有门静脉肿瘤，12 名患者有肝外转移。ORR 和 DCR 分别为 75%和 90.6%，4 例（12.5%）完全缓解，20 例（62.5%）部分缓解，5 例（15.6%）稳定，3 例（9.4%）进展。中位随访时间为 19.6 个月，中位 PFS 为 9.9 个月，中位 OS 为 33.3 个月。31 例患者发生不同程度的 tr-AEs，其中 2 例为 3 级 tr-AEs。
TACE、信迪利单抗和仑伐替尼联合治疗方案治疗 uHCC 具有良好的疗效，且 tr-AEs 可管理。
