Department of Hepatobiliary and Pancreatic Surgery, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China.
Zhejiang Provincial Key Laboratory of Pancreatic Disease, Hangzhou, China.
Hepatol Commun. 2023 Feb 9;7(3):e0054. doi: 10.1097/HC9.0000000000000054. eCollection 2023 Mar 1.
Many patients with HCC of Barcelona Clinic Liver Cancer (BCLC) stage A exceeding the Milan criteria, or of BCLC stage B, can undergo resection after successful preoperative therapy, but an optimal approach has not been identified. We investigated preoperative drug-eluting bead transarterial chemoembolization (DEB-TACE) plus sintilimab, in this setting.
In this prospective, phase II study (NCT04174781), adults with HCC of BCLC stage A exceeding the Milan criteria, or BCLC stage B, and ineligible for surgical resection, received sintilimab 200 mg and DEB-TACE. The primary endpoint was progression-free survival by modified RECIST. Secondary endpoints included objective response rate, pathologic response rate, and safety. At the data cutoff (July 2022), among 60 patients, the objective response rate was 62% (37/60) and 51 patients had undergone surgery. After a median follow-up of 26.0 months (range, 3.4-31.8), the median progression-free survival was 30.5 months (95% CI: 16.1-not reached). Among patients undergoing surgery, median progression-free survival was not reached and the 12-month progression-free survival rate was 76% (95% CI: 67-91). A pathologic complete response was achieved in 14% (7/51) of these patients. All patients experienced at least one adverse event, but these were generally manageable. Exploratory analyses showed an association between cytokeratin, V-domain Ig-containing Suppressor of T-cell Activation, CD68, CD169, and cluster 13 fibroblasts and recurrence after surgery.
Sintilimab plus DEB-TACE before surgery showed good efficacy and safety in patients with HCC of BCLC stage A exceeding the Milan criteria or BCLC stage B.
许多巴塞罗那临床肝癌（BCLC）分期 A 超过米兰标准的 HCC 患者，或 BCLC 分期 B 的患者，在术前成功治疗后可以进行切除，但尚未确定最佳方法。我们在此背景下研究了术前载药微球动脉化疗栓塞（DEB-TACE）联合替雷利珠单抗。
在这项前瞻性、二期研究（NCT04174781）中，BCLC 分期 A 超过米兰标准、或 BCLC 分期 B、且不符合手术切除条件的 HCC 成年患者接受替雷利珠单抗 200mg 和 DEB-TACE。主要终点为改良 RECIST 的无进展生存期。次要终点包括客观缓解率、病理缓解率和安全性。在数据截止（2022 年 7 月）时，在 60 例患者中，客观缓解率为 62%（37/60），51 例患者接受了手术。中位随访 26.0 个月（范围，3.4-31.8）后，中位无进展生存期为 30.5 个月（95%CI：16.1-未达到）。在接受手术的患者中，中位无进展生存期未达到，12 个月无进展生存率为 76%（95%CI：67-91）。这些患者中有 14%（7/51）达到病理完全缓解。所有患者均至少发生一次不良事件，但通常可管理。探索性分析显示，手术后复发与角蛋白、V 结构域免疫球蛋白含 T 细胞激活抑制因子、CD68、CD169 和簇 13 成纤维细胞之间存在关联。
替雷利珠单抗联合 DEB-TACE 术前治疗 BCLC 分期 A 超过米兰标准或 BCLC 分期 B 的 HCC 患者具有良好的疗效和安全性。
