Transarterial Chemoembolization Combined With Camrelizumab and Rivoceranib for Unresectable Hepatocellular Carcinoma (CHANCE2005/CARES-005): A Randomized Phase II Trial.

This phase II trial compared TACE combined with camrelizumab (anti-PD-1 antibody) and rivoceranib (vascular endothelial growth factor receptor 2 inhibitor) versus TACE in unresectable HCC.

这项II期临床试验比较了TACE联合卡瑞利珠单抗（抗PD-1抗体）和阿瓦斯汀（血管内皮生长因子受体2抑制剂）与单纯TACE在不可切除性HCC中的疗效。

Methods

Patients with unresectable HCC (Barcelona Clinic Liver Cancer stage A to C without extrahepatic metastases) and Child-Pugh class A liver function were randomly assigned (1:1), stratified by macrovascular invasion, previous tyrosine kinase inhibitor treatment, and number of previous TACE procedures, to receive TACE combined with camrelizumab (200 mg once every 3 weeks) and rivoceranib (250 mg once daily; TACE-C-R) or TACE alone.

无法切除的肝细胞癌（HCC）患者（巴塞罗那临床肝癌分期A至C，无肝外转移）和Child-Pugh A级肝功能的患者被随机分配（1:1），按大血管侵犯、先前的酪氨酸激酶抑制剂治疗和既往TACE程序次数进行分层，接受TACE联合卡瑞利珠单抗（每3周200毫克）和瑞沃替尼（每天250毫克；TACE-C-R）或单独TACE治疗。

The primary end point was progression-free survival(PFS) per composite criteria (progression per Response Evaluation Criteria in Cancer of the Liver version 5, transient deterioration to Child-Pugh class C, or TACE failure or refractoriness) in the intention-to-treatpopulation.

主要终点是意向治疗人群中无进展生存期（PFS），根据综合标准（根据癌症肝脏版本5的反应评估标准进展、暂时恶化至Child-Pugh C级，或TACE失败或耐药）进行评估。

Results

Between December 28, 2020, and October 29, 2023, 200 patients were randomly assigned (100 in each group).

在2020年12月28日至2023年10月29日期间，200名患者被随机分配（每组各100名）。

Median PFS per composite criteria was significantly longer with TACE-C-R than with TACE (10.8 months [95% CI, 8.8 to 13.7] v 3.2 months [95% CI, 2.4 to 4.2]; hazard ratio, 0.34 [95% CI, 0.24 to 0.50], P < .001).

根据综合标准，TACE-C-R组的中位无进展生存期显著长于TACE组（10.8个月 [95% 置信区间, 8.8至13.7] 对比 3.2个月 [95% 置信区间, 2.4至4.2]；风险比为0.34 [95% 置信区间, 0.24至0.50]，P < .001）。

Grade ≥3 treatment-related adverse events occurred in 74.5% (70 of 94) of patients with TACE-C-R and 22.3% (23 of 103) of patients with TACE, with the most common being increased AST (29 [30.9%] and 13 [12.6%]) and increased ALT (23 [24.5%] and 14 [13.6%]).

在接受TACE-C-R治疗的94名患者中，74.5%（70/94）出现了3级或更高级别的治疗相关不良事件，而在接受TACE治疗的103名患者中，这一比例为22.3%（23/103）。最常见的不良事件是AST升高（分别为29例[30.9%]和13例[12.6%]）和ALT升高（分别为23例[24.5%]和14例[13.6%]）。

Conclusions

The addition of camrelizumab and rivoceranib to TACE showed statistically significant improvement in PFS for patients with unresectable HCC, with a manageable safety profile.

将卡瑞利珠单抗和瑞沃替尼添加到TACE中，对于不可切除的HCC患者，显示出在无进展生存期（PFS）方面的统计学显著改善，并具有可管理的安全性特征。

Follow-up for further overall survivalanalysis is ongoing.

进一步总生存分析的随访正在进行中。