卡瑞利珠单抗联合阿帕替尼治疗肝细胞癌临床应用专家共识

中国临床肿瘤学会肝癌专家委员会; 中国临床肿瘤学会抗肿瘤药物安全管理专家委员会

doi:10.12449/JCH260710

卡瑞利珠单抗联合阿帕替尼治疗肝细胞癌临床应用专家共识

DOI: 10.12449/JCH260710

脚注:

利益冲突声明：所有专家均声明不存在利益冲突。

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出版历程
- 收稿日期: 2026-06-17
- 录用日期: 2026-06-27
- 出版日期: 2026-07-25

Expert consensus on clinical application of camrelizumab combined with apatinib in the treatment of hepatocellular carcinoma

摘要

摘要: 卡瑞利珠单抗联合阿帕替尼已经获得国家药品监督管理局批准一线治疗肝细胞癌的适应证，迄今已经积累了一系列肝癌相关的临床研究证据和实践经验。为了指导临床上更加合理、有效地使用卡瑞利珠单抗联合阿帕替尼治疗肝细胞癌，中国临床肿瘤学会肝癌专家委员会与抗肿瘤药物安全管理专家委员会，共同组织了全国肝癌以及有关领域的多学科专家学者，经过认真讨论和反复修改，最终形成本专家共识，旨在为临床医师提供科学、规范的实践指导。
- 卡瑞利珠单抗 /
- 阿帕替尼 /
- 癌，肝细胞 /
- 专家共识
Abstract: Camrelizumab combined with apatinib has been approved by the National Medical Products Administration （NMPA） as a first-line therapeutic regimen for hepatocellular carcinoma （HCC）， and a wealth of clinical research evidence and practical experience associated with liver cancer has been accumulated to date. To guide the rational and effective clinical administration of camrelizumab combined with apatinib for HCC treatment， Expert Committee for Liver Cancer and Expert Committee on Safety Management of Anti-Tumor Drugs， Chinese Society of Clinical Oncology， jointly organized multidisciplinary experts and scholars specializing in liver cancer and related disciplines nationwide. This expert consensus has been formulated after thorough discussions and repeated revisions， in order to provide standardized and evidence-based clinical guidance for clinicians.
- Camrelizumab for Injection /
- Apatinib /
- Carcinoma， Hepatocellular /
- Expert Consensus

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表 1 CSCO专家共识的证据类别

Table 1. CSCO expert consensus evidence categories

证据类别	水平	来源	专家共识度
1A	高	严谨的Meta分析、大型随机对照临床研究	一致共识（支持意见≥80%）
1B	高	严谨的Meta分析、大型随机对照临床研究	基本一致共识，但争议小（支持意见 60%～80%）
2A	稍低	一般质量的Meta分析、小型随机对照研究、设计良好的大型回顾性研究、病例-对照研究	一致共识（支持意见≥80%）
2B	稍低	一般质量的Meta分析、小型随机对照研究、设计良好的大型回顾性研究、病例-对照研究	基本一致共识，但争议小（支持意见 60%～80%）
3	低	非对照的单臂临床研究、病例报告、专家观点	无共识，且争议大（支持意见<60%）
注：CSCO，中国临床肿瘤学会。

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表 2 CSCO专家共识的推荐等级

Table 2. CSCO expert consensus recommendation grades

推荐等级	标准
Ⅰ级推荐	1A类证据和部分2A类证据一般情况下，将1A类证据和部分专家共识度高且在中国可及性好的2A类证据作为Ⅰ级推荐。具体来说，Ⅰ级推荐具有如下特征：可及性好的普适性诊治措施（包括适应证明确），肿瘤治疗价值相对稳定，基本为国家医保所收录；Ⅰ 级推荐的确定，不因商业医疗保险而改变，主要考虑的因素是患者的明确获益性
Ⅱ级推荐	1B类证据和部分2A类证据一般情况下，将1B类证据和部分专家共识度稍低或在中国可及性不太好的2A类证据作为Ⅱ级推荐。具体来说，Ⅱ 级推荐具有如下特征：在国际或国内已有随机对照的多中心研究提供的高级别证据，但是可及性差或者效价比低，已超出平民经济承受能力的药物或治疗措施；对于获益明显但价格昂贵的措施，以肿瘤治疗价值为主要考虑因素，也可以作为Ⅱ级推荐
Ⅲ级推荐	2B类证据和部分3类证据对于正在探索的诊治手段，虽然缺乏强有力的循证医学证据，但是专家组具有一致共识的，可以作为Ⅲ级推荐供医疗人员参考
注：CSCO，中国临床肿瘤学会。

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表 3 阿帕替尼的剂量调整

Table 3. Dose adjustment of Apatinib

项目	剂量水平	CTAE不良事件分级≥2级
初始剂量	250 mg，每日1次	可酌情考虑患者具体情况依序进行阿帕替尼剂量调整，或直接调整到250 mg，隔天用药
第1次调整	250 mg，用药5天停药2天
第2次调整	250 mg，隔1天1次
第3次及以上调整	个体化剂量调整	根据患者的综合情况进行个体化剂量调整
注：CTAE，美国国家癌症研究所《常见不良事件评价标准》。

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表 4 阿帕替尼常见不良反应分级和防治建议

Table 4. Grading and recommended management of common adverse events associated with Apatinib

不良反应	分级	描述	防治建议
高血压	1级	收缩压120～139 mmHg，舒张压80～89 mmHg	•血压水平130～139/85～89 mmHg、心血管风险为高危和很高危者应立即启动降压药物治疗 •严密监测血压，限盐，戒烟酒 •继续服用阿帕替尼，无需剂量调整
	2级	收缩压140～159 mmHg，舒张压90～99 mmHg，如果既往在正常值范围内；相比基线血压水平发现变化需要医学干预；反复或持续（≥24 h）症状性收缩期血压升高>20 mmHg或>140/90 mmHg；需要给予单药治疗	•严密监测血压 •继续服用阿帕替尼，一般无需剂量调整 •应采用降压药治疗，且不得随意停药
	3级	收缩压≥160 mmHg，舒张压≥100 mmHg；需要医学干预；需要多种药物治疗或更强化的治疗	•严密监测血压 •暂停服用阿帕替尼 •请心血管专科医师会诊和治疗 •若单药控制不良的高血压，应考虑联合用药 •如血压控制良好，可降低剂量后继续服用阿帕替尼
	4级	危及生命（如恶性高血压，一过性或持久性神经功能缺损，高血压危象）；需要紧急治疗	•严密监测血压和其他生命体征 •请心血管专科医师会诊，积极处理高血压 •立即和永久停服阿帕替尼
蛋白尿	1级	蛋白尿1+，24 h尿蛋白定量≥ULN～<1.0 g	• 继续服用阿帕替尼，一般无需剂量调整
	2级	尿蛋白2+/3+；24 h尿蛋白定量1.0～3.5 g	•暂停用药，待不良反应恢复到≤1级，以原剂量继续用药
	3级	24 h尿蛋白定量≥3.5 g；尿蛋白4+	•暂停用药，待不良反应恢复到≤1级，下调一个剂量后继续用药 •如出现肾病综合征，则永久停药
掌跖红肿综合征	1级	无痛性轻微皮肤改变或皮炎（如红斑，水肿或过度角化）	•继续服用阿帕替尼，一般无需剂量调整 •症状初现时局部用药治疗
	2级	痛性皮肤改变（如剥落、水泡、出血、皲裂、水肿、过度角化）；影响工具性日常生活活动	•继续服用阿帕替尼，可适当调整剂量 •局部治疗 •口服B族维生素和塞来昔布，可联合抗炎症或抗感染药物
	3级	重度皮肤改变（剥落、水泡、出血、皲裂、水肿、角化过度），伴疼痛；影响自理性日常生活活动	•暂停用药 •镇痛处理和局部用药治疗 •可联合抗炎症或抗感染用药 •如果症状缓解，可降低剂量服用阿帕替尼；如持续存在和加重，应终止服用阿帕替尼
肝功能异常		•AST或ALT>3倍ULN（或基线值^*）且≤10倍ULN，同时TBil≤2倍ULN •血胆红素>1.5～3倍ULN（基线值正常）或1.5～ 3倍基线值（基线值异常）	•暂停用药，直至不良反应恢复到≤1级或基线，下调一个剂量后继续用药
肝功能异常		•AST或ALT>10倍ULN •AST或ALT>3倍ULN（或基线值^*），同时TBil>2 倍ULN •血胆红素>3～10倍ULN（基线值正常）或3～10 倍基线值（基线值异常）	•永久停药
血液学毒性	3级	白细胞<1.5～1.0×10⁹/L；中性粒细胞<1.0～ 0.5×10⁹/L；血小板<50～25×10⁹/L	•暂停用药，待不良反应恢复到≤2级，以原剂量继续用药 •如再次出现3级或以上不良反应，则下调一个剂量后继续用药
血液学毒性	4级	白细胞<1.0×10⁹/L；中性粒细胞<0.5×10⁹/L；血小板<25×10⁹/L	•暂停用药，待不良反应恢复到≤2级，下调一个剂量后继续用药
注：*若ALT或AST基线状态异常，则用基线值代替ULN。ALT，丙氨酸氨基转氨酶；AST，天冬氨酸氨基转移酶；ULN，正常值上限；TBil，总胆红素。

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表 5 卡瑞利珠单抗相关不良反应的防治建议

Table 5. Management strategies for camrelizumab-related adverse events

不良反应	分级	分级描述	防治建议
反应性皮肤毛细血管增生症	1级	单个或多个皮肤和/或黏膜结节，最大结节直径≤10 mm，伴或不伴局部破溃出血	•继续ICI治疗 •易摩擦部位可用纱布或创可贴保护，避免出血 •局部破溃出血者可采用局部压迫止血治疗
	2级	单个或多个皮肤和/或黏膜结节，最大结节直径>10 mm，伴或不伴局部破溃出血	•继续ICI治疗 •易摩擦部位可用纱布或创可贴保护，避免出血；局部破溃出血者可采用创可贴、压迫止血，或采取局部治疗措施，如激光或外科切除等；宜加强皮肤消毒，预防破溃处发生感染
	3级	皮肤和/或黏膜结节呈泛发性，可并发感染，严重者可能需要住院治疗	•暂停ICI治疗，待恢复至≤1级后恢复给药 •易摩擦部位可用纱布或创可贴保护，避免出血 •局部破溃出血者可采用创可贴、压迫止血治疗，或采取局部治疗措施，如激光止血或外科切除等 •并发感染者给予抗感染治疗
其他免疫相关不良反应	参照《CSCO免疫检查点抑制剂相关的毒性管理指南》进行防治处理
注：迄今尚未发生反应性皮肤毛细血管增生症相关的4级危及生命和5级死亡不良事件。ICI，免疫检查点抑制剂；CSCO，中国临床肿瘤学会。

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