肝癌 在华治疗
中国于2023年1月批准卡瑞利珠单抗联合rivoceranib(阿帕替尼)作为不可切除肝癌的一线治疗;FDA此前已发出三封完整回复函,理由涉及生产问题,重新提交的申请已于2026年10月递交。武威和上海的碳离子治疗中心提供肝脏肿瘤的碳离子治疗。
已核验最后核验
可用疗法
| 可用疗法 | 在华状态 | 在美状态 | 信息来源 |
|---|---|---|---|
| Camrelizumab plus rivoceranib (apatinib), first-line unresectable HCC | 在中国已获批 | 未获批 | Elevar Therapeutics / GlobeNewswireJiangsu Hengrui Pharmaceuticals |
| Carbon ion radiotherapy | 已开展 | 未知 | Elevar TherapeuticsGansu Wuwei Heavy Ion Center |
| Liver transplant | 已开展 | 在中国已获批 |
有公开项目的医院
以下为有来源的公开信息,不构成推荐。
Shanghai复旦大学附属中山医院Zhongshan Hospital, Fudan UniversityInternational deptVerified
Shanghai复旦大学附属肿瘤医院Fudan University Shanghai Cancer CenterInternational deptReported
Shanghai上海市质子重离子医院Shanghai Proton and Heavy Ion CenterInternational deptJCIVerified
Xiamen厦门大学附属中山医院Zhongshan Hospital, Xiamen UniversityInternational deptVerified
Beijing北京大学肿瘤医院Peking University Cancer Hospital (Beijing Cancer Hospital)No public intl deptVerified
Guangzhou中山大学肿瘤防治中心Sun Yat-sen University Cancer CenterInternational deptVerified
Hainan / Boao Lecheng博鳌超级医院Boao Super HospitalInternational deptVerified
Guangzhou暨南大学附属第一医院(广州华侨医院)The First Affiliated Hospital of Jinan University (Guangzhou Overseas Chinese Hospital)International deptVerified
Tianjin天津医科大学肿瘤医院(天津市肿瘤医院)Tianjin Medical University Cancer Institute and Hospital (Tianjin Cancer Hospital)International deptVerified
Guangzhou中山大学附属第三医院The Third Affiliated Hospital of Sun Yat-sen UniversityInternational deptVerified
Shenzhen中国医学科学院肿瘤医院深圳医院Cancer Hospital, Chinese Academy of Medical Sciences, Shenzhen CenterNo public intl deptVerified
费用
| Entry | Amount | Year | Source | Status |
|---|---|---|---|---|
| Liver transplant · Shanghai | ¥200,000 about $28,169 | 2025 | Sixth Tone | 有报道 |
临床试验
351项研究正在中国招募(ClinicalTrials.gov,截至 2026-10-26). 查看列表
我们只提供试验链接;是否入组由试验团队决定。据 AFP 报道,自 2026 年 5 月起中国禁止向患者收取临床研究费用。
常见问题
卡瑞利珠单抗联合rivoceranib为何未在美国获批?
FDA于2026年7月发出的完整回复函援引了rivoceranib生产工厂的CGMP缺陷;恒瑞方面表示该函不涉及临床数据、安全性或有效性。Elevar已于2026年10月9日重新提交申请。
[1] Jiangsu Hengrui Pharmaceuticals[2] Elevar Therapeutics信息来源
- Elevar Therapeutics Receives FDA Complete Response Letter for rivoceranib plus camrelizumab in HCC
“Camrelizumab is currently approved for eight indications in China, including relapsed/refractory classic Hodgkin's lymphoma (third-line) and esophageal squamous cell carcinoma.”
- Hengrui Pharma Receives Complete Response Letter from FDA for Camrelizumab in Combination with Rivoceranib
“The FDA's decision was related to deficiencies identified during a CGMP surveillance inspection of a manufacturing site associated with rivoceranib.”
- Elevar Therapeutics Resubmits NDA to FDA for camrelizumab plus rivoceranib
“Elevar resubmitted the NDA on October 9, 2026, in response to the CRL.”
- Introduction to the Heavy Ion Centers in Wuwei and Lanzhou
“Patients from across China and countries such as Belgium, South Korea, and Australia routinely seek treatment at these centers.”
- Particle therapy facilities in clinical operation
“Lists SPHIC Shanghai (proton and carbon ion, from 2014/2015), WPTC Wanjie Zibo (proton, 2004) and the Wuwei Heavy Ion Therapy Center (carbon ion).”
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