drugset / Trial / NCT05062837
Hepatectomy Combined With Camrelizumab and Apatinib in CNLC Stage IIIb HCC
Phase 2/3
Unknown
62 enrolled
Guangxi Medical University
Jiangsu HengRui Medicine Co., Ltd. · collab
NaSingle-groupOpen-labelTreatment
Summary
This study intends to prospectively enroll CNLC stage IIIb HCC cases with extrahepatic metastasis and intrahepatic lesions that are expected to be radical resected in several domestic clinical centers, and observe the OS and ORR, DCR, DOR, TTP and PFS of patients receiving hepatectomy combined with apatinib + carrelli pearl treatment.
Timeline
- Start
- 2021-06-01
- Primary completion
- 2024-09-30
- Completion
- 2024-12-31
Publications
- Background Xu J, Shen J, Gu S, Zhang Y, Wu L, Wu J, Shao G, Zhang Y, Xu L, Yin T, Liu J, Ren Z, Xiong J, Mao X, Zhang L, Yang J, Li L, Chen X, Wang Z, Gu K, Chen X, Pan Z, Ma K, Zhou X, Yu Z, Li E, Yin G, Zhang X, Wang S, Wang Q. Camrelizumab in Combination with Apatinib in Patients with Advanced Hepatocellular Carcinoma (RESCUE): A Nonrandomized, Open-label, Phase II Trial. Clin Cancer Res. 2021 Feb 15;27(4):1003-1011. doi: 10.1158/1078-0432.CCR-20-2571. Epub 2020 Oct 21.
- Background Finn RS, Ikeda M, Zhu AX, Sung MW, Baron AD, Kudo M, Okusaka T, Kobayashi M, Kumada H, Kaneko S, Pracht M, Mamontov K, Meyer T, Kubota T, Dutcus CE, Saito K, Siegel AB, Dubrovsky L, Mody K, Llovet JM. Phase Ib Study of Lenvatinib Plus Pembrolizumab in Patients With Unresectable Hepatocellular Carcinoma. J Clin Oncol. 2020 Sep 10;38(26):2960-2970. doi: 10.1200/JCO.20.00808. Epub 2020 Jul 27.
- Background Finn RS, Qin S, Ikeda M, Galle PR, Ducreux M, Kim TY, Kudo M, Breder V, Merle P, Kaseb AO, Li D, Verret W, Xu DZ, Hernandez S, Liu J, Huang C, Mulla S, Wang Y, Lim HY, Zhu AX, Cheng AL; IMbrave150 Investigators. Atezolizumab plus Bevacizumab in Unresectable Hepatocellular Carcinoma. N Engl J Med. 2020 May 14;382(20):1894-1905. doi: 10.1056/NEJMoa1915745.
- Background Huang JT, Zhong JH, Zhang J, Gong WF, Ma L, Li LQ, Xiang BD. Hepatectomy combined with apatinib and camrelizumab for CNLC stage IIIb hepatocellular carcinoma: a phase II trial protocol. BMJ Open. 2023 Sep 28;13(9):e067730. doi: 10.1136/bmjopen-2022-067730.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Camrelizumab | Monoclonal antibody | — | — |
| Subject | Rivoceranib | Small molecule | — | — |