drugset / Trial / NCT03510871
Nivolumab Plus Ipilimumab as Neoadjuvant Therapy for Hepatocellular Carcinoma (HCC)
Phase 2
Completed
43 enrolled
National Health Research Institutes, Taiwan
Chang Gung Memorial Hospital · collabChina Medical University Hospital · collabMackay Memorial Hospital · collabNational Cheng-Kung University Hospital · collabNational Taiwan University Hospital · collabTaipei Veterans General Hospital, Taiwan · collabTri-Service General Hospital (TSGH) · collab
NaSingle-groupOpen-labelTreatment
Summary
Objectives: 1. To evaluate the efficacy, in terms of tumor shrinkage, objective response rate, and down-stage rate, of nivolumab + ipilimumab as neoadjuvant therapy for patients with HCC; 2. To evaluate the safety profile in patients with HCC who receive neoadjuvant nivolumab + ipilimumab treatment; 3. To collect HCC tumor tissue and peripheral blood samples from the patients for a comprehensive biomarker evaluation for nivolumab + ipilimumab immunotherapy.
Timeline
- Start
- 2019-02-12
- Primary completion
- 2024-05-31
- Completion
- 2024-05-31
Publications
- Lin YJ, Ou DL, Su YY, Hsu CL, Hsiao CF, Ko BS, Chen SC, Wang HW, Wang JH, Wu YM, Jeng YM, Lee WC, Chou SC, Chen TW, Chiu CF, Lin JS, Hsieh CH, Lee CC, Shan YS, Cheng AL, Chen LT, Hsu C. Nivolumab plus ipilimumab for potentially resectable hepatocellular carcinoma: Long-term efficacy and biomarker exploration. J Hepatol. 2026 Feb;84(2):316-328. doi: 10.1016/j.jhep.2025.08.035. Epub 2025 Sep 17.
- D'Alessio A, Stefanini B, Blanter J, Adegbite B, Crowley F, Yip V, Slater S, Fulgenzi CAM, Celsa C, Manfredi GF, Pai M, Goldin RD, Ward SC, Fiel MI, Shu DH, Su YY, Cortellini A, Baretti M, Anders R, Yarchoan M, Hsu C, Marron TU, Pinato DJ. Pathological response following neoadjuvant immune checkpoint inhibitors in patients with hepatocellular carcinoma: a cross-trial, patient-level analysis. Lancet Oncol. 2024 Nov;25(11):1465-1475. doi: 10.1016/S1470-2045(24)00457-1. Epub 2024 Oct 19.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ipilimumab | Monoclonal antibody | 1 mg/kg | Intravenous |
| Subject | Nivolumab | Monoclonal antibody | 3 mg/kg | Intravenous |