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Neoadjuvant therapy of sequential TACE, camrelizumab, and apatinib for single huge hepatocellular carcinoma (NEO-START): study protocol for a randomized controlled trial.
- Source :
-
Trials [Trials] 2024 Jul 19; Vol. 25 (1), pp. 490. Date of Electronic Publication: 2024 Jul 19. - Publication Year :
- 2024
-
Abstract
- Background: The high recurrence rate after liver resection emphasizes the urgent need for neoadjuvant therapy in hepatocellular carcinoma (HCC) to enhance the overall prognosis for patients. Immune checkpoint inhibitors, camrelizumab combined with an anti-angiogenic tyrosine kinase inhibitor (TKI) apatinib, have emerged as a first-line treatment option for patients with unresectable HCC, yet its neoadjuvant application in combination with transarterial chemoembolization (TACE) in HCC remains unexplored. Therefore, this study aims to investigate the efficacy and safety of sequential TACE, camrelizumab, and apatinib as a neoadjuvant therapy for single, huge HCC.<br />Methods: This multi-center, open-label randomized phase 3 trial will be conducted at 7 tertiary hospitals. Patients with single huge (≥ 10 cm in diameter), resectable HCC will be randomly assigned in a 1:1 ratio to arm of surgery alone or arm of neoadjuvant therapy followed by surgery. In the neoadjuvant therapy group, patients will receive TACE within 1 week after randomization, followed by camrelizumab (200 mg q2w, 4 cycles), along with apatinib (250 mg qd, 2 months). Patients will receive liver resection after neoadjuvant therapy unless the disease is assessed as progressive. The primary outcome is recurrence-free survival (RFS) at 1 year. The planned sample size of 60 patients will be calculated to permit the accumulation of sufficient RFS events in 1 year to achieve 80% power for the RFS primary endpoint.<br />Discussion: Synergistic effects provided by multimodality therapy of locoregional treatment, TKI, and anti-programmed cell death 1 inhibitor significantly improved overall survival for patients with unresectable HCC. Our trial will investigate the efficacy and safety of the triple combination of TACE, camrelizumab, and apatinib as a neoadjuvant strategy for huge, resectable HCC.<br />Trial Registration: www.chitr.org.cn ChiCTR2300078086. Registered on November 28, 2023. Start recruitment: 1st January 2024. Expected completion of recruitment: 15th June 2025.<br /> (© 2024. The Author(s).)
- Subjects :
- Humans
Randomized Controlled Trials as Topic
Antineoplastic Combined Chemotherapy Protocols therapeutic use
Antineoplastic Combined Chemotherapy Protocols adverse effects
Male
Hepatectomy
Adult
Middle Aged
Multicenter Studies as Topic
Clinical Trials, Phase III as Topic
Female
Treatment Outcome
China
Aged
Carcinoma, Hepatocellular therapy
Carcinoma, Hepatocellular pathology
Carcinoma, Hepatocellular mortality
Carcinoma, Hepatocellular drug therapy
Liver Neoplasms therapy
Liver Neoplasms pathology
Liver Neoplasms mortality
Liver Neoplasms drug therapy
Chemoembolization, Therapeutic adverse effects
Chemoembolization, Therapeutic methods
Pyridines therapeutic use
Pyridines administration & dosage
Pyridines adverse effects
Antibodies, Monoclonal, Humanized therapeutic use
Antibodies, Monoclonal, Humanized administration & dosage
Antibodies, Monoclonal, Humanized adverse effects
Neoadjuvant Therapy adverse effects
Subjects
Details
- Language :
- English
- ISSN :
- 1745-6215
- Volume :
- 25
- Issue :
- 1
- Database :
- MEDLINE
- Journal :
- Trials
- Publication Type :
- Academic Journal
- Accession number :
- 39030637
- Full Text :
- https://doi.org/10.1186/s13063-024-08340-1