Neoadjuvant transarterial chemoembolization, camrelizumab, and apatinib for centrally located hepatocellular carcinoma (NEO-CENTACT): study protocol for a phase II trial
Year: 2026
Type: article
Abstract: Background: Centrally located hepatocellular carcinoma (HCC) presents unique challenges due to its close proximity to major vascular structures, which leads to high rates of margin positivity and postoperative recurrence. These challenges underscore the urgent need for effective neoadjuvant strategies. This trial therefore aims to investigate the efficacy and safety of sequential transarterial chemoembolization (TACE) followed by camrelizumab and apatinib as neoadjuvant therapy for patients with centrally located HCC. Methods: This prospective, multicenter, single-arm phase II trial will enroll 52 patients with centrally located HCC. Eligible participants will receive one cycle of TACE followed by camrelizumab [200 mg every 2 weeks (q2w), 4 cycles] and oral apatinib [250 mg once daily (qd), 2 months] prior to surgery. Patients without evidence of disease progression after neoadjuvant therapy will undergo liver resection. The primary endpoint is major pathological response (MPR) (>70% necrosis) rate. Secondary endpoints include objective response rate (ORR), R0 resection rate, pathological complete response (pCR), event-free survival (EFS), overall survival (OS), and safety. Discussion: The triple combination comprising TACE, a tyrosine kinase inhibitor (TKI), and a programmed cell death protein 1 (PD-1) inhibitor represents a rational and promising approach for unresectable HCC. This study aims to evaluate the efficacy and safety of neoadjuvant TACE combined with camrelizumab and apatinib in patients with centrally located, resectable HCC. Trial Registration: ChiCTR2500112222. Date of registration is November 11, 2025. Available at https://www.chictr.org.cn/showproj.html?proj=293381.
Institutions: Sichuan University, West China Hospital of Sichuan University
Language: English
Subfield: Hepatology
Field: Medicine
Domain: Health Sciences
Open Access status: diamond
OpenAlex ID: W7223289848