Neoadjuvant transarterial chemoembolization, camrelizumab, and apatinib for centrally located hepatocellular carcinoma (NEO-CENTACT): study protocol for a phase II trial.
4 affiliations
- 1Division of Liver Surgery, Department of General Surgery, West China Hospital, Sichuan University, Chengdu, China.
- 2Department of Hepatobiliary Surgery, Anyue County People's Hospital, Ziyang, China.
- 3Department of Hepatobiliary Surgery, Pidu District People's Hospital, Chengdu, China.
- 4Chinese Evidence-Based Medicine Center, West China Hospital, Sichuan University, Chengdu, China.
Abstract
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. 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. 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. ChiCTR2500112222. Date of registration is November 11, 2025. Available at https://www.chictr.org.cn/showproj.html?proj=293381.
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BibTeX
@article{zou2026neoadjuvant,
title = {{Neoadjuvant transarterial chemoembolization, camrelizumab, and apatinib for centrally located hepatocellular carcinoma (NEO-CENTACT): study protocol for a phase II trial.}},
author = {Yang Zou and Junjun Tao and Zhijun Kuang and Diao Kong and Minghong Yao and Wei Peng},
journal = {Journal of gastrointestinal oncology},
year = {2026},
month = sep,
doi = {10.21037/jgo-2026-0841},
url = {https://europepmc.org/article/MED/42996577},
note = {CC BY-NC-ND},
}
RIS
TY - JOUR
TI - Neoadjuvant transarterial chemoembolization, camrelizumab, and apatinib for centrally located hepatocellular carcinoma (NEO-CENTACT): study protocol for a phase II trial.
AU - Yang Zou
AU - Junjun Tao
AU - Zhijun Kuang
AU - Diao Kong
AU - Minghong Yao
AU - Wei Peng
PY - 2026
DA - 2026/09/29
JO - Journal of gastrointestinal oncology
DO - 10.21037/jgo-2026-0841
UR - https://europepmc.org/article/MED/42996577
AB - 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. 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. 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. ChiCTR2500112222. Date of registration is November 11, 2025. Available at https://www.chictr.org.cn/showproj.html?proj=293381.
SN - 2078-6891
SN - 2219-679X
ER -