ArticleTrials2024
Neoadjuvant therapy of sequential TACE, camrelizumab, and apatinib for single huge hepatocellular carcinoma (NEO-START): study protocol for a randomized controlled trial.
Article in Trials, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers.
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Who cites it
9 citing papers in PubMed.
- Perioperative camrelizumab plus rivoceranib in resectable hepatocellular carcinoma: translating CARES-009 outcomes into a new therapeutic paradigm.Annals of medicine and surgery (2012) · 2026Article
- Longitudinal Monitoring of GRIm and HCC-GRIm Scores Reveals Immunologically Relevant Prognostic Indicators in Hepatocellular Carcinoma Undergoing TACE Plus ICIs and Anti-VEGF Antibodies/TKIs.Cancer medicine · 2026Article
- Gustave Roussy Immune Score Predicts Outcomes in Hepatocellular Carcinoma Treated with TACE and Immunotherapy.Journal of hepatocellular carcinoma · 2026Article
- Debates and progress in the management of intermediate-stage (BCLC stage B) hepatocellular carcinoma.iLIVER · 2025Review
- Neoadjuvant therapy: Dawn of reducing the high post-surgery recurrence rate of hepatocellular carcinoma.World journal of gastrointestinal surgery · 2025Review
- Comparison of textbook outcomes between laparoscopic and open liver resection for patients with hepatocellular carcinoma: a multicenter study.Surgical endoscopy · 2025Article
- Nomogram for predicting early cancer-related death due to recurrence after liver resection in hepatocellular carcinoma patients with Barcelona Clinic Liver Cancer (BCLC) stage B/C: a multicenter study.BMC gastroenterology · 2025Article
- Association of the Number of Concurrent Metabolic Syndrome Risk Factors with Textbook Outcomes Following Liver Resection for Patients with Hepatocellular Carcinoma: A Multicenter Study.Annals of surgical oncology · 2025Article
- Liver transplantation following two conversions in a patient with huge hepatocellular carcinoma and portal vein invasion: A case report.World journal of gastroenterology · 2024Article
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Authors and funding
11 authors.
Funding
Abstract
backgroundThe 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.
methodsThis 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. 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.
trial registrationwww.chitr.org.cn ChiCTR2300078086. Registered on November 28, 2023. Start recruitment: 1st January 2024. Expected completion of recruitment: 15th June 2025.
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