ArticleFrontiers in oncology2022
Safety and efficacy of radiotherapy combined with lenvatinib plus PD-1 inhibitors as neo-adjuvant therapy in hepatocellular carcinoma with portal vein thrombus: protocol of an open-label, single-arm, prospective, multi-center phase I trial.
Article in Frontiers in oncology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05225116 (Safety and Efficacy of Lenvatinib and Anti-PD1 Antibody Combined With Radiotherapy Neoadjuvant Treatment for Resectable Hepatocellular Carcinoma With PVTT,Prospective, Multicenter, Single-arm Study), which is not on this map. Cited by 7 papers.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Safety and Efficacy of Lenvatinib and Anti-PD1 Antibody Combined With Radiotherapy Neoadjuvant Treatment for Resectable Hepatocellular Carcinoma With PVTT,Prospective, Multicenter, Single-arm Study
Who cites it
7 citing papers in PubMed, 5 citations in OpenAlex.
- Neoadjuvant therapy for hepatocellular carcinoma: emerging combinations and biomarker challenges.Frontiers in immunology · 2026Review
- Neoadjuvant systemic therapy for hepatocellular carcinoma: challenges and opportunities-a narrative review.Hepatobiliary surgery and nutrition · 2025Review
- Neoadjuvant therapy: Dawn of reducing the high post-surgery recurrence rate of hepatocellular carcinoma.World journal of gastrointestinal surgery · 2025Review
- Radiomics of Dynamic Contrast-Enhanced MRI for Predicting Radiation-Induced Hepatic Toxicity After Intensity Modulated Radiotherapy for Hepatocellular Carcinoma: A Machine Learning Predictive Model Based on the SHAP Methodology.Journal of hepatocellular carcinoma · 2025Article
- Neoadjuvant therapy for hepatocellular carcinoma-priming precision innovations to transform HCC treatment.Frontiers in surgery · 2025Review
- Comparative analysis of external beam radiotherapy versus portal vein stent implantation combined with local and systemic therapy in hepatocellular carcinoma patients with portal vein tumor thrombus: a real-world retrospective study.Frontiers in oncology · 2025Article
- Review
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Authors and funding
12 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Background: Surgical resection is a mainstay to treat hepatocellular carcinoma (HCC) with portal vein tumor thrombus (PVTT) in east Asia. However, the postoperative recurrence rate is high. It is necessary to explore neo-adjuvant therapy to increase the surgical resection rate and improve overall survival. Evidence has shown that lenvatinib combined with PD-1 inhibitors is safe and effective in the treatment of advanced unresectable HCC. Radiotherapy is also an effective treatment method for PVTT and has a synergistic effect in combination with PD-1 inhibitors. Surgical resection after Lenvatinib and sintilimab combined with radiotherapy as a neoadjuvant treatment regimen may be a new exploration of HCC with PVTT, but there were not any reported. Methods: This open-label, single-arm, prospective, multi-center Phase I trial will enroll 20 HCC patients with PVTT who have a resectable primary tumor and no extra-hepatic metastasis. Eligible patients will be given radiotherapy, 3Gy*10 fraction, and will receive lenvatinib 8-12mg once daily and sintilimab 200mg once every three weeks. Surgical resection will be performed 6-8 weeks after radiotherapy. The primary endpoint is safety (number of patients ≥3G TRAE) and the number of patients who complete pre-op treatment and proceed to surgery. The secondary study endpoints include Major Pathological Response (MPR), 1-year tumor recurrence-free rate, Objective Response Rate (ORR), Imaging-Pathology Concordance Rate (IPCR), PVTT regression rate, Median Overall Survival (OS) and Recurrence Free Survival (RFS). Discussion: This trial may confirm that surgical resection following intensive neoadjuvant therapy can provide a safe and efficient regimen for BCLC stage C patients with PVTT. Clinical trial registration: https://clinicaltrials.gov/, identifier (NCT05225116).
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