ArticleEClinicalMedicine2025
Donafenib and sintilimab combined with hepatic arterial infusion chemotherapy for unresectable hepatocellular carcinoma: a prospective, single-arm phase II trial (DoHAICs study).
Article in EClinicalMedicine, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05166772 (Efficacy and Safety of Donafenib Combine With Sintilimab and HAIC), which is not on this map. Cited by 9 papers, 4 of them syntheses that pooled it.
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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.
Efficacy and Safety of Donafenib Combine With Sintilimab and HAIC (Hepatic Artery Infusion Chemotherapy，HAIC） in the First-line Treatment of Unresectable Hepatocellular Carcinoma
Who cites it
9 citing papers in PubMed, 4 syntheses or guidelines pooled it.
- Conversion hepatectomy and survival in initially unresectable hepatocellular carcinoma: a systematic review and meta-analysis with quantitative bias analysis.World journal of surgical oncology · 2026Pooled it
- Comparative efficacy of combination regimens based on interventional therapy and immune checkpoint inhibitors (ICIs) in patients with intermediate- and advanced-stage hepatocellular carcinoma: a systematic review, meta-analysis, and network meta-analysis.Cancer immunology, immunotherapy : CII · 2026Pooled it
- Pooled it
- Locoregional therapy combined with targeted therapy and immunotherapy for hepatocellular carcinoma with portal vein tumor thrombosis: a systematic review and meta-analysis.Scientific reports · 2025Pooled it
- Interventional Management of Patients with Hepatocellular Carcinoma and Portal Vein Tumor Thrombosis: Are There Differences Between East and West?Current oncology reports · 2026Review
- Chinese expert consensus on conversion and perioperative therapy of primary liver cancer (2024 edition).Hepatobiliary surgery and nutrition · 2026Review
- Schisandrin A suppresses hepatocellular carcinoma and sensitizes to sorafenib via modulating retinol metabolism.American journal of cancer research · 2026Article
- Concurrent expression of glucose-6-phosphate dehydrogenase and secreted phosphoprotein 1 characterizes an aggressive and immunosuppressive tumor state in hepatocellular carcinoma.Frontiers in cell and developmental biology · 2026Article
- Navigating the complexities: challenges and opportunities in conversion therapy for advanced hepatocellular carcinoma.Clinical and experimental medicine · 2025Review
Corrections and comments
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Authors and funding
19 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Background: Donafenib demonstrates superior survival benefits and safety compared to sorafenib. Hepatic arterial infusion chemotherapy (HAIC) proves effective for large unresectable hepatocellular carcinoma (uHCC) over transarterial chemoembolization. This study aims to investigate the safety and efficacy of combining HAIC with donafenib and sintilimab in patients with uHCC. Methods: This prospective single-arm study enrolled patients with histologically confirmed uHCC and no prior systemic treatment from December 2021 to May 2023 in Tianjin Medical University Cancer Institute and Hospital, China. Participants received donafenib, sintilimab and HAIC until disease progression or unacceptable toxicity. The primary endpoint was the objective response rate (ORR). The secondary endpoints included overall survival (OS), event-free survival (EFS), disease control rate (DCR) and safety. The study was registered at ClinicalTrials.gov, NCT05166772. Findings: A total of 36 patients were enrolled, and the median follow-up was 16 months. ORR were 58.3% and 80.6% per RECIST 1.1 and mRECIST respectively, and DCR were all 94.4%. 24-month OS rate was 59.6%. Median EFS was 15.3 months. The conversion success rate was 50.0%, 18 patients underwent hepatectomy, seven (38.9%) achieved pathological complete response, and nine (50.0%) achieved major pathological responses. Median OS was not achieved (NA) in the surgical group vs. 14.3 months (95% CI 12.1-NA) in the non-surgical group ( Interpretation: Combining HAIC with donafenib and sintilimab demonstrates promising clinical outcomes while maintaining acceptable toxicity, making it a potential strategy for conversion therapy. Funding: Tianjin Key Medical Discipline (Specialty) Construction Project (TJYXZDXK-009A) and Precision Treatment Project of Surgical Oncology of Tianjin Medical University Cancer Institute and Hospital (No. ZLWKJZZL14).
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