ArticleCancer immunology, immunotherapy : CII2023
Real-world cohort study of PD-1 blockade plus lenvatinib for advanced intrahepatic cholangiocarcinoma: effectiveness, safety, and biomarker analysis.
Article in Cancer immunology, immunotherapy : CII, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03892577 (Real-world Study for Targeted Therapy and Immunotherapy in Patients With Advanced Hepatobiliary Tumors), which is not on this map. Cited by 18 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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.
Real-world Study for Targeted Therapy and Immunotherapy in Patients With Advanced Hepatobiliary Tumors: a Multi-centers, Open-assess Observational Study.
Who cites it
18 citing papers in PubMed, 23 citations in OpenAlex.
- Chemotherapy combined with regorafenib and immune checkpoint inhibitors as a first-line treatment for patients with advanced biliary tract cancer: a single arm phase II trial.Frontiers in immunology · 2024Trial
- Comprehensive Genomic Profiles of Patients With Biliary Tract Cancer.Cancer medicine · 2026Article
- Comparative predictive value of immunotherapy biomarkers: a systematic review and network meta-analysis.International journal of surgery (London, England) · 2026Article
- FGF1-FGFR2 axis regulated by nuclear receptor RORγ represents an effective strategy in intrahepatic cholangiocarcinoma.Cell death discovery · 2025Article
- Perioperative and precision strategies in resectable intrahepatic cholangiocarcinoma.Global health & medicine · 2025Article
- Precision medicine for advanced biliary tract cancer in China: current status and future perspectives.Frontiers of medicine · 2025Review
- Efficacy and safety of local-regional therapy combined with chemotherapy, immune checkpoint inhibitors and lenvatinib as first-line treatment in advanced intrahepatic cholangiocarcinoma: a multicenter retrospective cohort study.Cancer immunology, immunotherapy : CII · 2025Article
- Hepatic arterial infusion chemotherapy (HAIC) plus Lenvatinib and PD-1 inhibitors versus systemic chemotherapy for unresectable intrahepatic cholangiocarcinoma.Discover oncology · 2025Article
- Comparison analysis of ICIs and chemotherapy combined with or without lenvatinib as first-line treatment of unresectable intrahepatic cholangiocarcinoma.BMC cancer · 2025Article
- Adrenomedullin Inhibits the Efficacy of Combined Immunotherapy and Targeted Therapy in Biliary Tract Cancer by Disrupting Endothelial Cell Functions.Journal of cellular and molecular medicine · 2025Article
- Isocitrate dehydrogenase 1 gene mutations: a case review unveiling its biological impact on disease progression, prognosis and treatment in Chilean patients.BJR case reports · 2025Review
- The Efficacy and Safety of Hepatic Artery Infusion Chemotherapy Combined with Lenvatinib and Programmed Death (PD)-1 Inhibitors for Unresectable Intrahepatic Cholangiocarcinoma: A Retrospective Study.Current oncology (Toronto, Ont.) · 2025Article
- Prognostic value of PD-L1 expression on tumor-infiltrating immune cells and neutrophil-to-lymphocyte ratio in patients with biliary tract cancer.Frontiers in immunology · 2025Article
- Nab-paclitaxel-based chemotherapy with or without anti-PD-(L)1 immunotherapy as a second-line treatment for advanced biliary tract cancer: a real-world retrospective study.Therapeutic advances in medical oncology · 2025Article
- Efficacy and safety of cadonilimab combined with AG chemotherapy in patients with unresectable locally advanced or metastatic pancreatic ductal adenocarcinoma: a retrospective real-world study.Frontiers in immunology · 2025Article
- Tumor budding in pre-neoadjuvant biopsy and post-neoadjuvant resection specimens is associated with poor prognosis in intrahepatic cholangiocarcinoma-a cohort study of 147 cases by modified ITBCC criteria.Virchows Archiv : an international journal of pathology · 2024Article
- Emerging biomarkers for immunotherapy response in biliary tract cancers: a comprehensive review of immune checkpoint inhibitor strategies.Biomarkers in medicine · 2024Review
- The fibrosis-4 index is a prognostic factor for cholangiocarcinoma patients who received immunotherapy.Frontiers in immunology · 2024Article
Corrections and comments
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Authors and funding
16 authors at 2 institutions in 1 country.
Funding
Abstract
backgroundIn clinical practice, some patients with advanced intrahepatic cholangiocarcinoma (ICC) cannot tolerate or refuse chemotherapy due to the toxicity, necessitating alternative treatments. PD-1 blockade combined with lenvatinib showed promising results in phase II studies with small sample size, but there is a lack of data on the routine use with this regimen. This study aimed to evaluate the effectiveness and safety of the regimen in patients with advanced ICC, and to identify predictors for treatment response and prognosis.
methodsWe conducted a retrospective cohort study of patients treated with PD-1 inhibitors plus lenvatinib for advanced ICC between July 2017 and August 2022. The study endpoints were progression-free survival (PFS), overall survival (OS), objective response rate (ORR), disease control rate (DCR), and safety. Biomarker analysis for CA19-9 and PD-L1 expression was performed. Exploratory analysis for genetic alternation was conducted.
resultsThe study included 103 patients. It demonstrated a median PFS of 5.9 months and a median OS of 11.4 months. ORR was 18.4% and DCR was 80.6%. The incidence of grade 3 or 4 adverse events was 50.5%. Positive PD-L1 expression (TPS ≥ 1%) was associated with higher ORR (P = 0.013) and prolonged PFS (P = 0.023). Elevated CA19-9 (> 37 U/ml) was associated with decreased ORR (P = 0.019), poorer PFS (P = 0.005) and OS (P = 0.034). Patients with IDH1 mutations exhibited a favorable response to the treatment (P = 0.011), and patients with TP53 mutations tended to have worse OS (P = 0.031).
conclusionsPD-1 blockade plus lenvatinib is effective and safe in routine practice. PD-L1 expression and CA19-9 level appear to predict the treatment efficacy. IDH1 mutations might indicate a better treatment response. CLINICAL
trial registrationNCT03892577.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.