Evidence map›Paper›PMID 36450386›Full record

Trial reportJournal for immunotherapy of cancer2022

Nivolumab after selective internal radiation therapy for the treatment of hepatocellular carcinoma: a phase 2, single-arm study.

Manuel de la Torre-Aláez, Ana Matilla, Maria Varela, Mercedes Iñarrairaegui, Maria Reig, Jose Luis Lledó, Juan Ignacio Arenas, Sara Lorente, Milagros Testillano, Laura Márquez and 6 more

Erratum issued 2 registry-linked trialsOpen access · goldAbstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in Journal for immunotherapy of cancer, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to 2 registered trials, which are not on this map. Cited by 53 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
53citing papers in PubMed, 2 pooled it
9.4field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

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.

2 · The registry

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.

NCT03380130 phase2completednot on this map

A Multicenter, Open-label, Single-arm Study of the Safety and Antitumoral Efficacy of Nivolumab After SIRT Using SIR-Spheres for the Treatment of Patients With HepatoCellular Carcinoma That Are Candidates for Locoregional Therapies

TypeinterventionalSponsorClinica Universidad de Navarra, Universidad de NavarraRan2017 to 2020Enrolled41ConditionsHepatocellular CarcinomaArmsNivolumab, SIR-Spheres
NCT07293468 phase2 / phase3recruitingnot on this mapstarted 2024, after this paper: background citation

Comparison of Stereotactic Body Radiotherapy and Selective Internal Radiation Therapy in Combination With Immunotherapy for Locally-advanced, Unresectable Hepatocellular Carcinomas: an Open-label, Randomized Controlled Trial (BIIRTH)

TypeinterventionalSponsorTuen Mun HospitalRan2024 to 2034Enrolled106ConditionsHepatocellular Carcinoma (HCC)ArmsTransarterial chemoembolization (TACE), Stereotactic Body Radiation Therapy (SBRT), SIRT Yttrium-90, Atezolizumab & Bevacizumab
3 · Its place in the literature

Who cites it

53 citing papers in PubMed, 2 syntheses or guidelines pooled it, 73 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
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  5. Review
  6. Radiation-induced CD200Cellular & molecular immunology · 2026
    Article
  7. Review
  8. Article
  9. Review
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  11. Review
  12. Review
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  14. Review
  15. Improving surgical treatments for hepatocellular carcinoma.Nature reviews. Gastroenterology & hepatology · 2026
    Review
  16. Article
  17. Article
  18. Review
  19. Article
  20. Impact of LEAP-012 and EMERALD-1 in the management of HCC.JHEP reports : innovation in hepatology · 2026
    Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

16 authors at 10 institutions in 1 country.

Manuel de la Torre-AláezLiver Unit, Clinica Universidad de Navarra, Madrid, Spain.ORCID 0000-0002-1972-3933
Ana MatillaDigestive Diseases, Hospital General Universitario Gregorio Marañón, Madrid, Spain.
Maria VarelaLiver Unit, Hospital Universitario Central de Asturias, IUOPA, ISPA, FINBA, Universidad de Oviedo, Oviedo, Spain.
Mercedes IñarrairaeguiCentro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD), Spain.
Maria ReigCentro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD), Spain.
Jose Luis LledóCentro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD), Spain.
Juan Ignacio ArenasDigestive Diseases, Hospital Universitario Donostia, San Sebastian, Spain.
Sara LorenteLiver Unit, Hospital Clínico Lozano Blesa, IIS Aragón, Universidad de Zaragoza, Zaragoza, Spain.
Milagros TestillanoDigestive Diseases, Hospital Universitario de Cruces, Baracaldo, Spain.
Laura MárquezDigestive Diseases, Hospital General Universitario Gregorio Marañón, Madrid, Spain.
Leonardo Da FonsecaBCLC group, Liver Unit, Hospital Clinic, ICMDM, IDIBAPS, University of Barcelona, Barcelona, Spain.
Josepmaria ArgemíCentro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD), Spain.
Carlos Gómez-MartinMedical Oncology, Hospital Universitario 12 de Octubre, Madrid, Spain.
Macarena Rodriguez-FraileNuclear Medicine, Clinica Universidad de Navarra, Pamplona, Spain.ORCID 0000-0002-9069-7918
Jose I BilbaoInterventional Radiology, Clínica Universidad de Navarra, Pamplona, Spain.
Bruno SangroCentro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD), Spain bsangro@unav.es.
Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas · ESClinica Universidad de Navarra · ESHospital General Universitario Gregorio Marañón · ESBiogipuzkoa Health Research Institute · ESConsorci Institut D'Investigacions Biomediques August Pi I Sunyer · ESHospital de Cruces · ESHospital Universitario 12 De Octubre · ESInstituto Ramón y Cajal de Investigación Sanitaria · ESUniversidad de Oviedo · ESUniversidad de Zaragoza · ES

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeTo evaluate the safety and efficacy of selective internal radiation therapy (SIRT) in combination with a PD-1 inhibitor in patients with unresectable hepatocellular carcinoma (uHCC) and liver-only disease ineligible for chemoembolization. PATIENTS AND

methodsNASIR-HCC is a single-arm, multicenter, open-label, phase 2 trial that recruited from 2017 to 2019 patients who were naïve to immunotherapy and had tumors in the BCLC B2 substage (single or multiple tumors beyond the up-to-7 rule), or unilobar tumors with segmental or lobar portal vein invasion (PVI); no extrahepatic spread; and preserved liver function. Patients received SIRT followed 3 weeks later by nivolumab (240 mg every 2 weeks) for up to 24 doses or until disease progression or unacceptable toxicity. Safety was the primary endpoint. Secondary objectives included objective response rate (ORR), time to progression (TTP), and overall survival (OS).

results42 patients received SIRT (31 BCLC-B2, 11 with PVI) and were followed for a median of 22.2 months. 27 patients discontinued and 1 never received Nivolumab. 41 patients had any-grade adverse events (AE) and 21 had serious AEs (SAE). Treatment-related AEs and SAEs grade 3-4 occurred in 8 and 5 patients, respectively. Using RECIST 1.1 criteria, ORR reported by investigators was 41.5% (95% CI 26.3% to 57.9%). Four patients were downstaged to partial hepatectomy. Median TTP was 8.8 months (95% CI 7.0 to 10.5) and median OS was 20.9 months (95% CI 17.7 to 24.1).

conclusionsThe combination of SIRT and nivolumab has shown an acceptable safety profile and signs of antitumor activity in the treatment of patients with uHCC that were fit for SIRT. TRIAL REGISTRATION NUMBER: NCT03380130.

Indexed as

Carcinoma, HepatocellularLiver NeoplasmsHumansNivolumabThiamineNivolumabThiaminethiamine triphosphoratecytotoxicity, immunologicimmunotherapyliver neoplasmsprogrammed cell death 1 receptorradioimmunotherapy

Identifiers

PMID36450386
PMCPMC9716796
OpenAlexW4310580567

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

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.