Evidence map›Paper›PMID 41725391›Full record

Trial reportAlimentary pharmacology & therapeutics2026

Clinical Trial: Early Nivolumab Addition to Regorafenib in Patients With Hepatocellular Carcinoma in Second-Line (The GOING Trial).

Marco Sanduzzi-Zamparelli, Ana Matilla, José Luis Lledo, Sergio Muñoz-Martínez, María Varela, Mercedes Iñarrairaegui, Christie Perelló, Beatriz Mínguez, Neus Llarch, Laura Márquez and 15 more

Abstract readClinical Trial, Phase IIClinical Trial, Phase I
In one paragraph

Trial report in Alimentary pharmacology & therapeutics, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Immunotherapy Rechallenge in HCC: A Second Chance for Response?Liver international : official journal of the International Association for the Study of the Liver · 2026
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

25 authors.

Marco Sanduzzi-ZamparelliBCLC Group, Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Barcelona, Spain.ORCID https://orcid.org/0000-0003-3795-3705
Ana MatillaCentro de Investigación Biomédica en Red en Enfermedades Hepáticas y Digestivas (CIBEREHD), Madrid, Spain.
José Luis LledoCentro de Investigación Biomédica en Red en Enfermedades Hepáticas y Digestivas (CIBEREHD), Madrid, Spain.
Sergio Muñoz-MartínezBCLC Group, Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Barcelona, Spain.
María VarelaLiver Unit, Gastroenterology Department, Hospital Universitario Central de Asturias, Oviedo, Spain.ORCID https://orcid.org/0000-0003-4288-2593
Mercedes IñarrairaeguiCentro de Investigación Biomédica en Red en Enfermedades Hepáticas y Digestivas (CIBEREHD), Madrid, Spain.
Christie PerellóCentro de Investigación Biomédica en Red en Enfermedades Hepáticas y Digestivas (CIBEREHD), Madrid, Spain.ORCID https://orcid.org/0000-0003-0234-2330
Beatriz MínguezCentro de Investigación Biomédica en Red en Enfermedades Hepáticas y Digestivas (CIBEREHD), Madrid, Spain.
Neus LlarchBCLC Group, Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Barcelona, Spain.ORCID https://orcid.org/0000-0003-3209-0453
Laura MárquezGastroenterology and Hepatology Department, Hospital General Universitario Gregorio Marañón, Madrid, Spain.
Antonio GuerreroCentro de Investigación Biomédica en Red en Enfermedades Hepáticas y Digestivas (CIBEREHD), Madrid, Spain.ORCID https://orcid.org/0009-0007-7989-7808
Gemma IserteBCLC Group, Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Barcelona, Spain.
Andrés Castaño-GarcíaLiver Unit, Gastroenterology Department, Hospital Universitario Central de Asturias, Oviedo, Spain.
Laura CarriónGastroenterology and Hepatology Department, Hospital General Universitario Gregorio Marañón, Madrid, Spain.
Marta FortunyBCLC Group, Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Barcelona, Spain.ORCID https://orcid.org/0000-0003-4413-7909
Jordi RimolaBCLC Group, Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Barcelona, Spain.
Ángeles García-CriadoBCLC Group, Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Barcelona, Spain.
Gema DomenechMedical Statistics Core Facility, IDIBAPS-Hospital Clínic, Barcelona, Spain.
Ferran TorresMedical Statistics Core Facility, IDIBAPS-Hospital Clínic, Barcelona, Spain.
José Rios-GuillermoMedical Statistics Core Facility, IDIBAPS-Hospital Clínic, Barcelona, Spain.
Loreto BoixBCLC Group, Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Barcelona, Spain.
Esther SamperBCLC Group, Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Barcelona, Spain.
Àngels KatebFundació Clínic per a la Recerca Biomèdica-IDIBAPs, Barcelona, Spain.
Jordi BruixBCLC Group, Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Barcelona, Spain.
Maria ReigBCLC Group, Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Barcelona, Spain.

Funding

Bayer HealthCare Pharmaceuticals IncPharmaceuticals Bayer
6 · The paper itself

Abstract

BACKGROUND &

aimsHighly effective second-line treatments for hepatocellular carcinoma remain an unmet need. The GOING investigator-initiated Phase I/IIa trial evaluated regorafenib plus nivolumab (add-on) in patients who progressed on sorafenib (Cohort-A) or discontinued atezolizumab-bevacizumab (Cohort-B).

methodsPatients received regorafenib for two 28-day cycles, adding nivolumab in cycle 3, until unacceptable adverse events, symptomatic progression, withdrawal or death. Primary endpoint was safety. Secondary endpoints included overall survival, time to progression, post-progression survival, objective response rate and incidence of new-extrahepatic-spread.

resultsOf 85 patients screened, 67 were enrolled (75.5% BCLC-C). All experienced adverse events and 9% led to discontinuation. Severe treatment-related adverse events occurred in 28.4% overall, 32.1% in Cohort-A, and 14.3% in Cohort-B. Median overall survival was 20.0 (95% CI 11-37) months, with 40.6% survival at 36 months. In Cohort-A, median overall survival was 25 (95% CI 14-39) months with 45% survival at 36 months, while Cohort-B median overall survival was 8 (95% CI 4-NE) months with 28.6% survival at 24 months. Objective response rate was 16.4%; median time to progression and post-progression survival were 5 (95% CI 4-9) months and 14 (95% CI 8-33) months. Intrahepatic growth was the most common progression pattern, followed by new-extrahepatic-spread.

conclusionsThe add-on strategy of regorafenib plus nivolumab in second-line had manageable safety and significant clinical activity with a noteworthy median overall survival of 20 months. Among those progressing on sorafenib, 45% were alive at 3 years. These findings support further evaluation with mechanism-guided trials after progression on immunotherapy.

trial registrationEudraCT number: 2019-003108-10; https://www.clinicaltrialsregister.eu.

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsCarcinoma, HepatocellularLiver NeoplasmsNivolumabPhenylurea CompoundsPyridinesAdultAgedAged, 80 and overFemaleHumansMaleMiddle AgedTreatment OutcomeNivolumabPhenylurea CompoundsPyridinesregorafenibimmunotherapyliver cancersystemic therapytyrosine kinase‐inhibitor

Identifiers

PMID41725391
PMCPMC12982644

What OpenQuestion holds

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LicenceCC BY-NC
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Registered trials

None linked

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.