Evidence map›Paper›PMID 40631456›Full record

Trial reportLiver international : official journal of the International Association for the Study of the Liver2025

Sunitinib as Second-Line Treatment in Advanced Intrahepatic Cholangiocarcinoma: Results From the SUN-CK GERCOR Phase II Trial.

Louis Gros, Mohamed Bouattour, Clément Dumont, Laëtitia Dahan, David Malka, Annemilaï Tijeras-Raballand, Armand De Gramont, Maxime Ronot, Chantal Dreyer, Cindy Neuzillet and 7 more

Registry-linked trialAbstract readClinical Trial, Phase IIMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Liver international : official journal of the International Association for the Study of the Liver, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01718327 (A Phase II Open-label Single Arm Study of Sunitinib in Patients With Advanced Cholangiocarcinoma), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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.

NCT01718327 phase2completednot on this map

A Phase II Open-label Single Arm Study of Sunitinib in Patients With Advanced Cholangiocarcinoma

TypeinterventionalSponsorGERCOR - Multidisciplinary Oncology Cooperative GroupRan2011 to 2016Enrolled53ConditionsUnresectable and Advanced CholangiocarcinomaArmsSunitinib
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Sunitinib as Second-Line Treatment in Advanced Intrahepatic Cholangiocarcinoma: Results From the SUN-CK GERCOR Phase II Trial.Liver international : official journal of the International Association for the Study of the Liver · 2025
    Trial
  2. 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

17 authors.

Louis GrosDepartment of Medical Oncology, Paris Saint-Joseph Hospital Group, Paris, France.ORCID 0000-0001-9331-5148
Mohamed BouattourDepartment of Liver Cancer and Innovative Therapy Unit, Hôpital Beaujon, Assistance Publique-Hôpitaux de Paris, AP-HP. Nord, Clichy, France; Université Paris Cité, Centre de Recherche Sur L'Inflammation (CRI), INSERM, U1149, CNRS, Paris, France.ORCID 0000-0002-3919-4135
Clément DumontMedical Oncology Department, Saint-Louis Hospital, Assistance Publique-Hôpitaux de Paris, AP-HP. Nord, Paris, France; Université Paris Cité, Centre de Recherche Sur L'Inflammation (CRI), INSERM, U1149, CNRS, Paris, France.
Laëtitia DahanService Oncologie Digestive & Hépato-Gastroentérologie, CHU Timone, Assistance Publique-Hôpitaux de Marseille (APHM) & Aix-Marseille-University (AMU), Marseille, France.
David MalkaDepartment of Medical Oncology, Institut Mutualiste Montsouris, Paris, France; Unité Dynamique des Cellules Tumorales, INSERM U1279, Université Paris-Saclay, Gustave Roussy, Villejuif, France; GERCOR, Paris, France.
Annemilaï Tijeras-RaballandOncoMEGA, Lamorlaye, France.
Armand De GramontAFR Oncology, Boulogne-Billancourt, France.
Maxime RonotDepartment of Radiology, Hôpital Beaujon, Assistance Publique-Hôpitaux de Paris, AP-HP. Nord, Clichy, France; Université Paris Cité, Centre de Recherche Sur L'Inflammation (CRI), INSERM, U1149, CNRS, Paris, France.ORCID 0000-0001-7464-3939
Chantal DreyerInstitut de Cancérologie et Radiothérapie Bretillien, Saint-Malo, France.
Cindy NeuzilletGastrointestinal Oncology, Medical Oncology Department, Institut Curie, Université Versailles Saint-Quentin-Université Paris-Saclay, Saint-Cloud, France; Molecular Oncology, PSL Research University, CNRS, UMR 144, Institut Curie, Paris, France.
Philippe BourgetDepartment of Clinical Pharmacy, Hôpital Necker-Enfants Malades, AP-HP, Paris, France.
Alexandra HadengueGERCOR-IRC, Paris, France.
Nelly RoldanGERCOR-IRC, Paris, France.
Marie-Line Garcia-LarnicolGERCOR-IRC, Paris, France.
Benoist ChibaudelDepartment of Medical Oncology, Hôpital Franco-Britannique - Fondation Cognacq-Jay, Cancérologie Paris Ouest, Levallois-Perret, France.
Eric RaymondDepartment of Medical Oncology, Paris Saint-Joseph Hospital Group, Paris, France.
Sandrine FaivreMedical Oncology Department, Saint-Louis Hospital, Assistance Publique-Hôpitaux de Paris, AP-HP. Nord, Paris, France; Université Paris Cité, Centre de Recherche Sur L'Inflammation (CRI), INSERM, U1149, CNRS, Paris, France.

Funding

Pfizer
6 · The paper itself

Abstract

BACKGROUND &

aimsAngiogenesis is critical in intrahepatic cholangiocarcinoma (ICC), a highly lethal cancer with limited treatment options. Sunitinib, a multi-receptor tyrosine kinase inhibitor, has strong antiangiogenic and antitumor effects. We aimed to evaluate the efficacy and tolerability of sunitinib as a second-line treatment in chemotherapy-pretreated patients with advanced ICC.

methodsThis open-label, single-arm, phase II trial was conducted across five French centres. Eligible patients were aged ≥ 18, had advanced ICC not suitable for curative surgery and had been pre-treated with gemcitabine and/or platinum. Patients received oral sunitinib at 37.5 mg daily. The primary endpoint was overall survival (OS), with secondary endpoints including progression-free survival (PFS), objective response rate (ORR), disease control rate (DCR) and safety. Tumour response was evaluated using RECIST v1.1, with exploratory analysis using Choi criteria. VEGF-A, VEGF-C and plasma sunitinib levels were measured.

resultsFifty-three patients were included. Median OS was 9.6 months (95% CI, 6.1-13.1), median PFS was 3.7 months (95% CI, 3.1-6.4), the ORR was 14% and the DCR was 84%. Grade 3-4 cytopenias occurred in 25% of patients, hypertension in 21% and fatigue in 19%. Higher baseline levels of VEGF-A and VEGF-C correlated with longer OS. Patients with dose reductions maintained adequate drug exposure. Choi criteria, applied to 24 patients, predicted response duration better than RECIST v1.1. Baseline tumour density, assessed in 14 patients, showed a potential association with treatment responses.

conclusionsSunitinib demonstrated efficacy and manageable toxicity as a second-line treatment in patients with advanced ICC previously treated with chemotherapy, suggesting it may represent a viable therapeutic option for this population.

trial registrationClinicalTrials.gov NCT01718327.

Indexed as

Angiogenesis InhibitorsAntineoplastic AgentsBile Duct NeoplasmsCholangiocarcinomaSunitinibAdultAgedAged, 80 and overFemaleFranceHumansMaleMiddle AgedProgression-Free SurvivalVascular Endothelial Growth Factor AAngiogenesis InhibitorsAntineoplastic AgentsSunitinibVascular Endothelial Growth Factor Aangiogenesis inhibitorsbiliary tract cancerChoi criteriatumour densityVEGF

Identifiers

PMID40631456
PMCPMC12239060

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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.