Evidence map›Paper›PMID 41118066›Full record

Trial reportAnnals of surgical oncology2026

Treatment Intensification with Hepatic Arterial Infusion Chemotherapy in Patients with Liver-Only Colorectal Metastases Still Unresectable After Systemic Induction Chemotherapy: Exploratory Findings From a Prematurely Closed Multicenter Randomized Phase II Study: SULTAN UCGI 30/PRODIGE 53 (NCT03164655).

Alice Boilève, Franck Audemar, Eric Dupont-Bierre, Samuel Le Sourd, Ayhan Ulusakarya, Marion Chauvenet, Asmahame Benmaziame, Mathilde Wagner, Diane Goere, Clarisse Dromain and 5 more

Registry-linked trialAbstract readClinical Trial, Phase IIRandomized Controlled TrialMulticenter Study
PubMed Publisher
In one paragraph

Trial report in Annals of surgical oncology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03164655 (A Randomized Phase II Study Comparing Treatment Intensification With CIAH Plus Systemic Chemotherapy to Systemic Chemotherapy Alone in Patients With Liver-only Colorectal Metastases Considered Still Non Resectable After at Least Two Months of Systemic Induction Chemotherapy), which is not on this 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.

NCT03164655 phase2completednot on this map

A Randomized Phase II Study Comparing Treatment Intensification With CIAH Plus Systemic Chemotherapy to Systemic Chemotherapy Alone in Patients With Liver-only Colorectal Metastases Considered Still Non Resectable After at Least Two Months of Systemic Induction Chemotherapy

TypeinterventionalSponsorUNICANCERRan2018 to 2021Enrolled20ConditionsColorectal Cancer MetastaticArmsOxaliplatin, Cetuximab, Bevacizumab, Panitumumab, Irinotecan, Leucovorin, 5-Fluorouracil
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. 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

15 authors.

Alice BoilèveDepartment of Cancer Medicine, Gustave Roussy, Villejuif, France.
Franck AudemarDepartment of Hepatogastroenterology, Centre hospitalier Côte Basque, Bayonne, France.
Eric Dupont-BierreDepartment of Digestive Surgery, CHP Saint Grégoire, Saint-Grégoire, France.
Samuel Le SourdDepartment of Medical Oncology, Centre Eugène-Marquis, Rennes, France.
Ayhan UlusakaryaDepartment of Medical Oncology, Hôpital Paul Brousse, Villejuif, France.
Marion ChauvenetDepartment of Hepatogastroenterology, Hospices Civils de Lyon, Lyon, France.
Asmahame BenmaziameDepartment of Digestive Surgery, Hôpital Foch, Suresnes, France.
Mathilde WagnerDepartment of Radiology, Hôpital Pitié Salpétrière, APHP, Sorbonne Université, Paris, France.
Diane GoereDepartment of Surgical Oncology, CHU Saint Louis, Paris, France.
Clarisse DromainDepartment of Radiology, Lausanne University Hospital and University of lausanne, Lausanne, Switzerland.
Maximiliano GelliDepartment of Surgical Oncology, Gustave Roussy, Villejuif, France.
Veronica PezzellaR&D Unicancer, Paris, France.
Baptiste BonnetDepartment of interventional radiology, Gustave Roussy, Villejuif, France.
Marie-Laure TanguyDepartment of Biostatistics and Epidemiology, Gustave Roussy, University Paris-Saclay, Villejuif, France.
Valérie BoigeDepartment of Cancer Medicine, Gustave Roussy, Villejuif, France. valerie.boige@gustaveroussy.fr.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundHepatic arterial infusion (HAI) oxaliplatin represents a promising treatment option in patients with unresectable liver-only colorectal metastases (CRLM).

methodsIn this randomized phase II study, we evaluated the efficacy of an intensification strategy based on HAI oxaliplatin combined with systemic chemotherapy (sys-CT) as a salvage treatment in patients with CRLM still unresectable after first-line induction sys-CT. The primary objective was conversion to resection/ablation (CTR). A real-life retrospective cohort of consecutive patients treated with HAI oxaliplatin + sys-CT in the same setting was also analyzed.

resultsThe study was stopped prematurely because of slow enrollment. Among 26 patients (13 men [50%]; median age 60 years) enrolled in 2018-2021, 11 were randomized in arm A (HAI + sys-CT, percutaneously placed catheters) and nine in arm B (sys-CT). CRLM were synchronous in 89% of patients, and 55% had RAS mutations. The CTR was 64% (7/11) in arm A and 22% (2/9) in arm B (odds ratio 0.16; 95% confidence interval 0.02-1.2; p = 0.09). Objective tumor response was 80% (8/10) in arm A and 11% (1/9) in arm B. Median overall survival was not reached in arm A versus 16.6 months in arm B (p = 0.008). Progression-free survival was significantly longer in arm A (12.6 vs. 4.37 months, p = 0.002). In the retrospective cohort of 35 patients, objective tumor response and CTR were 64% and 34%, respectively. Overall, HAI-related toxicity was manageable.

conclusionsBecause the number of enrolled patients was lower than expected, our study could not confirm that salvage HAI combined with sys-CT improved CTR and survival outcomes compared with Sys-CT alone. However, these encouraging exploratory results warrant further prospective studies.

trial registrationClinicalTrials.gov, (NCT03164655). Trial registration date: 11th May 2017. https://clinicaltrials.gov/ct2/show/NCT03164655.

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsColorectal NeoplasmsInduction ChemotherapyLiver NeoplasmsSalvage TherapyAdultAgedEarly Termination of Clinical TrialsFemaleFollow-Up StudiesHepatic ArteryHumansInfusions, Intra-ArterialMaleMiddle AgedOxaliplatinOxaliplatinColorectal cancerHepatic arterial infusionLiver metastasesLiver resectionOxaliplatin

Identifiers

PMID41118066

What OpenQuestion holds

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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.