Evidence map›Paper›PMID 35739300›Full record

Trial reportBritish journal of cancer2022

A Phase II study of neoadjuvant axitinib for reducing the extent of venous tumour thrombus in clear cell renal cell cancer with venous invasion (NAXIVA).

Grant D Stewart, Sarah J Welsh, Stephan Ursprung, Ferdia A Gallagher, James O Jones, Jacqui Shields, Christopher G Smith, Thomas J Mitchell, Anne Y Warren, Axel Bex and 19 more

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in British journal of cancer, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03494816 (NAXIVA- Phase II Neoadjuvant Study of Axitinib for Reducing Extent of Venous Tumour Thrombus in Clear Cell Renal Cell Cancer With Venous Invasion), which is not on this map. Cited by 41 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
41citing papers in PubMed, 2 pooled it
8.5field-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.

NCT03494816 phase2completednot on this map

NAXIVA- Phase II Neoadjuvant Study of Axitinib for Reducing Extent of Venous Tumour Thrombus in Clear Cell Renal Cell Cancer With Venous Invasion

TypeinterventionalSponsorScottish Clinical Trials Research UnitRan2017 to 2020Enrolled24ConditionsRenal Cell Carcinoma, Metastatic Renal Cell Carcinoma, Non-metastatic Renal Cell CarcinomaArmsAxitinib Oral Tablet
3 · Its place in the literature

Who cites it

41 citing papers in PubMed, 2 syntheses or guidelines pooled it, 63 citations in OpenAlex.

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  13. Asian journal of pharmaceutical sciences · 2026
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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

29 authors at 11 institutions in 1 country.

Grant D StewartUniversity of Cambridge, Cambridge, UK. gds35@cam.ac.uk.ORCID http://orcid.org/0000-0003-3188-9140
Sarah J WelshUniversity of Cambridge, Cambridge, UK.
Stephan UrsprungUniversity of Cambridge, Cambridge, UK.
Ferdia A GallagherUniversity of Cambridge, Cambridge, UK.ORCID http://orcid.org/0000-0003-4784-5230
James O JonesUniversity of Cambridge, Cambridge, UK.
Jacqui ShieldsMRC Cancer Unit, University of Cambridge, Cambridge, UK.
Christopher G SmithCRUK Cambridge Institute, Cambridge, UK.ORCID http://orcid.org/0000-0001-7357-2737
Thomas J MitchellUniversity of Cambridge, Cambridge, UK.
Anne Y WarrenUniversity of Cambridge, Cambridge, UK.
Axel BexRoyal Free London NHS Foundation Trust, London, UK.
Ekaterini BoletiRoyal Free London NHS Foundation Trust, London, UK.
Jade CarruthersScottish Clinical Trials Research Unit, Public Health Scotland, Edinburgh, UK.
Tim EisenUniversity of Cambridge, Cambridge, UK.
Kate FifeCambridge University Hospitals NHS Foundation Trust, Cambridge, UK.
Abdel HamidBroomfield Hospital, Chelmsford, UK.
Alexander LairdWestern General Hospital, Edinburgh, UK.
Steve LeungWestern General Hospital, Edinburgh, UK.
Jahangeer MalikWestern General Hospital, Edinburgh, UK.
Iosif A MendichovszkyUniversity of Cambridge, Cambridge, UK.
Faiz MumtazRoyal Free London NHS Foundation Trust, London, UK.
Grenville OadesNHS Greater Glasgow and Clyde, Glasgow, UK.
Andrew N PriestUniversity of Cambridge, Cambridge, UK.
Antony C P RiddickCambridge University Hospitals NHS Foundation Trust, Cambridge, UK.
Balaji VenugopalNHS Greater Glasgow and Clyde, Glasgow, UK.
Michelle WelshScottish Clinical Trials Research Unit, Public Health Scotland, Edinburgh, UK.
Kathleen RiddleScottish Clinical Trials Research Unit, Public Health Scotland, Edinburgh, UK.
Lisa E M HopcroftScottish Clinical Trials Research Unit, Public Health Scotland, Edinburgh, UK.
NAXIVA Trial Group
Robert J JonesNHS Greater Glasgow and Clyde, Glasgow, UK.ORCID http://orcid.org/0000-0002-2904-6980
University of Cambridge · GBWestern General Hospital · GBRoyal Free London NHS Foundation Trust · GBCambridge University Hospitals NHS Foundation Trust · GBNHS Greater Glasgow and Clyde · GBPublic Health Scotland · GBBroomfield Hospital · GBRoyal Marsden Hospital · GBUniversity of Oxford · GBAlzheimer’s Research UK · GBKing's College London · GB

Funding

Cancer Research UK 16628Cancer Research UK 27150Cancer Research UK 27176Cancer Research UK 28667Medical Research Council MC_UP_1101/2Medical Research Council MC_UU_12022/5
6 · The paper itself

Abstract

backgroundSurgery for renal cell carcinoma (RCC) with venous tumour thrombus (VTT) extension into the renal vein (RV) and/or inferior vena cava (IVC) has high peri-surgical morbidity/mortality. NAXIVA assessed the response of VTT to axitinib, a potent tyrosine kinase inhibitor.

methodsNAXIVA was a single-arm, multi-centre, Phase 2 study. In total, 20 patients with resectable clear cell RCC and VTT received upto 8 weeks of pre-surgical axitinib. The primary endpoint was percentage of evaluable patients with VTT improvement by Mayo level on MRI. Secondary endpoints were percentage change in surgical approach and VTT length, response rate (RECISTv1.1) and surgical morbidity.

resultsIn all, 35% (7/20) patients with VTT had a reduction in Mayo level with axitinib: 37.5% (6/16) with IVC VTT and 25% (1/4) with RV-only VTT. No patients had an increase in Mayo level. In total, 75% (15/20) of patients had a reduction in VTT length. Overall, 41.2% (7/17) of patients who underwent surgery had less invasive surgery than originally planned. Non-responders exhibited lower baseline microvessel density (CD31), higher Ki67 and exhausted or regulatory T-cell phenotype.

conclusionsNAXIVA provides the first Level II evidence that axitinib downstages VTT in a significant proportion of patients leading to reduction in the extent of surgery. CLINICAL

trial registrationNCT03494816.

Indexed as

AxitinibCarcinoma, Renal CellKidney NeoplasmsThrombosisHumansNeoadjuvant TherapyNephrectomyRetrospective StudiesAxitinib

Identifiers

PMID35739300
PMCPMC9470559
OpenAlexW4283314142

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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.