Evidence map›Paper›PMID 36343995›Full record

ArticleBMJ open2022

Study protocol for locoregional precision treatment of hepatocellular carcinoma with transarterial chemoembolisation (TACTida), a clinical study: idarubicin dose selection, tissue response and survival.

Sofi Sennefelt Nyman, Håkan Ahlström, Angeliki Dimopoulou Creusen, David Dahlgren, Mikael Hedeland, Femke Heindryckx, Ulf Johnson, Jaafar Khaled, Fredrik Kullenberg, Rickard Nyman and 7 more

Open access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in BMJ open, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
0.8field-weighted citation impact, top 28% 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.

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

4 citing papers in PubMed, 6 citations in OpenAlex.

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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

17 authors at 2 institutions in 2 countries.

Sofi Sennefelt NymanDepartment of Surgical Sciences, Section of Radiology, Uppsala University, Uppsala, Sweden sofi_nyman@hotmail.com.ORCID 0000-0002-8911-2927
Håkan AhlströmDepartment of Surgical Sciences, Section of Radiology, Uppsala University, Uppsala, Sweden.
Angeliki Dimopoulou CreusenDepartment of Surgical Sciences, Section of Radiology, Uppsala University, Uppsala, Sweden.
David DahlgrenDepartment of Pharmaceutical Biosciences, Uppsala University, Uppsala, Sweden.
Mikael HedelandDepartment of Medicinal Chemistry, Analytical Pharmaceutical Chemistry, Uppsala University, Uppsala, Sweden.
Femke HeindryckxDepartment of Medical Cell Biology, Uppsala University, Uppsala, Sweden.
Ulf JohnsonDepartment of Surgical Sciences, Section of Radiology, Uppsala University, Uppsala, Sweden.
Jaafar KhaledDepartment of Medical Cell Biology, Uppsala University, Uppsala, Sweden.
Fredrik KullenbergDepartment of Pharmaceutical Biosciences, Uppsala University, Uppsala, Sweden.
Rickard NymanDepartment of Surgical Sciences, Section of Radiology, Uppsala University, Uppsala, Sweden.
Fredrik RorsmanDepartment of Medical Sciences, Uppsala University, Uppsala, Sweden.
Reza SheikhiDepartment of Medical Sciences, Uppsala University, Uppsala, Sweden.
Ulrika S H SimonssonDepartment of Pharmaceutical Biosciences, Uppsala University, Uppsala, Sweden.
Erik SjögrenDepartment of Pharmaceutical Biosciences, Uppsala University, Uppsala, Sweden.
Alkwin WandersDepartment of Pathology, Aalborg University Hospital, Aalborg, Denmark.
Hans LennernäsDepartment of Pharmaceutical Biosciences, Uppsala University, Uppsala, Sweden.
Charlotte Ebeling BarbierDepartment of Surgical Sciences, Section of Radiology, Uppsala University, Uppsala, Sweden.
Uppsala University · SEAalborg University Hospital · DK

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionHepatocellular carcinoma (HCC) is a common cause of cancer-related death, often detected in the intermediate stage. The standard of care for intermediate-stage HCC is transarterial chemoembolisation (TACE), where idarubicin (IDA) is a promising drug. Despite the fact that TACE has been used for several decades, treatment success is unpredictable. This clinical trial has been designed believing that further improvement might be achieved by increasing the understanding of interactions between local pharmacology, tumour targeting, HCC pathophysiology, metabolomics and molecular mechanisms of drug resistance. METHODS AND ANALYSIS: The study population of this single-centre clinical trial consists of adults with intermediate-stage HCC. Each tumour site will receive TACE with two different IDA doses, 10 and 15 mg, on separate occasions. Before and after each patient's first TACE blood samples, tissue and liquid biopsies, and positron emission tomography (PET)/MRI will be performed. Blood samples will be used for pharmacokinetics (PK) and liver function evaluation. Tissue biopsies will be used for histopathology analyses, and culturing of primary organoids of tumour and non-tumour tissue to measure cell viability, drug response, multiomics and gene expression. Multiomics analyses will also be performed on liquid biopsies. PET/MRI will be used to evaluate tumour viability and liver metabolism. The two doses of IDA will be compared regarding PK, antitumour effects and safety. Imaging, molecular biology and multiomics data will be used to identify HCC phenotypes and their relation to drug uptake and metabolism, treatment response and survival. ETHICS AND DISSEMINATION: Participants give informed consent. Personal data are deidentified. A patient will be withdrawn from the study if considered medically necessary, or if it is the wish of the patient. The study has been approved by the Swedish Ethical Review Authority (Dnr. 2021-01928) and by the Medical Product Agency, Uppsala, Sweden. TRIAL REGISTRATION NUMBER: EudraCT number: 2021-001257-31.

Indexed as

Carcinoma, HepatocellularChemoembolization, TherapeuticLiver NeoplasmsHumansIdarubicinTreatment OutcomeIdarubicinGastroenterologyGastrointestinal imagingHepatology

Identifiers

PMID36343995
PMCPMC9644353
OpenAlexW4308435255

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

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.