Evidence map›Paper›PMID 31801872›Full record

Trial reportGut2020

Randomised, multicentre prospective trial of transarterial chemoembolisation (TACE) plus sorafenib as compared with TACE alone in patients with hepatocellular carcinoma: TACTICS trial.

Masatoshi Kudo, Kazuomi Ueshima, Masafumi Ikeda, Takuji Torimura, Nobukazu Tanabe, Hiroshi Aikata, Namiki Izumi, Takahiro Yamasaki, Shunsuke Nojiri, Keisuke Hino and 18 more

3 registry-linked trialsOpen access · hybridAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Gut, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 468 papers, 10 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
468citing papers in PubMed, 10 pooled it
41.8field-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.

NCT01217034 phase2unknown statusnot on this map

Phase II Study: Transcatheter Arterial Chemoembolization Therapy In Combination With Sorafenib (TACTICS)

TypeinterventionalSponsorKindai UniversityRan2010 to 2018Enrolled228ConditionsHepatocellular Carcinoma, Unresectable Hepatocellular Carcinoma, Carcinoma, Hepatocellular, Liver NeoplasmArmsTACE with sorafenib, TACE alone
NCT04974281 early_phase1unknown statusnot on this mapstarted 2021, after this paper: background citation

Efficacy and Safety of PD-1 Antibody and Lenvatinib Plus TACE on Downstaging Hepatocellular Carcinoma With BCLC B/C

TypeinterventionalSponsorFudan UniversityRan2021 to 2022Enrolled50ConditionsHepatocellular CarcinomaArmsPD-1 and Lenvatinib Plus TACE
NCT05171166 phase2 / phase3terminatednot on this mapstarted 2021, after this paper: background citation

Neoadjuvant HAIC of TACE Plus Donafenib in BCLC B Stage Hepatocellular Carcinoma Out Up-to-seven: a Multi-center Randomized Controlled Trial.

TypeinterventionalSponsorPeking UniversityRan2021 to 2025Enrolled18ConditionsHepatocellular CarcinomaArmsHAIC, TACE, FOLFOX, cTACE or DEB-TACE, Donafenib
3 · Its place in the literature

Who cites it

468 citing papers in PubMed, 10 syntheses or guidelines pooled it, 694 citations in OpenAlex.

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408 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

28 authors at 20 institutions in 4 countries.

Masatoshi Kudo *Department of Gastroenterology and Hepatology, Kindai University Faculty of Medicine, Osaka-Sayama, Japan m-kudo@med.kindai.ac.jp.ORCID 0000-0002-4102-3474
Kazuomi Ueshima *Department of Gastroenterology and Hepatology, Kindai University Faculty of Medicine, Osaka-Sayama, Japan.
Masafumi IkedaDepartment of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital East, Kashiwa, Japan.
Takuji TorimuraDepartment of Gastroenterology and Hepatology, Kurume University School of Medicine, Kurume, Japan.
Nobukazu TanabeDepartment of Gastroenterology, National Hospital Organisation Sendai Medical Center, Sendai, Japan.
Hiroshi AikataDepartment of Gastroenterology and Metabolism, Hiroshima University, Hiroshima, Japan.
Namiki IzumiDepartment of Gastroenterology, Musashino Red Cross Hospital, Tokyo, Japan.
Takahiro YamasakiDepartment of Gastroenterology and Hepatology, Yamaguchi University Graduate School of Medicine, Ube-Yamaguchi, Japan.
Shunsuke NojiriDepartment of Gastroenterology and Metabolism, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan.
Keisuke HinoDepartment of Hepatology and Pancreatology, Kawasaki Medical School, Kurashiki, Japan.
Hidetaka TsumuraDepartment of Gastroenterology and Hepatology, Hyogo Cancer Center, Akashi, Japan.
Teiji KuzuyaDepartment of Gastroenterology and Hepatology, Nagoya University Graduate School of Medicine, Nagoya, Japan.
Norio IsodaDepartment of Medicine, Division of Gastroenterology, Jichi Medical University, Shimotsuke, Japan.
Kohichiroh YasuiDepartment of Gastroenterology and Hepatology, Kyoto Prefectural University of Medicine, Kyoto, Japan.
Hajime AinoDivision of Gastroenterology, Department of Medicine, Social Insurance Tagawa Hospital, Tagawa, Japan.
Akio IdoDepartment of Gastroenterology and Hepatology, Kagoshima University Graduate School of Medical and Dental Sciences, Kagoshima, Japan.
Naoto KawabeDepartment of Liver, Biliary Tract and Pancreas Diseases, Fujita Health University School of Medicine, Aichi, Japan.
Kazuhiko NakaoDepartment of Gastroenterology and Hepatology, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan.
Yoshiyuki WadaDepartment of Hepato-Biliary-Pancreatic Surgery, Clinical Research Institute, National Hospital Organization Kyushu Medical Center, Fukuoka, Japan.
Osamu YokosukaDepartment of Gastroenterology, School of Medicine, Chiba University, Chiba, Japan.
Kenichi YoshimuraCenter for Integrated Medical Research, Hiroshima University, Hiroshima, Japan.
Takuji OkusakaDepartment of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital, Tokyo, Japan.
Junji FuruseDepartment of Medical Oncology, Kyorin University Faculty of Medicine, Mitaka, Japan.
Norihiro KokudoDepartment of Surgery, National Center for Global Health and Medicine, Tokyo, Japan.
Kiwamu OkitaDeapartment of Medicine, Shunan Memorial Hospital, Kudamatsu, Yamaguchi, Japan.
Philip James JohnsonDepartment of Molecular and Clinical Cancer Medicine, University of Liverpool, Liverpool, UK.ORCID 0000-0003-1404-0209
Yasuaki AraiDepartment of Diagnostic Radiology, National Cancer Center Hospital, Tokyo, Japan.
TACTICS study group
Hiroshima University · JPKindai University · JPNational Cancer Center · USChiba University · JPFujita Health University · JPHyogo Prefectural Cancer Center · JPJichi Medical University · JPKagoshima University · JPKawasaki Medical School · JPKurume University · JPKyorin University · JPKyoto Prefectural University of Medicine · JPMusashino Red Cross Hospital · JPNagasaki University · JPNagoya City University · JPNagoya University · JPNational Cancer Center Hospital East · JPNational Center for Global Health and Medicine · JPNational Kyushu Medical Center · JPSendai Medical Center · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveThis trial compared the efficacy and safety of transarterial chemoembolisation (TACE) plus sorafenib with TACE alone using a newly established TACE-specific endpoint and pre-treatment of sorafenib before initial TACE.

designPatients with unresectable hepatocellular carcinoma (HCC) were randomised to TACE plus sorafenib (n=80) or TACE alone (n=76). Patients in the combination group received sorafenib 400 mg once daily for 2-3 weeks before TACE, followed by 800 mg once daily during on-demand conventional TACE sessions until time to untreatable (unTACEable) progression (TTUP), defined as untreatable tumour progression, transient deterioration to Child-Pugh C or appearance of vascular invasion/extrahepatic spread. Co-primary endpoints were progression-free survival (PFS), which is not a conventional one but defined as TTUP, or time to any cause of death plus overall survival (OS). Multiplicity was adjusted by gatekeeping hierarchical testing.

resultsMedian PFS was significantly longer in the TACE plus sorafenib than in the TACE alone group (25.2 vs 13.5 months; p=0.006). OS was not analysed because only 73.6% of OS events were reached. Median TTUP (26.7 vs 20.6 months; p=0.02) was also significantly longer in the TACE plus sorafenib group. OS at 1 year and 2 years in TACE plus sorafenib group and TACE alone group were 96.2% and 82.7% and 77.2% and 64.6%, respectively. There were no unexpected toxicities.

conclusionTACE plus sorafenib significantly improved PFS over TACE alone in patients with unresectable HCC. Adverse events were consistent with those of previous TACE combination trials. TRIAL REGISTRATION NUMBER: NCT01217034.

Indexed as

Chemoembolization, TherapeuticAdultAgedAged, 80 and overAntineoplastic AgentsCarcinoma, HepatocellularCombined Modality TherapyDisease ProgressionFemaleHumansLiver NeoplasmsMaleMiddle AgedProgression-Free SurvivalProspective StudiesSorafenibAntineoplastic AgentsSorafenibcombination therapy with transarterial chemoembolisation and sorafenibhepatocellular carcinomaprogression-free survivalsorafenibtransarterial chemoembolization

Identifiers

PMID31801872
PMCPMC7398460
OpenAlexW2996066981

What OpenQuestion holds

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LicenceCC BY-NC
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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.