Evidence map›Paper›PMID 34041204›Full record

Trial reportJournal of hepatocellular carcinoma2021

Phase I Trial on Arterial Embolization with Hypoxia Activated Tirapazamine for Unresectable Hepatocellular Carcinoma.

Nadine Abi-Jaoudeh, Farshid Dayyani, Pei Jer Chen, Dayantha Fernando, Nicholas Fidelman, Hanna Javan, Po-Chin Liang, Jen-I Hwang, David K Imagawa

2 registry-linked trialsOpen access · goldAbstract readCase ReportsClinical Trial
In one paragraph

Trial report in Journal of hepatocellular carcinoma, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 20 papers.

0numbers the graph read from it
0cells of the map it votes in
20citing papers in PubMed
2.7field-weighted citation impact, top 8% 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.

NCT02174549 phase1 / phase2recruitingnot on this map

Phase I Dose-Escalating Study of Combining Intravenous Tirapazamine and Transarterial Embolization (TAE) in Liver Cancer

TypeinterventionalSponsorTeclison Ltd.Ran2014 to 2028Enrolled25ConditionsHepatocellular Carcinoma, Gastrointestinal Cancer Metastatic, Neuroendocrine TumorsArmsTirapazamine, Conventional Transarterial Embolization (TAE)
NCT03259867 phase2recruitingnot on this map

Phase IIA Single-Arm Study of Treatment of Patients With Advanced Liver Cancer With a Combination of TATE (Transarterial Tirapazamine Embolization) Followed by an Anti-PD-1 Monoclonal Antibody

TypeinterventionalSponsorTeclison Ltd.Ran2017 to 2027Enrolled54ConditionsHepatocellular Carcinoma, Gastric CancerArmsNivolumab Injectable Product, Trans-arterial tirapazamine embolization
3 · Its place in the literature

Who cites it

20 citing papers in PubMed, 28 citations in OpenAlex.

  1. Trial
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  14. Article
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  16. Article
  17. Targeting hypoxia in solid and haematological malignancies.Journal of experimental & clinical cancer research : CR · 2022
    Review
  18. Interventional oncology: new techniques and new devices.The British journal of radiology · 2022
    Review
  19. Article
  20. Review
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

9 authors at 4 institutions in 2 countries.

Nadine Abi-JaoudehDepartment of Radiological Sciences, University of California Irvine, Orange, CA, USA.ORCID 0000-0001-6163-8524
Farshid DayyaniChao Comprehensive Digestive Disease, University of California Irvine, Orange, CA, USA.ORCID 0000-0002-4970-5189
Pei Jer ChenHepatitis Research Center, National Taiwan University, Taipei City, Taiwan.
Dayantha FernandoDepartment of Radiological Sciences, University of California Irvine, Orange, CA, USA.ORCID 0000-0001-5649-1433
Nicholas FidelmanDepartment of Radiology, University of California San Francisco, San Francisco, CA, USA.ORCID 0000-0002-6040-4184
Hanna JavanDepartment of Radiological Sciences, University of California Irvine, Orange, CA, USA.
Po-Chin LiangDepartment of Medical Imaging, National Taiwan University, Taipei City, Taiwan.
Jen-I HwangDepartment of Radiology, Taichung Veteran General Hospital, Taichung, Taiwan.
David K ImagawaSurgery Services, University of California Irvine, Orange, CA, USA.ORCID 0000-0002-4970-5189
University of California, Irvine · USNational Taiwan University · TWTaichung Veterans General Hospital · TWUniversity of California, San Francisco · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundTirapazamine (TPZ) is a hypoxia activated drug that may be synergistic with transarterial embolization (TAE). The primary objective was to evaluate the safety of combining TPZ and TAE in patients with unresectable HCC and determine the optimal dose for Phase II.

methodsThis was a Phase 1 multicenter, open-label, non-randomized trial with a classic 3+3 dose escalation and an expansion cohort in patients with unresectable HCC, Child Pugh A, ECOG 0 or 1. Two initial cohorts consisted of I.V. administration of Tirapazamine followed by superselective TAE while the remaining three cohorts underwent intraarterial administration of Tirapazamine with superselective TAE. Safety and tolerability were assessed using NCI CTCAE 4.0 with clinical, imaging and laboratory examinations including pharmacokinetic (PK) analysis and an electrocardiogram 1 day pre-dose, at 1, 2, 4, 6, 10, and 24 hours post-TPZ infusion and an additional PK at 15- and 30-minutes post-TPZ. Tumor responses were evaluated using mRECIST criteria.

resultsTwenty-seven patients (mean [range] age of 66.4 [37-79] years) with unresectable HCC were enrolled between July 2015 and January 2018. Two patients were lost to follow-up. Mean tumor size was 6.53 cm ± 2.60 cm with a median of two lesions per patient. Dose limiting toxicity and maximum tolerated dose were not reached. The maximal TPZ dose was 10 mg/m DISCUSSION: TAE with TPZ was safe and tolerable with encouraging results justifying pursuit of a Phase II trial.

Indexed as

hepatocellular carcinomahypoxia activated agentimage guided locoregional therapiesphase I trialtransarterial chemoembolization

Identifiers

PMID34041204
PMCPMC8139681
OpenAlexW3163810927

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

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.