Evidence map›Paper›PMID 20689572›Full record

ArticleCancer gene therapy2010

A phase I clinical trial of thymidine kinase-based gene therapy in advanced hepatocellular carcinoma.

B Sangro, G Mazzolini, M Ruiz, J Ruiz, J Quiroga, I Herrero, C Qian, A Benito, J Larrache, C Olagüe and 4 more

Registry-linked trialAbstract readClinical Trial, Phase I
PubMed Publisher
In one paragraph

Article in Cancer gene therapy, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00844623 (Phase I Clinical Trial Of Gene Therapy For Hepatocellular Carcinoma By Intratumoral Injection Of TK99UN), which is not on this map. Cited by 67 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
67citing papers in PubMed, 1 pooled it
–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.

NCT00844623 phase1completednot on this map

Phase I Clinical Trial Of Gene Therapy For Hepatocellular Carcinoma By Intratumoral Injection Of TK99UN (An Adenoviral Vector Containing The Thymidine Kinase Of Herpes Simplex Virus)

TypeinterventionalSponsorClinica Universidad de Navarra, Universidad de NavarraRan2002 to 2008Enrolled10ConditionsCarcinoma, HepatocellularArmsTK99UN
3 · Its place in the literature

Who cites it

67 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Gene therapy for people with hepatocellular carcinoma.The Cochrane database of systematic reviews · 2024
    Pooled it
  2. Review
  3. Review
  4. Article
  5. Recent developments in translational imaging of in vivo gene therapy outcomes.Molecular therapy : the journal of the American Society of Gene Therapy · 2025
    Review
  6. Article
  7. Article
  8. Article
  9. Review
  10. Article
  11. Article
  12. Review
  13. Review
  14. Review
  15. Article
  16. Article
  17. Review
  18. Article
  19. Article
  20. Recent Advances in Gene Therapy for Cancer Theranostics.Current opinion in biomedical engineering · 2021
    Article

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

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

14 authors.

B SangroLiver Unit, Clínica Universitaria, Pamplona, Spain. bsangro@unav.es
G Mazzolini
M Ruiz
J Ruiz
J Quiroga
I Herrero
C Qian
A Benito
J Larrache
C Olagüe
J Boan
I Peñuelas
B Sádaba
J Prieto

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The aim of this phase I clinical trial was to assess the feasibility and safety of intratumoral administration of a first-generation adenoviral vector encoding herpes simplex virus thymidine kinase (HSV-TK) gene (Ad.TK) followed by systemic ganciclovir to patients with advanced hepatocellular carcinoma (HCC). Secondarily, we have analyzed its antitumor effect. Ten patients were enrolled in five dose-level cohorts that received from 10¹⁰ to 2 × 10¹² viral particles (vp). Ad.TK was injected intratumorally and patients received up to three doses at 30-day intervals. Positron emission tomography was used to monitor TK gene expression. Ad.TK injection was feasible in 100% of cases. Treatment was well tolerated and dose-limiting toxicity was not achieved. Cumulative toxicity was not observed. Hepatic toxicity was absent even in cirrhotic patients. Fever, flu-like syndrome, pain at the injection site and pancytopenia were the most common side effects. No partial responses were observed and 60% of patients showed tumor stabilization of the injected lesion. Importantly, two patients who received the highest dose showed signs of intratumoral necrosis by imaging procedures. One of them achieved a sustained stabilization and survived for 26 months. In conclusion, Ad.TK can be safely administered by intratumoral injection to patients with HCC up to 2 × 10¹² vp per patient.

Indexed as

Genetic TherapyAdolescentAdultAgedAged, 80 and overCarcinoma, HepatocellularFemaleGanciclovirGenetic VectorsHumansLiver NeoplasmsMaleMiddle AgedPositron-Emission TomographyThymidine KinaseGanciclovirThymidine Kinase

Identifiers

PMID20689572

What OpenQuestion holds

Textmetadata
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.