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NCT05051696

Intra-tumor Injection of Oncolytic Viruses H101 Combined With or Without Radiotherapy in Refractory/Recurrent Gynecological Malignancies

Active, enrolled Phase 2 Last updated 4 June 2024
What this trial tests

Phase 2 trial testing H101 in Genital Neoplasms, Female in 120 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline
26 September 2021
Primary endpoint
30 March 2024
30 March 2025

Quick facts

Lead sponsorLiu Zi
PhasePhase 2
StatusActive, enrolled
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment120
Start date26 September 2021
Primary completion30 March 2024
Estimated completion30 March 2025
Sites1 location across China

Drugs / interventions tested

Conditions studied

Sponsor

Liu Zi

Who can join

18 and older, female only, with Genital Neoplasms, Female. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The purpose of this clinical trial is to evaluate the effectiveness and safety of oncolytic viruses H101 intra-tumor injection combined with or without radiotherapy in refractory or recurrent gynecological malignancies. And further research the mechanism of oncolytic viruses H101.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Biomaterial-Based In Situ Cancer Vaccines.
    Bo Y, Wang H. · · 2024 · cited 55× · PMID 36649567 · DOI 10.1002/adma.202210452
  2. Tumor microbiome metabolism: A game changer in cancer development and therapy.
    Zhou X, Kandalai S, Hossain F, Zheng Q. · · 2022 · cited 33× · PMID 35936744 · DOI 10.3389/fonc.2022.933407
  3. Advances in the clinical development of oncolytic viruses.
    Li K, Zhao Y, Hu X, Jiao J, et al · · 2022 · cited 33× · PMID 35836877
  4. A Renaissance for Oncolytic Adenoviruses?
    Blanchette P, Teodoro JG. · · 2023 · cited 18× · PMID 36851572 · DOI 10.3390/v15020358
  5. Targeted therapy and immunotherapy: Diamonds in the rough in the treatment of epithelial ovarian cancer.
    Huang X, Li XY, Shan WL, Chen Y, et al · · 2023 · cited 14× · PMID 37033645 · DOI 10.3389/fphar.2023.1131342
  6. Efficacy and Safety of Recombinant Human Adenovirus Type 5 (H101) in Persistent, Recurrent, or Metastatic Gynecologic Malignancies: A Retrospective Study.
    Zhang J, Zhang Q, Liu Z, Wang J, et al · · 2022 · cited 14× · PMID 35574359 · DOI 10.3389/fonc.2022.877155
  7. Therapeutic Implementation of Oncolytic Viruses for Cancer Immunotherapy: Review of Challenges and Current Clinical Trials.
    Wang X, Maeng HM, Lee J, Xie C. · · 2022 · cited 5× · PMID 36381110 · DOI 10.36266/jbsr/164
  8. Recombinant Human Adenovirus Type 5 (H101) Intra-Tumor Therapy in Patients with Persistent, Recurrent, or Metastatic Cervical Cancer: Genomic Profiling Relating to Clinical Efficacy.
    Zhang Q, Zhang J, Liu Z, Wang J, et al · · 2023 · cited 4× · PMID 38046281 · DOI 10.2147/dddt.s429180

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Other trials of H101

Trials testing the same drug.

Other recruiting trials for Genital Neoplasms, Female

Currently open trials in the same condition.

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Data sources for this page

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