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NCT05051696
Intra-tumor Injection of Oncolytic Viruses H101 Combined With or Without Radiotherapy in Refractory/Recurrent Gynecological Malignancies
Phase 2 trial testing H101 in Genital Neoplasms, Female in 120 participants. Participants enrolled and being followed up; not accepting new ones.
30 March 2024
Quick facts
| Lead sponsor | Liu Zi |
|---|---|
| Phase | Phase 2 |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 120 |
| Start date | 26 September 2021 |
| Primary completion | 30 March 2024 |
| Estimated completion | 30 March 2025 |
| Sites | 1 location across China |
Drugs / interventions tested
- H101 — full drug profile →
Conditions studied
- Genital Neoplasms, Female — all drugs for Genital Neoplasms, Female →
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):
-
Biomaterial-Based In Situ Cancer Vaccines.
Bo Y, Wang H. · · 2024 · cited 55× · PMID 36649567 · DOI 10.1002/adma.202210452 -
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 -
Advances in the clinical development of oncolytic viruses.
Li K, Zhao Y, Hu X, Jiao J, et al · · 2022 · cited 33× · PMID 35836877 -
A Renaissance for Oncolytic Adenoviruses?
Blanchette P, Teodoro JG. · · 2023 · cited 18× · PMID 36851572 · DOI 10.3390/v15020358 -
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 -
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 -
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 -
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
Verify or expand the search:
- PubMed search for NCT05051696
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of H101
Trials testing the same drug.
- NCT06196671 — Oncolytic Virus Plus PD-1 Inhibitor to Patients With Advanced Pancreatic Cancer · Phase 2 · not yet recruiting
- NCT07398664 — H101 Plus TACE for r/m HNSCC · Phase 2 · not yet recruiting
- NCT07381309 — Oncolytic Virus (H101) + SBRT + Chemotherapy + Targeted Therapy + Immunotherapy for Unresectable CRLM · Phase 2 · not yet recruiting
- NCT06919848 — Oncolytic Virus H101 Combined With Lenvatinib Plus Toripalimab Compared With FOLFOX in Patients With Advanced Biliary Tr · Phase 2 · not yet recruiting
- NCT05823987 — Oncolytic Virotherapy Combined With Tislelizumab Plus Lenvatinib in Patients With Advanced Biliary Tract Cancer (OPTIONS · Phase 2 · unknown
Other recruiting trials for Genital Neoplasms, Female
Currently open trials in the same condition.
- NCT07038369 — A Phase 1 Study of ATV-1601 in Patients With Advanced Cancer That Have AKT1 E17K Mutations · Phase 1 · active not recruiting
- NCT04807166 — Anlotinib Combined With Carboplatin/Paclitaxel as First-line Treatment in Patients With Advanced Ovarian Cancer · Phase 2 · active not recruiting
- NCT06741046 — RT for Cervical Adenocarcinoma/adenosquamous Carcinoma · active not recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05051696 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Liu Zi
- Last refreshed: 4 June 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05051696.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing