Clinical trial · Interventional
Intra-tumor Injection of Oncolytic Viruses H101 Combined With or Without Radiotherapy in Refractory/Recurrent Gynecological Malignancies
NCT05051696CI-TRIAL-00077715unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Genital Neoplasms, Female | Female Reproductive System Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| H101 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Oncorine (H101) with or without radiotherapy
- description
- The tumor mass was injected with H101 per day for 5 consecutive days, 3 weeks as one treatment cycle, and 1 to 4 cycles according to the condition of the patient, and the patient was treated with or without radiotherapy in sequential. The injection dose of H101 was determined by the tumor volume or maximum tumor diameter:5.0×10\^11 virus particles(VP) for if tumor diameter≤5cm; 1×10\^12 VP for the tumor diameter between 5cm and 10cm, and 1.5×10\^12 VP for the tumor diameter\>10cm.
- interventionNames
- Drug: H101
Primary outcomes (1)
- measure
- Local Control (LC)
- timeFrame
- 3 months
- description
- LC will be measured from the start date of injection until the date of progressive disease
Secondary outcomes (3)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Written informed consent obtained. * Age ≥ 18 years at the time of study entry. * Histological or Cytologically diagnosed gynecological malignancies. * Failure to prior standard treatment (surgery, chemotherapy, radiotherapy); * Refractory/recurrence/metastasis gynecological cancer * At least one measurable lesion according to the RECIST1.1. * Cooperative Oncology Group-Status (ECOG Status) 0-3. * The last treatment should be over 2 weeks. Exclusion Criteria: * History or evidence of active autoimmune disease that requires systemic treatment. * Participated in other anti-tumor clinical trials within 4 weeks. * Patients who have a contraindication to similar drugs. * That failure to follow up regularly.
References
Publications (0)
Data not yet available
No reference posted for this study.