Clinical trial · Interventional
A Phase I Study of Recombinant hGM-CSF Herpes Simplex Virus to Treat Cancer
A Phase I Study of Recombinant hGM-CSF Herpes Simplex Virus
NCT01935453CI-TRIAL-00023747completedPhase 1ClinicalTrials.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 main purpose of this study is to study the safety of OrienX010 in the treatment of kinds of solid tumors such as melanoma,liver cancer,pancreatic cancer and lung cancer.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Liver Cancer | Malignant Liver Neoplasm | CURATED_EXACT | 0.92 |
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
| Melanoma | Melanoma | ONTOLOGY_EXACT | 0.98 |
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Recombinant hGM-CSF Herpes Simplex Virus Injection | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Recombinant HSV-1 Injection
- description
- Intratumoral injection Single dose: 4 groups -- 106 pfu, 107 pfu, 108 pfu and 4×108 pfu Multiple dose (three injections, every 2 weeks): 2 groups -- 108, 108, 108pfu and 4×108, 4×108, 4×108pfu Continuous treatment: Upon 4 weeks follow-up after administration, if the investigator deems that continuous treatment will benefit subjects, continuous intratumoral injection may be given, and the interval between each injection will be 2 weeks.
- interventionNames
- Biological: Recombinant hGM-CSF Herpes Simplex Virus Injection
Primary outcomes (1)
- measure
- Exploring the MTD of OrienX010 according to DLT,which defined as the serious degree of adverse events relates to the medicine not less than grade 3 of CTCAE v4.03
- timeFrame
- 28 days after the last administration
Secondary outcomes (1)
- measure
- Using RECIST 1.1 to evaluate the preliminary efficacy of OrienX010
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * patients in advanced stage of malignant tumor diagnosticated by pathologic and cytological analysis. * lack of routine effective treatment,failure of routine treatment or relapse * age of 18-70,ECOG 0-2 and estimated survival is above 3 months * had an interval of above 4 weeks since exposure to chemotherapy or radiotherapy and above 6 weeks since exposure to nitrosoureas or mitomycin C. Exclusion Criteria: * Serious internal diseases * uncontrolled primary and metastatic brain tumor * sizes of tumor does not meet the requirement of injection
References
Publications (0)
Data not yet available
No reference posted for this study.