Liver Cancer, Lung Cancer, Melanoma, Pancreatic Cancer
Conditions
Brief summary
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.
Interventions
BIOLOGICALRecombinant hGM-CSF Herpes Simplex Virus Injection
Sponsors
START Shanghai
Beijing Bozhiyin T&S Co., Ltd.
OrienGene Biotechnology Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | 28 days after the last administration |
Secondary
| Measure | Time frame |
|---|---|
| Using RECIST 1.1 to evaluate the preliminary efficacy of OrienX010 | 28 days after the last administration |
Countries
China
Outcome results
None listed