Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to investigate the effect of very low dose decitabine combinate with gemcitabine in the first-line treatment of locally advanced, unresectable and metastatic pancreatic cancer.
This study intends to advanced pancreatic cancer with row standard with district group random way is divided into two groups, a group for the gemcitabine monotherapy in the treatment group, another group of gemcitabine combined with low dose of decitabine treatment group. The overall survival, progression free survival, and disease control rate were observed in patients treated with combined therapy. At the same time, its safety and tolerance were observed. The methylation status and its influence on the immune function were also detected by biological test.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| decitabine & gemcitabine | Experimental | This group was treated by low dose decitabine combinated with gemcitabine regimen. decitabine: 5mg/m2 d1-d5; gemcitabine: 1.0g/m2,d8,d15,d22. 28days for one cycle. every 28days for one cycle |
|
| gemcitabine | Active Comparator | This group was treated by gemcitabine only. Gemcitabine: 1.0g/m2, d8,d15,d22; 28 days for one cycle. every 28days for one cycle |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Decitabine | Drug | decitabine 5mg/m2,d1-d5; |
| |
| Measure | Description | Time Frame |
|---|---|---|
| overall survival | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Evidence of the size of the lesion in pancreas confirmed by non-investigational CT or MRI | within every 28 days(plus or minus 3 days) ,up to 36 days. From date of randomization until the date of death from any cause, assessed up to 50 months. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077209 | Decitabine |
| D000093542 | Gemcitabine |
| ID | Term |
|---|---|
| D001374 | Azacitidine |
| D001372 | Aza Compounds |
| D009930 | Organic Chemicals |
| D003562 | Cytidine |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Gemcitabine |
| Drug |
gemcitabine 1.0g/m2, d8,d15,d22 |
|
| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D011741 |
| Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012263 | Ribonucleosides |
| D003841 | Deoxycytidine |