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The purpose of this study is to evaluate the antitumor effect and safety of clinical effectiveness S-1 plus dendritic cell activated Cytokine induced killer treatment (DC-CIK) for unresectable locally advanced pancreatic cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| S-1 plus DC-CIK | Experimental | Chemotherapy: S-1 is administered orally twice daily at a dose of 80,100, or 120mg/day for body surface areas of less than 1.25m2, between 1.25m2 and less than 1.5, or 1.5m2 or greater, respectively, for 14 consecutive days, followed by a 7-day rest, repeated every 3 weeks. DC-CIK Immunotherapy:Mononuclear cells were collected aseptically with blood cell separator composition aphaeresis, and then cultured DC-CIK cells were infused back to the patients on days 15, 17, and 19 of 21-day cycles. |
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| DC-CIK alone | Active Comparator | DC-CIK Immunotherapy:Mononuclear cells were collected aseptically with blood cell separator composition aphaeresis, and then cultured DC-CIK cells were infused back to the patients on days 15, 17, and 19 of 21-day cycles. |
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| S-1 alone | Active Comparator | Chemotherapy: S-1 is administered orally twice daily at a dose of 80,100, or 120mg/day for body surface areas of less than 1.25m2, between 1.25m2 and less than 1.5, or 1.5m2 or greater, respectively, for 14 consecutive days, followed by a 7-day rest, repeated every 3 weeks. |
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| Best supportive care | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DC-CIK Treatment | Biological | The DC-CIK cells were infused on days 15, 17, and 19 of 21-day cycles. |
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| Measure | Description | Time Frame |
|---|---|---|
| Treatment toxicity | Number of participants with treatment-related adverse events as assessed by CTCAE v3.0 | 4 years |
| Measure | Description | Time Frame |
|---|---|---|
| The disease control rate | the proportion of patients who had a best response rating of complete response, partial response, or stable disease. | 4 years |
| Progression free survival(PFS) | From starting date of enrollment to this study until date of first documented disease progression or date of death from any cause, whichever comes first. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Capital Medical University Cancer Center | Beijing | Beijing Municipality | 100038 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28611200 | Result | Jiang N, Qiao G, Wang X, Morse MA, Gwin WR, Zhou L, Song Y, Zhao Y, Chen F, Zhou X, Huang L, Hobeika A, Yi X, Xia X, Guan Y, Song J, Ren J, Lyerly HK. Dendritic Cell/Cytokine-Induced Killer Cell Immunotherapy Combined with S-1 in Patients with Advanced Pancreatic Cancer: A Prospective Study. Clin Cancer Res. 2017 Sep 1;23(17):5066-5073. doi: 10.1158/1078-0432.CCR-17-0492. Epub 2017 Jun 13. |
| Label | URL |
|---|---|
| Published article for this study | View source |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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| ID | Term |
|---|---|
| C079198 | S 1 (combination) |
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| S1 | Drug | The dose of S-1 is determined according to the body surface area as follows: <1.25 m2, 40 mg; 1.25-<1.5 m2, 50 mg; and >1.5 m2, 60 mg, given twice daily after meals for 14 days followed by a 7-day rest. Cycles is repeated every 21 days. Treatment is continued until disease progression, unacceptable toxic effects, or the withdrawal of consent. |
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| Best supportive care | Other | Best supportive care |
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| 4 years |
| Overal survival(OS) | From starting date of enrollment to this study until date of death from any cause | 4 years |
| Changing trend of tumor biomarkers | The changing of CEA and CA-199 levels among different groups before the treatment and at the end of the first cycle of therapy | 4 years |
| Phenotypic analysis of peripheral blood immune cells | Phenotypic analysis of peripheral blood mononuclear cells before the treatment and at the end of the first cycle of therapy | 4 years |
| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |