Pancreatic Cancer
Conditions
Keywords
Pancreatic Cancer, S1, DC-CIK
Brief summary
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.
Interventions
BIOLOGICALDC-CIK Treatment
The DC-CIK cells were infused on days 15, 17, and 19 of 21-day cycles.
DRUGS1
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.
OTHERBest supportive care
Best supportive care
Sponsors
Capital Medical University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologically or cytologically confirmed locally advanced, unresectable or metastatic adenocarcinoma of the pancreas not amenable to curative radiotherapy or surgery. * Capable of oral intake * Between 18 and 80 years old * Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria * Karnofsky Performance Status (KPS) ≥ 70% * Normal functions of heart, lung and bone marrow * Adequate hematological profile： Hemoglobin ≥ 9.0 g/dL Absolute granulocyte count ≥ 1,500/mm3 Platelet count ≥ 100,000/mm3 * Adequate hepatic function Total bilirubin level≤ 3.0 times the upper limit of normal (ULN) Transaminases AST (SGOT) and ALT (SGPT) ≤ 2.5 times ULN * Adequate renal function(normal serum creatinine level) * A life expectancy≥ 2 months * Informed consent signed
Exclusion criteria
* Current enrollment in another clinical study with an investigational agent. Patients participating in surveys or observational studies are eligible to participate in this study * Any radiotherapy or surgery within the previous 3 weeks * Symptomatic brain metastasis not controlled by corticosteroids * Bone marrow metastasis * Active infection * Serious complications * Receiving a concomitant treatment with drugs interacting with S-1. The following drugs are prohibited because there may be an interaction with S-1: phenytoin, potassium warfarin , flucytosine, cimetidine and folinic acid. * Pregnant or lactation women, or women with known or suspected pregnancy and men who want let to pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment toxicity | 4 years | Number of participants with treatment-related adverse events as assessed by CTCAE v3.0 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The disease control rate | 4 years | the proportion of patients who had a best response rating of complete response, partial response, or stable disease. |
| Progression free survival（PFS） | 4 years | 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. |
| Overal survival(OS) | 4 years | From starting date of enrollment to this study until date of death from any cause |
| Changing trend of tumor biomarkers | 4 years | The changing of CEA and CA-199 levels among different groups before the treatment and at the end of the first cycle of therapy |
| Phenotypic analysis of peripheral blood immune cells | 4 years | Phenotypic analysis of peripheral blood mononuclear cells before the treatment and at the end of the first cycle of therapy |
Countries
China
Outcome results
None listed