Study of S-1 Plus DC-CIK for Patients With Unresectable Locally Advanced Pancreatic Cancer
- Conditions
- Pancreatic Cancer
- Interventions
- Registration Number
- NCT01781520
- Lead Sponsor
- Capital Medical University
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 47
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description S-1 plus DC-CIK DC-CIK Treatment 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. DC-CIK alone DC-CIK Treatment 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. Best supportive care Best supportive care - S-1 plus DC-CIK S1 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. S-1 alone S1 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.
- Primary Outcome Measures
Name Time Method Treatment toxicity 4 years Number of participants with treatment-related adverse events as assessed by CTCAE v3.0
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Capital Medical University Cancer Center
🇨🇳Beijing, Beijing, China