Study of S-1 Plus DC-CIK for Patients With Unresectable Locally Advanced Pancreatic Cancer
This study is currently recruiting participants.
Verified January 2013 by Capital Medical University
Sponsor:
Capital Medical University
Information provided by (Responsible Party):
Jun Ren MD, PhD, Capital Medical University
ClinicalTrials.gov Identifier:
NCT01781520
First received: January 30, 2013
Last updated: February 1, 2013
Last verified: January 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Pancreatic Cancer |
Other: S-1 plus DC-CIK |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
Resource links provided by NLM:
Further study details as provided by Capital Medical University:
Primary Outcome Measures:
- Progression free survival（PFS） [ Time Frame: 4 years ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Two year survival rate [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Adverse events [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
- Response rate [ Time Frame: 4 years ] [ Designated as safety issue: No ]
- Quality of life [ Time Frame: 1 year ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 30 |
| Study Start Date: | January 2013 |
| Estimated Study Completion Date: | December 2017 |
| Estimated Primary Completion Date: | December 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: S-1 plus DC-CIK
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 3 days before administrating S-1 , and cultured DC-CIK cells for 10 days. Cells were infused back to the patients in 3 times. |
Other: S-1 plus DC-CIK |
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01781520
Contacts
| Contact: Jun Ren, MD, PhD | 86-10-63926317 | renjun9688@yahoo.com |
Locations
| China, Beijing | |
| Capital Medical University Cancer Center | Recruiting |
| Beijing, Beijing, China, 100038 | |
| Contact: Jun Ren, MD, PhD 86-10-63926317 renjun9688@yahoo.com | |
| Principal Investigator: Jun Ren, MD,PhD | |
Sponsors and Collaborators
Capital Medical University
More Information
No publications provided
| Responsible Party: | Jun Ren MD, PhD, Director,Capital Medical University (CMU)Cancer Center, Capital Medical University |
| ClinicalTrials.gov Identifier: | NCT01781520 History of Changes |
| Other Study ID Numbers: | S1+DC CIK-P |
| Study First Received: | January 30, 2013 |
| Last Updated: | February 1, 2013 |
| Health Authority: | China: Ethics Committee |
Keywords provided by Capital Medical University:
|
Pancreatic Cancer S1 DC-CIK |
Additional relevant MeSH terms:
|
Pancreatic Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms |
Endocrine Gland Neoplasms Digestive System Diseases Pancreatic Diseases Endocrine System Diseases |
ClinicalTrials.gov processed this record on May 16, 2013