Study of S-1 Plus DC-CIK for Patients With Unresectable Locally Advanced Pancreatic Cancer

Phase 1

Completed

• Conditions: Pancreatic Cancer
• Interventions: Biological: DC-CIK Treatment; Other: Best supportive care; Drug: S1

• 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

Study Timeline

• Study First Submitted: 2013-01-30
• Study First Submitted QC: 2013-01-30
• Study First Posted: 2013-02-01
• Study Start: 2013-06-01
• Primary Completion: 2016-05-30
• Study Completion: 2017-06-13
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-16
• Last Update Posted: 2018-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 47

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

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