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

Pancreatic Cancer Clinical Trial

Official title:

Dendritic Cell/Cytokine-Induced Killer Cell Immunotherapy Combined With S-1 in Patients With Advanced Pancreatic Cancer: A Prospective Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01781520
• Other study ID #: S1+DC CIK-P
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: January 30, 2013
• Last updated: January 16, 2018
• Start date: June 1, 2013
• Est. completion date: June 13, 2017

Study information

• Verified date: January 2018
• Source: Capital Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: June 13, 2017
• Est. primary completion date: May 30, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Biological:
• DC-CIK Treatment
The DC-CIK cells were infused on days 15, 17, and 19 of 21-day cycles.

Drug:
• S1
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.

Other:
• Best supportive care
Best supportive care

Locations

Country	Name	City	State
China	Capital Medical University Cancer Center	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Capital Medical University

Country where clinical trial is conducted

China, 

References & Publications (1)

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 Pa — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment toxicity	Number of participants with treatment-related adverse events as assessed by CTCAE v3.0	4 years
Secondary	The disease control rate	the proportion of patients who had a best response rating of complete response, partial response, or stable disease.	4 years
Secondary	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.	4 years
Secondary	Overal survival(OS)	From starting date of enrollment to this study until date of death from any cause	4 years
Secondary	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
Secondary	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

External Links

•   Published article for this study