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

Capital Medical University47 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Pancreatic Cancer

Interventions

DC-CIK TreatmentBIOLOGICAL

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

S1DRUG

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.

Best supportive careOTHER

Best supportive care

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Capital Medical University Cancer Center

Beijing, Beijing Municipality, China

Outcomes

Primary Outcomes

Treatment toxicity

Number of participants with treatment-related adverse events as assessed by CTCAE v3.0

Time frame: 4 years

Secondary Outcomes

The disease control rate

the proportion of patients who had a best response rating of complete response, partial response, or stable disease.

Time frame: 4 years

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.

Time frame: 4 years

Overal survival(OS)

From starting date of enrollment to this study until date of death from any cause

Time frame: 4 years

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

Time frame: 4 years

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

Time frame: 4 years

Data from ClinicalTrials.gov

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