Overview

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

Status:
Completed
Trial end date:
2017-06-13
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 1/Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Capital Medical University
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