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Completed

NCT Number: NCT01781520

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

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.

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Key information

Conditions

Pancreatic Cancer Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Neoplasms Neoplasms by Site Pancreatic Diseases Pancreatic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Capital Medical University Cancer Center

Beijing, Beijing Municipality, 100038, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DC-CIK Treatment

Biological

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

S1

Drug

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 care

Other

Best supportive care

Primary outcomes

  1. Treatment toxicity

    Time frame: 4 years

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

Secondary outcomes

  1. The disease control rate

    Time frame: 4 years

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

  2. Progression free survival（PFS）

    Time frame: 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.

  3. Overal survival(OS)

    Time frame: 4 years

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

  4. Changing trend of tumor biomarkers

    Time frame: 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

  5. Phenotypic analysis of peripheral blood immune cells

    Time frame: 4 years

    Phenotypic analysis of peripheral blood mononuclear cells before the treatment and at the end of the first cycle of therapy

Sponsors and collaborators

Lead sponsor

Capital Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2016
Study completion
2017
First posted
Feb 1, 2013
Registry last updated
Jan 18, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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