Autologous Cytokine-induced Killer Cells Combined Chemotherapy in Advanced Pancreatic Cancer

Autologous Cytokine-induced Killer Cells Combined Chemotherapy in Advanced Pancreatic Cancer: A Prospective, Randomized, Open, Single Center Phase II Study

The purpose of this study is to determine whether Cytokine induced killer cells combined chemotherapy is more effective in the treatment of advanced Pancreatic Cancer.

Study Overview

• Status: Terminated
• Conditions: Advanced Cancer
• Intervention / Treatment: Biological: Cytokine-induced Killer Cells; Drug: Tegafur-Gimeracil-Oteracil Potassium

Detailed Description

Pancreatic cancer is a devastating malignant disease with a median survival of 3-6 months and a 5-year survival rate of less than 5%. It is necessary to explore more treatment mode to pancreatic cancer especially advanced stage patients. This study is a prospective, randomized, open, single center phase II study. The investigators try to evaluate the efficacy and safety of this treatment mode.

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Henan
    • Zhengzhou, Henan, China, 450008
      • Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. No less than 18 years old
2. Karnofsky Performance Status over 60
3. Life expectancy more than three months
4. Pathological diagnosed as pancreatic epithelial cell carcinoma
5. Recurrence after surgery or unresectable
6. No experienced chemotherapy or the interval between the last adjuvant chemotherapy and relapse is at least 6 months
7. Measurable lesions (by CT or MRI)
8. No serious mental disorders
9. Adequate organ and bone marrow functions
10. No other serious and the conflict diseases(such as autoimmune diseases, immunodeficiency, organ transplantation)
11. No other malignant tumor history
12. Informed consent and willing to participate in this study

Exclusion Criteria:

1. Received immunosuppressants or glucocorticoid treatment
2. Uncontrolled severe infection or unhealed wound caused by suppurative inflammation
3. Heart disease, insufficient heart function, II degree heart block or occurred myocardial infarction in 6 months
4. Poor pulmonary functions caused by interstitial lung disease and pulmonary reserve volume under 80% of the expected value
5. Other malignant tumor history
6. Transaminase>2.5ULN or bilirubin>3ULN or creatinine >1.25ULN
7. Pregnant or lactating women
8. Obvious bleeding tendency
9. Participated other clinical trails in 1 month
10. Other unsuitable conditions: HIV infection, intravenous drug abusers, etc

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: CIK combined chemotherapy; Autologous Cytokine induced killer cells combined Tegafur, Gimeracil and Oteracil Potassium Capsules. After 2 to 4 days of chemotherapy, about 5×10９autologous cytokine induced killer cells are transfused into the vein of the patients in one hour.	Biological: Cytokine-induced Killer Cells; Drug: Tegafur-Gimeracil-Oteracil Potassium
ACTIVE_COMPARATOR: Chemotherapy; Tegafur,Gimeracil and Oteracil Potassium Capsules 40-60mg, bid, po, D1-14, Q3w	Drug: Tegafur-Gimeracil-Oteracil Potassium

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Overall Survival	From the date of randomization to the date of death from any cause up to 36 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Progression Free Survival	From the date of randomization to the date of first documented progression up to 24 months
Quality of life assessed by Questionnaire	one year by questionnaire

Collaborators and Investigators

• Sponsor: Henan Cancer Hospital
• Investigators: Principal Investigator: Quanli Gao, Ph.D., Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital

Publications and helpful links

General Publications

• Imaoka H, Kou T, Tanaka M, Egawa S, Mizuno N, Hijioka S, Hara K, Yazumi S, Shimizu Y, Yamao K. Clinical outcome of elderly patients with unresectable pancreatic cancer treated with gemcitabine plus S-1, S-1 alone, or gemcitabine alone: Subgroup analysis of a randomised phase III trial, GEST study. Eur J Cancer. 2016 Feb;54:96-103. doi: 10.1016/j.ejca.2015.11.002. Epub 2015 Dec 30.
• Wang Z, Liu Y, Li R, Shang Y, Zhang Y, Zhao L, Li W, Yang Y, Zhang X, Yang T, Nie C, Han F, Liu Y, Luo S, Gao Q, Song Y. Autologous cytokine-induced killer cell transfusion increases overall survival in advanced pancreatic cancer. J Hematol Oncol. 2016 Feb 3;9:6. doi: 10.1186/s13045-016-0237-6.

Study record dates

Study Major Dates

• Study Start: November 1, 2016
• Primary Completion (ACTUAL): October 1, 2019
• Study Completion (ACTUAL): October 1, 2019

Study Registration Dates

• First Submitted: December 19, 2016
• First Submitted That Met QC Criteria: December 23, 2016
• First Posted (ESTIMATE): December 26, 2016

Study Record Updates

• Last Update Posted (ACTUAL): April 2, 2020
• Last Update Submitted That Met QC Criteria: March 31, 2020
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Keywords: Pancreatic Cancer; Chemotherapy; CIK
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Endocrine System Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Pancreatic Diseases; Pancreatic Neoplasms; Molecular Mechanisms of Pharmacological Action; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Tegafur
• Other Study ID Numbers: HenanCH CIK02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO