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

Advanced Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03002831
• Other study ID #: HenanCH CIK02
• Status: Terminated
• Phase: Phase 2
• Start date: November 2016
• Est. completion date: October 2019

Study information

• Verified date: December 2016
• Source: Henan Cancer Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 13
• Est. completion date: October 2019
• Est. primary completion date: October 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Advanced Cancer
• Pancreatic Neoplasms

Intervention

Biological:
• Cytokine-induced Killer Cells

Drug:
• Tegafur-Gimeracil-Oteracil Potassium

Locations

Country	Name	City	State
China	Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Henan Cancer Hospital

Country where clinical trial is conducted

China, 

References & Publications (2)

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 o — View Citation

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 Fe — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival		From the date of randomization to the date of death from any cause up to 36 months
Secondary	Progression Free Survival		From the date of randomization to the date of first documented progression up to 24 months
Secondary	Quality of life assessed by Questionnaire		one year by questionnaire