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

Phase 2

Terminated

• Conditions: Advanced Cancer
• Interventions: Biological: Cytokine-induced Killer Cells; Drug: Tegafur-Gimeracil-Oteracil Potassium

• Registration Number: NCT03002831
• Lead Sponsor: Henan Cancer Hospital

Brief 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.

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 Timeline

• Study Start: 2016-11
• Status Verified: 2016-12
• Study First Submitted: 2016-12-19
• Study First Submitted QC: 2016-12-23
• Study First Posted: 2016-12-26
• Primary Completion: 2019-10
• Study Completion: 2019-10
• Last Update Submitted: 2020-03-31
• Last Update Posted: 2020-04-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 13

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CIK combined chemotherapy	Cytokine-induced Killer Cells	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.
CIK combined chemotherapy	Tegafur-Gimeracil-Oteracil Potassium	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.
Chemotherapy	Tegafur-Gimeracil-Oteracil Potassium	Tegafur,Gimeracil and Oteracil Potassium Capsules 40-60mg, bid, po, D1-14, Q3w

Primary Outcome Measures

Name	Time	Method
Overall Survival	From the date of randomization to the date of death from any cause up to 36 months

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital; 🇨🇳 Zhengzhou, Henan, China