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

NCT ID: NCT01781520

Last Updated: 2018-01-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 47 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-06-01
• Study Completion Date: 2017-06-13

Brief 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.

Conditions

Pancreatic Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

S-1 plus DC-CIK

Chemotherapy: S-1 is administered orally twice daily at a dose of 80,100, or 120mg/day for body surface areas of less than 1.25m2, between 1.25m2 and less than 1.5, or 1.5m2 or greater, respectively, for 14 consecutive days, followed by a 7-day rest, repeated every 3 weeks.

DC-CIK Immunotherapy:Mononuclear cells were collected aseptically with blood cell separator composition aphaeresis, and then cultured DC-CIK cells were infused back to the patients on days 15, 17, and 19 of 21-day cycles.

Group Type: EXPERIMENTAL

DC-CIK Treatment

Intervention Type: BIOLOGICAL

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

S1

Intervention Type: 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.

DC-CIK alone

DC-CIK Immunotherapy:Mononuclear cells were collected aseptically with blood cell separator composition aphaeresis, and then cultured DC-CIK cells were infused back to the patients on days 15, 17, and 19 of 21-day cycles.

Group Type: ACTIVE_COMPARATOR

DC-CIK Treatment

Intervention Type: BIOLOGICAL

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

S-1 alone

Chemotherapy: S-1 is administered orally twice daily at a dose of 80,100, or 120mg/day for body surface areas of less than 1.25m2, between 1.25m2 and less than 1.5, or 1.5m2 or greater, respectively, for 14 consecutive days, followed by a 7-day rest, repeated every 3 weeks.

Group Type: ACTIVE_COMPARATOR

S1

Intervention Type: 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

Group Type: ACTIVE_COMPARATOR

Best supportive care

Intervention Type: OTHER

Best supportive care

Interventions

DC-CIK Treatment

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

Intervention Type: BIOLOGICAL

S1

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.

Intervention Type: DRUG

Best supportive care

Best supportive care

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Capital Medical University

OTHER

Sponsor Role: lead

Responsible Party

Jun Ren MD, PhD

Director,Capital Medical University (CMU)Cancer Center

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Capital Medical University Cancer Center

Beijing, Beijing Municipality, China

Countries

China

References

Jiang N, Qiao G, Wang X, Morse MA, Gwin WR, Zhou L, Song Y, Zhao Y, Chen F, Zhou X, Huang L, Hobeika A, Yi X, Xia X, Guan Y, Song J, Ren J, Lyerly HK. Dendritic Cell/Cytokine-Induced Killer Cell Immunotherapy Combined with S-1 in Patients with Advanced Pancreatic Cancer: A Prospective Study. Clin Cancer Res. 2017 Sep 1;23(17):5066-5073. doi: 10.1158/1078-0432.CCR-17-0492. Epub 2017 Jun 13.

Reference Type: RESULT

PMID: 28611200 (View on PubMed)

Related Links

http://www.ncbi.nlm.nih.gov/pubmed/?term=Dendritic+Cell%2FCytokine-Induced+Killer+CellImmunotherapy+Combined+with+S-1+in+Patients+with+Advanced+Pancreatic+Cancer%3AA+Prospective+Study

Published article for this study

Other Identifiers

S1+DC CIK-P

Identifier Type: -

Identifier Source: org_study_id