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

NCT01781520 | Completed Phase 1

• 1 other identifier: S1+DC CIK-P
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

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

Keywords

Pancreatic Cancer; S1; DC-CIK

Outcome Measures

Primary Outcomes (1)

• Treatment toxicity

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

  4 years

Secondary Outcomes (5)

• The disease control rate

  4 years

• Progression free survival（PFS）

  4 years

• Overal survival(OS)

  4 years

• Changing trend of tumor biomarkers

  4 years

• Phenotypic analysis of peripheral blood immune cells

  4 years

Study Arms (4)

S-1 plus DC-CIK

EXPERIMENTAL

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.

Biological: DC-CIK Treatment; Drug: S1

DC-CIK alone

ACTIVE COMPARATOR

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.

Biological: DC-CIK Treatment

S-1 alone

ACTIVE COMPARATOR

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.

Drug: S1

Best supportive care

ACTIVE COMPARATOR

Other: Best supportive care

Interventions

DC-CIK Treatment BIOLOGICAL

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

DC-CIK alone; S-1 plus DC-CIK

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.

S-1 alone; S-1 plus DC-CIK

Best supportive care OTHER

Best supportive care

Best supportive care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Capital Medical University: lead

Study Sites (1)

Capital Medical University Cancer Center

Beijing, Beijing Municipality, 100038, China

Location

Related Publications (1)

• 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.

  PMID: 28611200 RESULT

Related Links

• Published article for this study

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

S 1 (combination)

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director,Capital Medical University (CMU)Cancer Center

Study Record Dates

• First Submitted: January 30, 2013
• First Posted: February 1, 2013
• Study Start: June 1, 2013
• Primary Completion: May 30, 2016
• Study Completion: June 13, 2017
• Last Updated: January 18, 2018

Record last verified: 2018-01

Locations

CN (1)