Back to resultsDendritic Cell-based Immunotherapy in Treatment Gastric Cancer
Primary Purpose
Gastric Cancer
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
activated DCs
radical surgery only
Sponsored by
About this trial
This is an interventional treatment trial for Gastric Cancer focused on measuring dendritic cell, immunotherapy, tumor cell membrane proteins
Eligibility Criteria
Inclusion Criteria:
- Written informed consent given before any trial-specific procedure is initiated
- Male or female, at least 18 years of age at the time of informed consent
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1
- Life expectancy >3 months assessed during Screening
- Documented (histologically- or cytologically-proven) gastric cancer that is can be radially removed
Exclusion Criteria:
- Non-healing wounds on any part of the body
- Active thrombosis, or a history of deep vein thrombosis or pulmonary embolism, within 1 month prior to surgery, unless adequately treated and stable
- Active uncontrolled bleeding or a known bleeding diathesis
Significant cardiovascular disease or condition, including:
- Congestive heart failure currently requiring therapy
- Class III or IV cardiovascular disease according to the New York Heart Association's (NYHA) functional criteria (25)
- Need for antiarrhythmic medical therapy for a ventricular arrhythmia
- Severe conduction disturbance (e.g., 3rd degree heart block)
- Unstable angina pectoris (last episode at least 6 months prior to surgery)
- Uncontrolled hypertension (per the Investigator's discretion)
- Myocardial infarction within 6 months prior to C1/D1
Abnormal hematologic, renal or hepatic function as defined by the following criteria:
- Absolute neutrophil count (ANC) <1.5 ×109/L (1500/mm3)
- Hemoglobin ≤9 g/dL
- Platelet count <75 ×109/L (75,000/mm3)
- Serum creatinine >1.5 × upper limit of normal (ULN) for the institution
- Aspartate aminotransferase (AST) >3.5 × ULN for the institution or AST >5 × ULN for the institution in case of known liver metastases
- Alanine aminotransferase (ALT) >3.5 × ULN for the institution or ALT >5 × ULN for the institution in case of known liver metastases
- Total bilirubin >1.5 × ULN for the institution
- Prothrombin time as assessed by International Normalized Ratio (INR) >1.5 × ULN for the institution*
- Partial thromboplastin time (PTT) >1.5 × ULN for the institution*
Any of the following within 2 weeks prior to surgery:
- Any serious or uncontrolled infection
- Any infection requiring parenteral antibiotics
- Unexplained fever >38.0 °C
- Any other life-threatening illness, significant organ system dysfunction, or clinically significant laboratory abnormality, which in the opinion of the Investigator, would either compromise the patient's safety or interfere with the evaluation of the safety of the trial treatment
- Any kind of disorder that compromises the ability of the patient to give written informed consent and/or to comply with trial procedures or is unwilling or unable to comply with trial requirements at the discretion of the Investigator
- Breast feeding, or plans by the patient (or the patient's partner) to become pregnant during treatment or within 4 months after the end of treatment
Sites / Locations
- Lanzhou University Second HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Radical surgery plus activated DCs
Radical surgery only
Arm Description
In 21 days after a radical surgery, activated DCs are iv infused
Radical surgery only group as a control group
Outcomes
Primary Outcome Measures
progression-free survival
Time to progression/death or censored time
Secondary Outcome Measures
recurrent rate
the rate of cancer recurring after surgery
overall survival rate
time to death or censored time
immune-cells response
CD4/CD8 T lymphocyte percentage change
Adverse event rate
Adverse event rate
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03410732
Brief Title
Dendritic Cell-based Immunotherapy in Treatment Gastric Cancer
Official Title
Activated Autologous Dendritic Cells by Autologous Tumor Cell Membrane Proteins in Treatment of Gastric Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2017 (Actual)
Primary Completion Date
July 1, 2020 (Anticipated)
Study Completion Date
December 1, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
LanZhou University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Study objectives are to investigate the efficacy and safety of activated autologous dendritic cells (DCs) in treatment of gastric cancer. DCs are activated by the proteins from autologous tumor cell membrane and cytokines in vitro. The efficacy endpoints include objective response, immune-cell response, recurrent rate after a radical surgery, progression-free survival and overall survival, and the safety endpoints include adverse events, laboratory tests, ECG, ECOG-PT, etc.
Detailed Description
Study objectives are to investigate the efficacy and safety of activated autologous dendritic cells (DCs) in treatment of gastric cancer. The autologous DCs are collected and enriched from peripheral blood, and then are activated by the proteins from autologous tumor cell membrane and cytokines in vitro. The efficacy endpoints include objective response, immune-cell response, recurrent rate after a radical surgery, progression-free survival and overall survival, and the safety endpoints include adverse events, laboratory tests, ECG, ECOG-PT, etc. All patients will be followed up for at least 2 years after treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer
Keywords
dendritic cell, immunotherapy, tumor cell membrane proteins
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Radical surgery plus activated DCs
Arm Type
Experimental
Arm Description
In 21 days after a radical surgery, activated DCs are iv infused
Arm Title
Radical surgery only
Arm Type
Active Comparator
Arm Description
Radical surgery only group as a control group
Intervention Type
Biological
Intervention Name(s)
activated DCs
Other Intervention Name(s)
activated DCs by autologous tumor cell membrane proteins
Intervention Description
autologous dendritic cells are collected and enriched from 50 ml of peripheral blood, then activated by autologous tumor cell membrane proteins. Then the activated DCs are iv infused in 21 days after a radical surgery.
Intervention Type
Procedure
Intervention Name(s)
radical surgery only
Intervention Description
Only radical surgery is given to the control group
Primary Outcome Measure Information:
Title
progression-free survival
Description
Time to progression/death or censored time
Time Frame
3 years
Secondary Outcome Measure Information:
Title
recurrent rate
Description
the rate of cancer recurring after surgery
Time Frame
3 years
Title
overall survival rate
Description
time to death or censored time
Time Frame
5 years
Title
immune-cells response
Description
CD4/CD8 T lymphocyte percentage change
Time Frame
3 months
Title
Adverse event rate
Description
Adverse event rate
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Written informed consent given before any trial-specific procedure is initiated
Male or female, at least 18 years of age at the time of informed consent
Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1
Life expectancy >3 months assessed during Screening
Documented (histologically- or cytologically-proven) gastric cancer that is can be radially removed
Exclusion Criteria:
Non-healing wounds on any part of the body
Active thrombosis, or a history of deep vein thrombosis or pulmonary embolism, within 1 month prior to surgery, unless adequately treated and stable
Active uncontrolled bleeding or a known bleeding diathesis
Significant cardiovascular disease or condition, including:
Congestive heart failure currently requiring therapy
Class III or IV cardiovascular disease according to the New York Heart Association's (NYHA) functional criteria (25)
Need for antiarrhythmic medical therapy for a ventricular arrhythmia
Severe conduction disturbance (e.g., 3rd degree heart block)
Unstable angina pectoris (last episode at least 6 months prior to surgery)
Uncontrolled hypertension (per the Investigator's discretion)
Myocardial infarction within 6 months prior to C1/D1
Abnormal hematologic, renal or hepatic function as defined by the following criteria:
Absolute neutrophil count (ANC) <1.5 ×109/L (1500/mm3)
Hemoglobin ≤9 g/dL
Platelet count <75 ×109/L (75,000/mm3)
Serum creatinine >1.5 × upper limit of normal (ULN) for the institution
Aspartate aminotransferase (AST) >3.5 × ULN for the institution or AST >5 × ULN for the institution in case of known liver metastases
Alanine aminotransferase (ALT) >3.5 × ULN for the institution or ALT >5 × ULN for the institution in case of known liver metastases
Total bilirubin >1.5 × ULN for the institution
Prothrombin time as assessed by International Normalized Ratio (INR) >1.5 × ULN for the institution*
Partial thromboplastin time (PTT) >1.5 × ULN for the institution*
Any of the following within 2 weeks prior to surgery:
Any serious or uncontrolled infection
Any infection requiring parenteral antibiotics
Unexplained fever >38.0 °C
Any other life-threatening illness, significant organ system dysfunction, or clinically significant laboratory abnormality, which in the opinion of the Investigator, would either compromise the patient's safety or interfere with the evaluation of the safety of the trial treatment
Any kind of disorder that compromises the ability of the patient to give written informed consent and/or to comply with trial procedures or is unwilling or unable to comply with trial requirements at the discretion of the Investigator
Breast feeding, or plans by the patient (or the patient's partner) to become pregnant during treatment or within 4 months after the end of treatment
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yumin Li, MD, PhD
Phone
+8613893615421
Email
liym@lzu.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Gui Gao, MD, PhD
Phone
+86-931-8942281
Email
Scottgao1110@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yumin Li
Organizational Affiliation
Second Hospital of Lanzhou University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lanzhou University Second Hospital
City
Lanzhou
State/Province
Gansu
ZIP/Postal Code
730030
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yumin Li, MD, PhD
Phone
+8613893615421
Email
liym@lzu.edu.cn
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
we'll update the registration system. But final data will be summarized and published in a medical journal
Learn more about this trial
Dendritic Cell-based Immunotherapy in Treatment Gastric Cancer
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