Gastric CancerPhase 2NCT03410732
Dendritic Cell-based Immunotherapy in Treatment Gastric Cancer
A Phase 2 study testing activated DCs and radical surgery only in people with Gastric Cancer, run by LanZhou University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- activated DCs and radical surgery only
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2017to 1 Dec 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 28Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Lanzhou University Second Hospital
Lanzhou, Gansu, 730030
Yumin Li, MD, PhD, +8613893615421, liym@lzu.edu.cn
About this study
Official title: Activated Autologous Dendritic Cells by Autologous Tumor Cell Membrane Proteins in Treatment of Gastric Cancer
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.
Read the 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.
- Conditions
- Gastric Cancer
- Being tested
- activated DCs, radical surgery only
- Keywords
- dendritic cell, immunotherapy, tumor cell membrane proteins
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
activated DCsBiological
Also called activated DCs by autologous tumor cell membrane proteins
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.
radical surgery onlyProcedure or surgery
Only radical surgery is given to the control group
| Study group | Role | What they receive |
|---|---|---|
| Radical surgery plus activated DCs | Experimental | In 21 days after a radical surgery, activated DCs are iv infused Receives: Biological: activated DCs; Procedure: radical surgery only |
| Radical surgery only | Active comparator | Radical surgery only group as a control group Receives: Procedure: radical surgery only |
What is being measured
The primary outcome is the main question the study is designed to answer.
progression-free survival
Time to progression/death or censored time
Measured: 3 years
Secondary outcomes (4)
recurrent rate
the rate of cancer recurring after surgery
Measured: 3 years
overall survival rate
time to death or censored time
Measured: 5 years
immune-cells response
CD4/CD8 T lymphocyte percentage change
Measured: 3 months
Adverse event rate
Adverse event rate
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2018
- Study start1 Jul 2017
- Primary completion1 Jul 2020 (estimated)
- Study completion1 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- LanZhou University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gui Gao, Ph D, MD, LanZhou University
- Investigators
- Yumin Li, Principal investigator, Lanzhou University Second Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03410732
- Sponsor's protocol ID
- LAUDC 2017001
- Status last verified
- Jan 2018
- First submitted
- 16 Jan 2018
- Last updated
- 25 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: we'll update the registration system. But final data will be summarized and published in a medical journal
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Activated Autologous Dendritic Cells by Autologous Tumor Cell Membrane Proteins in Treatment of Gastric Cancer
- ClinicalTrials.gov ID
- NCT03410732
- Acronym / sponsor ID
- LAUDC 2017001
- Conditions
- Gastric Cancer
- Keywords
- dendritic cell, immunotherapy, tumor cell membrane proteins
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- LanZhou UniversityUniversity, hospital or other
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 1 Jul 2020 (estimated)
- Study completion
- 1 Dec 2020 (estimated)
- First posted
- 25 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Radical surgery plus activated DCs | Experimental | Biological: activated DCs, Procedure: radical surgery onlyIn 21 days after a radical surgery, activated DCs are iv infused |
| Radical surgery only | Active comparator | Procedure: radical surgery onlyRadical surgery only group as a control group |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (28 listed)
- 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:
- Abnormal hematologic, renal or hepatic function as defined by the following criteria:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| activated DCsAlso: activated DCs by autologous tumor cell membrane proteinsautologous 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. | Biological | Radical surgery plus activated DCs |
| radical surgery onlyOnly radical surgery is given to the control group | Procedure or surgery | Radical surgery only, Radical surgery plus activated DCs |
Primary outcome
progression-free survival
Time frame: 3 years
Time to progression/death or censored time
4 secondary outcomes
recurrent rate
Time frame: 3 years
overall survival rate
Time frame: 5 years
immune-cells response
Time frame: 3 months
Adverse event rate
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2018.
- Individual participant dataSharing planned: Undecided. we'll update the registration system. But final data will be summarized and published in a medical journal
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yumin Li principal investigator
Lanzhou University Second Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing activated DCs and radical surgery only in people with Gastric Cancer, run by LanZhou University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yumin Li, MD, PhD (+8613893615421, liym@lzu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
progression-free survival (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2018.