Gastric CancerPhase 1/2NCT04567069
Safety and Efficacy Study for MG-7-DC Vaccine in Gastric Cancer Treatment
A Phase 1/2 study testing DC vaccine, CTL and Sintilimab Injection in people with Gastric Cancer, run by The Second Hospital of Shandong University at 1 site in China.
Trial summary
The primary purpose of the study is to determine the safety and efficacy of autologous DC vaccine in patients with later stage of gastric cancer. The DC vaccine is gene modified with gastric cancer specific antigen MG-7. 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?
- DC vaccine, CTL and Sintilimab Injection
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteChina
- Study dates
- Sep 2020to Jun 2022
- Phase
- Phase 1/2
- 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
- Pathologically or cytologically confirmed gastric adenocarcinoma.
- Patients should be within age range of ≥18 and ≤80 years old, competent, have signed informed consent and have a life expectancy greater than 6 months.
- Failed in previous standard therapy ( surgery, chemotherapy, radiotherapy, and targeted therapy) or recurred from previous therapy, patients must be at least 1 month from their last therapy.
- Patients without indications of surgery, radiotherapy or chemotherapy.
- Patients who can't tolerate radiotherapy or chemotherapy.
- Patients who refuse radiotherapy or chemotherapy.
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- Have measurable lesion by RECIST 1.1 criteria.
- Karnofsky Performance Status (KPS) ≥60.
- Patients must be willing to enroll the clinical study, and comply with the study and follow-up procedures.
- Adequate organ and bone marrow functions:
- White Blood Count (WBC) ≥ 3,000/mm3 (3.0×109/L);
- Neutrophils≥ 1,000/mm3 (1.0×109/L);
- Platelets (PLT) ≥ 80,000/mm3 (80×109/L);
- Hemoglobin（Hb）≥ 9 g/dL (90g/L);
- Serum creatinine ≤ 1.5x the upper limit of normal (ULN) or creatinine clearance (CrCl)≥ 40 mL/min;
- Bilirubin≤ 1.5x ULN;
- Aspartate Aminotransferase (AST) ≤ 2.5x ULN or Alanine Aminotransferase (ALT) ≤ 2.5x ULN; patients with liver metastasis must be ≤5x ULN;
- International normalized ratio (INR) ≤ 1.5, prothrombin time (PT) and activated partial thromboplastin time (APTT) ≤ 1.5 times ULN;
- Urine protein < 2 +; if urinary protein ≥ 2 +, the 24-hour urine protein quantification must be ≤ 1g.
Who cannot join
- Other diseases that may have influence on this study ( such as active infection, symptomatic myocardial infarction, angina pectoris, arrhythmia, etc.).
- Patients who received systemic anti-tumor therapy and local treatment (radiotherapy, ablation and embolization) for gastric cancer within 1 month.
- Patients who have active autoimmune diseases and need systemic immunosuppressive therapy.
- Life expectancy < 6 months.
- Patients with organ allografts.
- Women who are pregnant or nursing/breastfeeding
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- Allergic to allogeneic protein.
- Human immunodeficiency virus (HIV) infection, untreated active hepatitis (hepatitis B, defined as HBV-DNA ≥ 500 IU / ml; hepatitis C, defined as HCV-RNA higher than the detection limit of the analytical method).
- For any other reasons, the patients are believed not suitable for participation in this study by investigators .
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The 2nd Hospital of Shandong University
Jinan, Shandong, 250033
Chengyun Zheng, Ph.D., +86-531-85875502, zhengchengyun186@126.com
About this study
Official title: Phase I/II Study of DC Vaccine Targeting MG-7 Antigen to Treat Gastric Cancer
The primary purpose of the study is to determine the safety and efficacy of autologous DC vaccine in patients with later stage of gastric cancer. The DC vaccine is gene modified with gastric cancer specific antigen MG-7.
Read the detailed description
All eligible patients will receive two cycles of treatment, every 21 days is a treatment cycle. The follow-up time will start from the next day after the end of the second cycle of treatment, and last for 48 ±1 weeks (the follow-up time is 4 weeks, 12 weeks, 24 weeks, 36 weeks, 48 weeks). During the treatment and follow-up period, if disease progression or intolerable side effects develop, the patient can voluntarily request to be withdrawn from the study, or the investigators can determine that the patient be removed from the study.
DC and CTL are immune cells. PD-1 monoclonal antibody is an immune checkpoint inhibitor. According to the relevant experience of similar cells or drugs, some patients may have delayed or early pseudo-tumor progression after receiving immunotherapy, which needs to be judged by investigators.
In this study, the screening period is no more than 14 days. After the screening examination and evaluation, the eligible patients will enter the treatment period. The treatment and follow-up are carried out according to the procedure. The follow-up period: tumor imaging evaluation and related clinical indicator evaluation are carried out at the 4th week (± 1 week), the 12th week (± 1 week), the 24th week (± 1 week), the 36th week (± 1 week) and the 48th week (± 1 week) after the treatment. The patients should also complete the corresponding safety inspection and evaluation before leaving the group. During the follow-up period, the patients who do not have disease progression but do leave the group should continue to be evaluated according to the original frequency until the end of the follow-up period or the start of other anti-tumor treatment.
- Conditions
- Gastric Cancer
- Being tested
- DC vaccine, CTL, Sintilimab Injection
- Keywords
- gastric cancer, DC vaccine, CTL, MG-7 antigen, PD-1 monoclonal antibody
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DC vaccineBiological
Also called MG-7-DC vaccine, MG-7 antigen-pulsed autologous DC vaccine
Blood samples will be collected twice, 60-120ml/ time. The 1st collection will occur 5 days before the 1st DC vaccine injection, the 2nd collection will occur 15 days after the 1st injection.
Six subcutaneous(ih) injections of DC vaccine will be given at days 1, 8, 15, 21, 28, 35; 1-3×106 cells/time.
Injection site: inguinal lymph nodes.
CTLBiological
Four intravenous (iv) drip injections of CTL will be given at days 7, 9, 27, 29; 1-2×109 cells/time.
Sintilimab InjectionDrug
Also called Sintilimab, Tyvyt
The Sintilimab Injection (3mg/kg) will be administered by intravenous (iv) drip injection at days 0, 20。
| Study group | Role | What they receive |
|---|---|---|
| DC vaccine | Experimental | Vaccine made from autologous dendritic cells loaded with MG-7 antigen. Receives: Biological: DC vaccine |
| DC vaccine + CTL (cytotoxic lymphocyte) | Experimental | Cytotoxic lymphocytes are CD3+ T cells co-cultured with DCs. Receives: Biological: DC vaccine; Biological: CTL |
| DC vaccine + PD-1 monoclonal antibody (Sintilimab Injection) | Experimental | Sintilimab injection is a type of immunoglobulin G4 monoclonal antibody, which binds to PD-1 molecules on the surface of T-cells, blocks the PD-1/ PD-1 Ligand-1 (PD-L1) pathway and reactivates T-cells to kill cancer cells. Receives: Biological: DC vaccine; Drug: Sintilimab Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR) (PR+CR)
The proportion of patients with complete response(CR) or partial response(PR) as measured by RECIST 1.1 criteria.
Measured: 6 months
Disease Control Rate (DCR) (PR+CR+SD)
The proportion of patients with complete response (CR), partial response (PR), or stable disease (SD).
Measured: 6 months
Progression-free Survival (PFS)
The length of time during and after the treatment, that a patient lives with the disease but it does not get worse.
Measured: 6 months
Health-related quality of life (QoL): 36-Item Short Form (SF-36)
Medical Outcomes Study 36-Item Short Form (SF-36)
Measured: 6 months
Secondary outcomes (4)
Objective Response Rate (ORR) (PR+CR)
The proportion of patients with complete response(CR) or partial response(PR) as measured by RECIST 1.1 criteria.
Measured: 12 months
Disease Control Rate (DCR) (PR+CR+SD)
The proportion of patients with complete response (CR), partial response (PR), or stable disease (SD).
Measured: 12 months
Progression-free Survival (PFS)
The length of time during and after the treatment, that a patient lives with the disease but it does not get worse.
Measured: 12 months
Health-related quality of life (QoL): 36-Item Short Form (SF-36)
Medical Outcomes Study 36-Item Short Form (SF-36)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2020
- Study startSep 2020 (estimated)
- Primary completionDec 2021 (estimated)
- Study completionJun 2022 (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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Second Hospital of Shandong University
- Sponsor type
- University, hospital or other
- Collaborators
- Shandong Sunstem Biotechnology Co.,Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04567069
- Sponsor's protocol ID
- DC-S-Ⅰ/Ⅱ
- Status last verified
- Sep 2020
- First submitted
- 23 Sep 2020
- Last updated
- 28 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Study of DC Vaccine Targeting MG-7 Antigen to Treat Gastric Cancer
- ClinicalTrials.gov ID
- NCT04567069
- Acronym / sponsor ID
- DC-S-Ⅰ/Ⅱ
- Conditions
- Gastric Cancer
- Keywords
- gastric cancer, DC vaccine, CTL, MG-7 antigen, PD-1 monoclonal antibody
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- The Second Hospital of Shandong UniversityUniversity, hospital or other
- Collaborators
- Shandong Sunstem Biotechnology Co.,Ltd.
- Study start
- Sep 2020 (estimated)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Jun 2022 (estimated)
- First posted
- 28 Sep 2020 (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.
The primary purpose of the study is to determine the safety and efficacy of autologous DC vaccine in patients with later stage of gastric cancer. The DC vaccine is gene modified with gastric cancer specific antigen MG-7.
Detailed description
All eligible patients will receive two cycles of treatment, every 21 days is a treatment cycle. The follow-up time will start from the next day after the end of the second cycle of treatment, and last for 48 ±1 weeks (the follow-up time is 4 weeks, 12 weeks, 24 weeks, 36 weeks, 48 weeks). During the treatment and follow-up period, if disease progression or intolerable side effects develop, the patient can voluntarily request to be withdrawn from the study, or the investigators can determine that the patient be removed from the study.
DC and CTL are immune cells. PD-1 monoclonal antibody is an immune checkpoint inhibitor. According to the relevant experience of similar cells or drugs, some patients may have delayed or early pseudo-tumor progression after receiving immunotherapy, which needs to be judged by investigators.
In this study, the screening period is no more than 14 days. After the screening examination and evaluation, the eligible patients will enter the treatment period. The treatment and follow-up are carried out according to the procedure. The follow-up period: tumor imaging evaluation and related clinical indicator evaluation are carried out at the 4th week (± 1 week), the 12th week (± 1 week), the 24th week (± 1 week), the 36th week (± 1 week) and the 48th week (± 1 week) after the treatment. The patients should also complete the corresponding safety inspection and evaluation before leaving the group. During the follow-up period, the patients who do not have disease progression but do leave the group should continue to be evaluated according to the original frequency until the end of the follow-up period or the start of other anti-tumor treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| DC vaccine | Experimental | Biological: DC vaccineVaccine made from autologous dendritic cells loaded with MG-7 antigen. |
| DC vaccine + CTL (cytotoxic lymphocyte) | Experimental | Biological: DC vaccine, Biological: CTLCytotoxic lymphocytes are CD3+ T cells co-cultured with DCs. |
| DC vaccine + PD-1 monoclonal antibody (Sintilimab Injection) | Experimental | Biological: DC vaccine, Drug: Sintilimab InjectionSintilimab injection is a type of immunoglobulin G4 monoclonal antibody, which binds to PD-1 molecules on the surface of T-cells, blocks the PD-1/ PD-1 Ligand-1 (PD-L1) pathway and reactivates T-cells to kill cancer cells. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Pathologically or cytologically confirmed gastric adenocarcinoma.
- Patients should be within age range of ≥18 and ≤80 years old, competent, have signed informed consent and have a life expectancy greater than 6 months.
- Failed in previous standard therapy ( surgery, chemotherapy, radiotherapy, and targeted therapy) or recurred from previous therapy, patients must be at least 1 month from their last therapy.
- Patients without indications of surgery, radiotherapy or chemotherapy.
- Patients who can't tolerate radiotherapy or chemotherapy.
Key exclusion criteria (9 listed)
- Other diseases that may have influence on this study ( such as active infection, symptomatic myocardial infarction, angina pectoris, arrhythmia, etc.).
- Patients who received systemic anti-tumor therapy and local treatment (radiotherapy, ablation and embolization) for gastric cancer within 1 month.
- Patients who have active autoimmune diseases and need systemic immunosuppressive therapy.
- Life expectancy < 6 months.
- Patients with organ allografts.
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 |
|---|---|---|
| DC vaccineAlso: MG-7-DC vaccine, MG-7 antigen-pulsed autologous DC vaccineBlood samples will be collected twice, 60-120ml/ time. The 1st collection will occur 5 days before the 1st DC vaccine injection, the 2nd collection will occur 15 days after the 1st injection. Six subcutaneous(ih) injections of DC vaccine will be given at days 1, 8, 15, 21, 28, 35; 1-3×106 cells/time. Injection site: inguinal lymph nodes. | Biological | DC vaccine, DC vaccine + CTL (cytotoxic lymphocyte), DC vaccine + PD-1 monoclonal antibody (Sintilimab Injection) |
| CTLFour intravenous (iv) drip injections of CTL will be given at days 7, 9, 27, 29; 1-2×109 cells/time. | Biological | DC vaccine + CTL (cytotoxic lymphocyte) |
| Sintilimab InjectionAlso: Sintilimab, TyvytThe Sintilimab Injection (3mg/kg) will be administered by intravenous (iv) drip injection at days 0, 20。 | Drug | DC vaccine + PD-1 monoclonal antibody (Sintilimab Injection) |
Primary outcome
Objective Response Rate (ORR) (PR+CR)
Time frame: 6 months
The proportion of patients with complete response(CR) or partial response(PR) as measured by RECIST 1.1 criteria.
Disease Control Rate (DCR) (PR+CR+SD)
Time frame: 6 months
The proportion of patients with complete response (CR), partial response (PR), or stable disease (SD).
Progression-free Survival (PFS)
Time frame: 6 months
The length of time during and after the treatment, that a patient lives with the disease but it does not get worse.
Health-related quality of life (QoL): 36-Item Short Form (SF-36)
Time frame: 6 months
Medical Outcomes Study 36-Item Short Form (SF-36)
4 secondary outcomes
Objective Response Rate (ORR) (PR+CR)
Time frame: 12 months
Disease Control Rate (DCR) (PR+CR+SD)
Time frame: 12 months
Progression-free Survival (PFS)
Time frame: 12 months
Health-related quality of life (QoL): 36-Item Short Form (SF-36)
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2020.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing DC vaccine, CTL and Sintilimab Injection in people with Gastric Cancer, run by The Second Hospital of Shandong 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 19 inclusion and 9 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 28 Sep 2020. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 Chengyun Zheng, Ph.D (+86-531-85875502, zhengchengyun186@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) (PR+CR) (time frame: 6 months). The study lists 4 primary outcomes in all. 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 28 Sep 2020.