Safety and Efficacy Study for MG-7-DC Vaccine in Gastric Cancer Treatment
Phase I/II Study of DC Vaccine Targeting MG-7 Antigen to Treat Gastric Cancer
1 other identifier
interventional
45
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 gastric-cancer
Started Sep 2020
Shorter than P25 for phase_1 gastric-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2020
CompletedFirst Submitted
Initial submission to the registry
September 23, 2020
CompletedFirst Posted
Study publicly available on registry
September 28, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2022
CompletedSeptember 28, 2020
September 1, 2020
1.2 years
September 23, 2020
September 25, 2020
Conditions
Keywords
Outcome Measures
Primary 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.
6 months
Disease Control Rate (DCR) (PR+CR+SD)
The proportion of patients with complete response (CR), partial response (PR), or stable disease (SD).
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.
6 months
Health-related quality of life (QoL): 36-Item Short Form (SF-36)
Medical Outcomes Study 36-Item Short Form (SF-36)
6 months
Secondary Outcomes (4)
Objective Response Rate (ORR) (PR+CR)
12 months
Disease Control Rate (DCR) (PR+CR+SD)
12 months
Progression-free Survival (PFS)
12 months
Health-related quality of life (QoL): 36-Item Short Form (SF-36)
12 months
Study Arms (3)
DC vaccine
EXPERIMENTALVaccine made from autologous dendritic cells loaded with MG-7 antigen.
DC vaccine + CTL (cytotoxic lymphocyte)
EXPERIMENTALCytotoxic lymphocytes are CD3+ T cells co-cultured with DCs.
DC vaccine + PD-1 monoclonal antibody (Sintilimab Injection)
EXPERIMENTALSintilimab 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.
Interventions
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.
Four intravenous (iv) drip injections of CTL will be given at days 7, 9, 27, 29; 1-2×109 cells/time.
The Sintilimab Injection (3mg/kg) will be administered by intravenous (iv) drip injection at days 0, 20。
Eligibility Criteria
You may qualify if:
- 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.
- 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;
- +4 more criteria
You may not qualify if:
- 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
- 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 .
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The 2nd Hospital of Shandong University
Jinan, Shandong, 250033, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 23, 2020
First Posted
September 28, 2020
Study Start
September 1, 2020
Primary Completion
December 1, 2021
Study Completion
June 1, 2022
Last Updated
September 28, 2020
Record last verified: 2020-09