Safety and Efficacy Study for MG-7-DC Vaccine in Gastric Cancer Treatment

• Status: Recruiting
• Trial end date: 2022-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Second Hospital of Shandong University
• Collaborator: Shandong Sunstem Biotechnology Co.,Ltd.
• Treatments: Vaccines

Criteria

Inclusion Criteria:

1. Pathologically or cytologically confirmed gastric adenocarcinoma.

2. 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.

3. 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.

4. Patients without indications of surgery, radiotherapy or chemotherapy.

5. Patients who can't tolerate radiotherapy or chemotherapy.

6. Patients who refuse radiotherapy or chemotherapy.

7. Have measurable lesion by RECIST 1.1 criteria.

8. Karnofsky Performance Status (KPS) ≥60.

9. Patients must be willing to enroll the clinical study, and comply with the study and follow-up procedures.

10. Adequate organ and bone marrow functions:

1. White Blood Count (WBC) ≥ 3,000/mm3 (3.0×109/L);

2. Neutrophils≥ 1,000/mm3 (1.0×109/L);

3. Platelets (PLT) ≥ 80,000/mm3 (80×109/L);

4. Hemoglobin（Hb）≥ 9 g/dL (90g/L);

5. Serum creatinine ≤ 1.5x the upper limit of normal (ULN) or creatinine clearance (CrCl)≥ 40 mL/min;

6. Bilirubin≤ 1.5x ULN;

7. Aspartate Aminotransferase (AST) ≤ 2.5x ULN or Alanine Aminotransferase (ALT) ≤ 2.5x ULN; patients with liver metastasis must be ≤5x ULN;

8. International normalized ratio (INR) ≤ 1.5, prothrombin time (PT) and activated partial thromboplastin time (APTT) ≤ 1.5 times ULN;

9. Urine protein < 2 +; if urinary protein ≥ 2 +, the 24-hour urine protein quantification must be ≤ 1g.

Exclusion Criteria:

1. Other diseases that may have influence on this study ( such as active infection, symptomatic myocardial infarction, angina pectoris, arrhythmia, etc.).

2. Patients who received systemic anti-tumor therapy and local treatment (radiotherapy, ablation and embolization) for gastric cancer within 1 month.

3. Patients who have active autoimmune diseases and need systemic immunosuppressive therapy.

4. Life expectancy < 6 months.

5. Patients with organ allografts.

6. Women who are pregnant or nursing/breastfeeding

7. Allergic to allogeneic protein.

8. 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).

9. For any other reasons, the patients are believed not suitable for participation in this study by investigators .