Clinical Study of DC-CIK Cells as a Post-remission Treatment for Malignant Tumors

• Status: Recruiting
• Trial end date: 2023-01-20
• Target enrollment: 0
• Participant gender: All

Summary

1. Screening stage

2. Evaluation of disease

3. Grouping of patients

4. Infusion of cells

5. Surveillance of adverse effect

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Li Yu
• Treatments: Decitabine

Criteria

Inclusion Criteria:

1. Male or female patients aged 18-70 years (including 18 and 70 years);

2. Pathological and histological examination confirmed a malignant solid tumor;

3. Patients with ECOG score <2, estimated survival time> 3 months.

4. Patients with solid tumors have cleared their lesions after treatment, and are unsuitable or unwilling to receive other anti-tumor treatments such as chemotherapy and radiotherapy;

5. Patients did not receive any anti-cancer treatment such as chemotherapy, radiotherapy, immunotherapy (such as immunosuppressive drugs) within 2-4 weeks before enrollment, and their previous treatment-related toxicities have recovered to <1 (hair loss) , Except for low-level toxicity such as peripheral neuritis);

6. The patient's venous channel is unobstructed, which can meet the needs of intravenous drip;

7. Patients voluntarily participate and sign informed consent, and follow the research treatment plan and visit plan.

Exclusion Criteria:

• 1. Patients use large doses of hormones (except for patients using inhaled hormones) within 1 week before enrollment; 2. People with severe autoimmune diseases, immunodeficiency diseases or severe allergies; 3. Patients treated with other cellular immune products (DC, T, NK, and CAR-T, etc.); 4. Patients have uncontrollable infections within 4 weeks before enrollment; 5. Active HBV DNA> 1000copy / mL / Hepatitis C virus (anti-HCV positive, HCV RNA positive), HIV positive, syphilis positive; 6. Patients participated in other clinical studies within 6 weeks before enrollment; 7. Patients with mental illness; 8. Patients with a substance abuse / addiction and medical, psychological or social conditions that may interfere with the study or influence the evaluation of the study results; 9. Alcohol dependence in patients; 10. Women who are pregnant (positive urine / blood pregnancy study) or breastfeeding; men or women with a pregnancy plan in the past year; patients cannot guarantee effective contraception during the study period 11. At the discretion of the investigator, the patient has other unsuitable conditions.