Status:
UNKNOWN
Clinical Study of DC-CIK Cells as a Post-remission Treatment for Malignant Tumors
Lead Sponsor:
Li Yu
Conditions:
Malignant Neoplasm
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief Summary
1. Screening stage 2. Evaluation of disease 3. Grouping of patients 4. Infusion of cells 5. Surveillance of adverse effect
Detailed Description
1. Screening stage：All patients must be confirmed by pathology priorily and reachead remission after surgery or chemo- or radiotherapy. All criteria patients must sign informed consent in advance. 2. ...
Eligibility Criteria
Inclusion
- Male or female patients aged 18-70 years (including 18 and 70 years);
- Pathological and histological examination confirmed a malignant solid tumor;
- Patients with ECOG score \<2, estimated survival time\> 3 months.
- 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;
- 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);
- The patient's venous channel is unobstructed, which can meet the needs of intravenous drip;
- Patients voluntarily participate and sign informed consent, and follow the research treatment plan and visit plan.
Exclusion
- 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.
Key Trial Info
Start Date :
January 21 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 20 2023
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT04292769
Start Date
January 21 2020
End Date
January 20 2023
Last Update
March 3 2020
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Shenzhen university general hospital
Shenzhen, China, 518000