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

NCT04292769 | Unknown Phase 3 DMC

• 1 other identifier: ONCO-CIK-001
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

1. 1.Screening stage
2. 2.Evaluation of disease
3. 3.Grouping of patients
4. 4.Infusion of cells
5. 5.Surveillance of adverse effect

Conditions

Malignant Neoplasm

Keywords

Decitabine; dendritic cell-cytokine induced killer

Outcome Measures

Primary Outcomes (2)

• OS

  overall survival rate

  up to 2 years

• PFS

  progression free survival

  up to 2 years

Secondary Outcomes (1)

• objective response rate

  up to 2 years

Study Arms (2)

Decitabine combined with DC-CIK

EXPERIMENTAL

Test group: decitabine combined with autologous DC-CIK cells infusion: decitabine 10mg / d, intravenous administration of d-5 to d-1, autologous DC-CIK cells infusion: first course: d1-d3 The second course: d14-d16; the total number of cells is about 5-10 × 109; IL-2: 200,000 IU / d subcutaneous injection, the first course: d0-d4, the second course: d13-d17, every 2 weeks 1 course of treatment, 2 courses in total.

Drug: Decitabine; Biological: DC-CIK

DC-CIK

ACTIVE COMPARATOR

Control group: autologous DC-CIK cell infusion: the first course: d1-d3, the second course: d14-d16; the total number of cells is about 5-10 × 109; One course: d0-d4, the second course: d13-d17, 1 course every 2 weeks, a total of 2 courses.

Biological: DC-CIK

Interventions

Decitabine DRUG

Decitabine 10mg / d, intravenous administration d-5 ～ d-1

Decitabine combined with DC-CIK

DC-CIK BIOLOGICAL

Autologous DC-CIK cell infusion: the first course: d1-d3, the second course: d14-d16; the total number of cells is about 5-10 × 109;

DC-CIK; Decitabine combined with DC-CIK

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \. 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.

Sponsors & Collaborators

• Li Yu: lead

Study Sites (1)

Shenzhen university general hospital

Shenzhen, 518000, China

RECRUITING

MeSH Terms

Conditions

Neoplasms

Interventions

Decitabine

Intervention Hierarchy (Ancestors)

Azacitidine; Aza Compounds; Organic Chemicals; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 24, 2020
• First Posted: March 3, 2020
• Study Start: January 21, 2020
• Primary Completion: January 20, 2023
• Study Completion: January 20, 2023
• Last Updated: March 3, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)