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A single center single arm phase II cinical study of autologous cytokine induced killer cells (D-CIK cells) in the treatment of relapsed and refractory malignant solid tumors

A single center single arm phase II cinical study of autologous cytokine induced killer cells (D-CIK cells) in the treatment of relapsed and refractory malignant solid tumors

Status
Recruiting
Phases
Phase 2
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-OIC-17011679
Enrollment
Unknown
Registered
2017-06-16
Start date
2017-06-26
Completion date
Unknown
Last updated
2017-06-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung cancer, liver cancer, and breast cancer, ovarian cancer, renal clear cell carcinoma, malignant melanoma, nasopharyngeal carcinoma

Interventions

Autologous D-CIK cell therapy (test group):D-CIK cell therapy group

Sponsors

The First Affiliated Hospital of Guangzhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) after imaging, tissue and / or cytology in the diagnosis of lung cancer, breast cancer, ovarian cancer, liver cancer, renal cell carcinoma, tumor and nasopharyngeal malignant melanoma patients, routine treatment (surgery, chemotherapy and radiotherapy) and palliative treatment of patients with advanced; (2) at least one measurable objective tumor index (diagnosis by imaging, such as: CT, MRI test can measure the maximum diameters were larger than 1cm); (3) there was no history of other tumors (except for squamous cell carcinoma treated by surgery); (4) male or female, aged above the age of 18, under the age of 75 (including the age of 18 years old); (5) physical fitness: ECOG score of 0 or 1; (6) the expected survival time more than 3 months, and follow-up; (7) in the 7 days before the start of the treatment, blood routine, liver and kidney function, blood coagulation laboratory results meet the following criteria: white blood cell (WBC) = 3.5 * 109/L, platelet (PLT) = 80 * 10^9/L, neutrophil (ANC) = 1.5 * 10^9/L, hemoglobin (HGB) = 90g/L, aspartate aminotransferase (AST) < 2.5 * upper limit of normal (ULN) (liver metastasis < 5 * ULN), alanine aminotransferase (ALT) < 2.5 * ULN (liver metastasis < 5 * ULN), total bilirubin (TIBC) < 1.5 * ULN, serum creatinine (CR) < 1 * ULN, prothrombin time, partial thromboplastin time, plasma fibrinogen, thrombin time in the normal range; (8) female subjects must take effective contraceptive measures throughout the study period; (9) male patients should take effective contraceptive measures within 1 months after treatment and completion of chemotherapy; (10) Willing to obey this research project prohibitions and restrictions; (11) the subjects had signed informed consent, indicating that they understood the purpose of the study, the steps and contents of the study, and volunteered to participate in the study.

Exclusion criteria

Exclusion criteria: Subjects in any of the following circumstances could not participate in the study: (1) patients with clinical symptoms of brain metastasis (except after radiotherapy); (2) there is an active viral or bacterial infection and cannot be controlled with appropriate anti infective therapy. (3) known to be positive for HIV, syphilis, hepatitis B virus or hepatitis C virus infection; (4) suffering from mental illness or other conditions, such as uncontrollable heart disease or lung disease, diabetes, etc., can not meet the requirements of research and treatment and monitoring; (5) known to be allergic to any component of cultured CIK cells; (6) active rheumatic disease; (7) organ transplant recipients; (8) poor compliance; (9) pregnant and lactating women; Another 1) were enrolled in other clinical trials 2) the researchers believe that other causes are not appropriate for clinical trial.

Design outcomes

Primary

MeasureTime frame
Overall survival rate;

Secondary

MeasureTime frame
progression free survival;The total number of Complete remission and Partial remission (According to the response criteria in solid tumor(RECIST));Quality of life improvement;

Countries

China

Contacts

Public ContactHe Jianxing

The First Affiliated Hospital of Guangzhou Medical University

hejx@vip.163.com+86 020-83062337

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026