Colorectal Cancer, Renal Cell Carcinoma, Nasopharyngeal Carcinoma, Lung Cancer
Conditions
Keywords
cytokine-induced killer cell, dendritic and cytokine-induced killer cells
Brief summary
Background: Combinations of Dendritic and Cytokine-induced Killer Cells (DC-CIK) and Cytokine-induced Killer Cells (CIK) treatment may enhance the immune response and stop cancer cells from growing. The investigators suppose that DC-CIK combined with CIK treatment will improve the prognosis of advanced solid tumors. Objective: Phase II clinical trial to investigate the efficacy of concurrent chemotherapy with DC-CIK and CIK treatment in patients with treatment-refractory solid tumors. Study treatment: Patients in group A will receive 4 cycles of CIK treatments and 4 cycles of DC-CIK treatments within 8 months. Patients in group B will have no immunotherapy . chemotherapy are available in both groups.
Interventions
BIOLOGICALCytokine-induced Killer Cells
Concurrent of chemotherapy plus 4 cycles of Dendritic and Cytokine-induced Killer Cells(DC-CIK) treatment and 4 cycles of Cytokine-induced Killer Cells(CIK) treatment
Sponsors
Xiaoyi Huang
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Patients with treatment-refractory advanced colorectal cancer can not accept operation . 2. Age 18 to 75 years.Eastern Cooperative Oncology Group (ECOG) score ≤ 2 points, estimate survival \> 3 months; 3. Blood White Blood Cell(WBC)≥ 4×109/L, Hb ≥ 100g/L, Platelet Count(PLT)≥ 80×109/L; Alanine aminotransferase(ALT) and aspartate aminotransferase(AST)≤ 2 times of normal upper value; Serum Cr ≤ 2 normal upper value; 4. Without any other malignant disease; 5. With more than one scalable lesions 6. Patients Voluntary attempt, and informed consent. 7. Women of child-bearing potential must have a negative pregnancy test because of the potentially dangerous effects of the preparative chemotherapy on the fetus.
Exclusion criteria
1. Patients who do not conform to the inclusion criteria;; 2. Patients with uncontrolled infection; underlying disease that was severe or life-threatening(such as uncontrolled brain metastasis ); Patients who were pregnant or lactating; 3. ECOG perform status ≥ 2; 4. Other situations that the researchers considered unsuitable for this study (such as mental illness, drug abuse, etc.)..
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression-free survival(PFS) | 1 month |
Countries
China
Contacts
Primary ContactXiaoyi Huang
Backup ContactQi Li
Outcome results
None listed