Study of DC-CTL Combined With CIK for Advanced Solid Tumor

Study Overview
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Brief Summary
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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.

Official Title
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The Opening and Negative Controlled Clinical Study of Autologous Multiple Targets DC-CTL Combined With CIK for Advanced Solid Tumor

Conditions
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Colorectal Cancer, Renal Cell Carcinoma, Nasopharyngeal Carcinoma, Lung Cancer

Intervention / Treatment
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* Biological: Cytokine-induced Killer Cells


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with treatment-refractory advanced colorectal cancer can not accept operation . Age 18 to 75 years.Eastern Cooperative Oncology Group (ECOG) score ≤ 2 points, estimate survival > 3 months; 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; Without any other malignant disease; With more than one scalable lesions Patients Voluntary attempt, and informed consent. 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: Patients who do not conform to the inclusion criteria;; Patients with uncontrolled infection; underlying disease that was severe or life-threatening(such as uncontrolled brain metastasis ); Patients who were pregnant or lactating; ECOG perform status ≥ 2; Other situations that the researchers considered unsuitable for this study (such as mental illness, drug abuse, etc.)..

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: control group<br>patients will just regularly chemotherapy | |
| Experimental: DC-CIK and CIK Immunotherapy<br>patients will receive chemotherapy with 4 cycles of DC-CIK treatment and 4 cycles of CIK treatment . | Biological: Cytokine-induced Killer Cells<br>* 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<br>* Other names: DC-CIK and CIK;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| progression-free survival(PFS) |  | 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cytokine-induced killer cell, dendritic and cytokine-induced killer cells