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

Xiaoyi Huang

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Nasopharyngeal Carcinoma; Lung Cancer; Renal Cell Carcinoma; Colorectal Cancer

Treatments: Biological: Cytokine-induced Killer Cells

Study type: Interventional

Funder types: Other

Identifiers

NCT03047525

HMU-2016-002

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.)..

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

control group

No Intervention group

Description:

patients will just regularly chemotherapy

DC-CIK and CIK Immunotherapy

Experimental group

Description:

patients will receive chemotherapy with 4 cycles of DC-CIK treatment and 4 cycles of CIK treatment .

Treatment:

Biological: Cytokine-induced Killer Cells