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

NCT ID: NCT03047525

Last Updated: 2017-02-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-20

Study Completion Date

2020-12-01

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.

Detailed Description

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Conditions

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Colorectal Cancer Renal Cell Carcinoma Nasopharyngeal Carcinoma Lung Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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control group

patients will just regularly chemotherapy

Group Type NO_INTERVENTION

No interventions assigned to this group

DC-CIK and CIK Immunotherapy

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

Group Type EXPERIMENTAL

Cytokine-induced Killer Cells

Intervention Type BIOLOGICAL

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

Interventions

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Cytokine-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

Intervention Type BIOLOGICAL

Other Intervention Names

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DC-CIK and CIK

Eligibility Criteria

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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.

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.)..
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Xiaoyi Huang

OTHER

Sponsor Role lead

Responsible Party

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Xiaoyi Huang

Director of The Heilongjiang Cancer Biotherapy Center

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Harbin Medical University Cancer Hospital

Harbin, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Xiaoyi Huang

Role: CONTACT

+8618745796786

Qi Li

Role: CONTACT

+8613936344890

Facility Contacts

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Yi X Huang

Role: primary

+8618745796786

Qi Li

Role: backup

+8613936344890

Other Identifiers

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HMU-2016-002

Identifier Type: -

Identifier Source: org_study_id

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