Back to results

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

Primary Purpose

Colorectal Cancer, Renal Cell Carcinoma, Nasopharyngeal Carcinoma

Status

Unknown status

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

Cytokine-induced Killer Cells

About this trial

This is an interventional treatment trial for Colorectal Cancer focused on measuring cytokine-induced killer cell, dendritic and cytokine-induced killer cells

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.)..

Sites / Locations

Harbin Medical University Cancer HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

control group

DC-CIK and CIK Immunotherapy

Arm Description

patients will just regularly chemotherapy

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

Outcomes

Primary Outcome Measures

progression-free survival(PFS)

Secondary Outcome Measures

Full Information

NCT ID

NCT03047525

First Posted

February 7, 2017

Last Updated

February 8, 2017

Sponsor

Xiaoyi Huang

1. Study Identification

Unique Protocol Identification Number

NCT03047525

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2017

Overall Recruitment Status

Unknown status

Study Start Date

February 20, 2017 (Anticipated)

Primary Completion Date

January 1, 2019 (Anticipated)

Study Completion Date

December 1, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Xiaoyi Huang

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

cytokine-induced killer cell, dendritic and cytokine-induced killer cells

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

control group

Arm Type

No Intervention

Arm Description

patients will just regularly chemotherapy

Arm Title

DC-CIK and CIK Immunotherapy

Arm Type

Experimental

Arm Description

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

Intervention Type

Biological

Intervention Name(s)

Cytokine-induced Killer Cells

Other Intervention Name(s)

DC-CIK and CIK

Intervention Description

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

Primary Outcome Measure Information:

Title

progression-free survival(PFS)

Time Frame

1 month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.)..

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Xiaoyi Huang

Phone

+8618745796786

First Name & Middle Initial & Last Name or Official Title & Degree

Qi Li

Phone

+8613936344890

Facility Information:

Facility Name

Harbin Medical University Cancer Hospital

City

Harbin

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yi X Huang

Phone

+8618745796786

First Name & Middle Initial & Last Name & Degree

Qi Li

Phone

+8613936344890

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

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

We'll reach out to this number within 24 hrs