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

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03047525
• Other study ID #: HMU-2016-002
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: February 7, 2017
• Last updated: February 8, 2017
• Start date: February 20, 2017
• Est. completion date: December 1, 2020

Study information

• Verified date: February 2017
• Source: Harbin Medical University
• Contact: Xiaoyi Huang
• Phone: +8618745796786
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 1, 2020
• Est. primary completion date: January 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.)..

Related Conditions & MeSH terms

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

Intervention

Biological:
• 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

Locations

Country	Name	City	State
China	Harbin Medical University Cancer Hospital	Harbin

Sponsors (1)

Lead Sponsor	Collaborator
Xiaoyi Huang

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	progression-free survival(PFS)		1 month