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

Phase 1

• Conditions: Colorectal Cancer; Nasopharyngeal Carcinoma; Lung Cancer; Renal Cell Carcinoma
• Interventions: Biological: Cytokine-induced Killer Cells

• Registration Number: NCT03047525
• Lead Sponsor: Xiaoyi Huang

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2017-02
• Study First Submitted: 2017-02-07
• Study First Submitted QC: 2017-02-08
• Last Update Submitted: 2017-02-08
• Study First Posted: 2017-02-09
• Last Update Posted: 2017-02-09
• Study Start: 2017-02-20
• Primary Completion: 2019-01-01
• Study Completion: 2020-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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.)..

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
DC-CIK and CIK Immunotherapy	Cytokine-induced Killer Cells	patients will receive chemotherapy with 4 cycles of DC-CIK treatment and 4 cycles of CIK treatment .

Primary Outcome Measures

Name	Time	Method
progression-free survival(PFS)	1 month

Trial Locations

Locations (1)

Harbin Medical University Cancer Hospital; 🇨🇳 Harbin, China