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Phase Ⅱ Study of Dendritic and Cytokine-induced Killer Cells (DC-CIK) Treatment in Patients With Stage Ⅲ Colorectal Cancer


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Colorectal Cancer

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Trial Information

Phase Ⅱ Study of Dendritic and Cytokine-induced Killer Cells (DC-CIK) Treatment in Patients With Stage Ⅲ Colorectal Cancer


60 patients with stage Ⅲ CRC, who had received neoadjuvant and (or) adjuvant chemotherapy or
(and) radiotherapy according to NCCN guidelines, and got complete response (CR), will be
randomly divided into group A (receive DC-CIK treatment) or group B (just regularly follow
up), and the randomize ratio will be 1:1. Patients in group A will receive 2-3 cycles of
DC-CIK cells treatment (every 4 weeks). Patients in group B will have no anti-tumor therapy.


Inclusion Criteria:



1. Male or female patients ≥ 18 years of age;

2. CRC with histological diagnose, and had received neoadjuvant and (or) adjuvant
chemotherapy or (and) radiotherapy and got complete response (CR) with imaging;

3. Patients who have a life expectancy of at least 3 months;

4. Eastern Cooperative Oncology Group (ECOG) performance status was 0 - 1;

5. The bone marrow functioned normally (WBC > 4.0×109/L, Hb > 120 g/L, PLT > 100×109/L);

6. The ECG results were normal, and the liver and kidney were functional.

Exclusion Criteria:

1. Patients who had distant metastases;

2. Patients with uncontrolled infection; underlying disease that was severe or
life-threatening;

3. Patients who were pregnant or lactating;

4. ECOG perform status ≥ 2;

5. Patients who are suffering from auto immune diseases or patients who need to accept
glucocorticoid treatment.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival (PFS)

Outcome Time Frame:

5 years

Safety Issue:

No

Authority:

China: Ministry of Health

Study ID:

CRC-01

NCT ID:

NCT01839539

Start Date:

March 2013

Completion Date:

March 2018

Related Keywords:

  • Colorectal Cancer
  • colorectal cancer
  • DC-CIK
  • CRC
  • Colorectal Neoplasms

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