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Study of DC-CIK to Treat Colorectal Cancer

G

Guangxi Medical University

Status and phase

Unknown
Phase 2

Conditions

Colorectal Cancer

Treatments

Biological: dendritic and cytokine-induced killer cells

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy of dendritic and cytokine-induced killer cells (DC-CIK) for colorectal cancer (CRC).

Full description

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.

Enrollment

60 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

60 participants in 2 patient groups

B
No Intervention group
Description:
After neoadjuvant and (or) adjuvant chemotherapy or (and) radiotherapy according to NCCN guidelines, patients will only regularly follow up.
A
Experimental group
Description:
After neoadjuvant and (or) adjuvant chemotherapy or (and) radiotherapy according to NCCN guidelines, patients will receive 2-3 cycles of Dendritic and Cytokine-induced Killer Cells (DC-CIK) treatment (every 4 weeks).
Treatment:
Biological: dendritic and cytokine-induced killer cells

Trial contacts and locations

1

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Central trial contact

Hanfeng Liu

Data sourced from clinicaltrials.gov

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