Adoptive Cell Therapy Plus Chemotherapy and Radiation After Surgery in Treating Patients With Colorectal Cancer

Phase 2 Study of Autologous Tumor Lysate-pulsed DC-CIK Cell in Colorectal Cancer After Surgery

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02202928

Enrollment

Registered

2014-07-29

Start date

2014-07-31

Completion date

2017-12-31

Last updated

2015-12-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer, Neoplasms, Intestinal Neoplasms, Digestive System Neoplasms, Gastrointestinal Diseases

Keywords

Colorectal cancer, DC-CIK, Autologous tumor lysate

Brief summary

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

Detailed description

60 patients with stageⅠ\ Ⅲ CRC, who had received surgery and kept their tumor tissue, will be randomly divided into group A (receive DC-CIK treatment, chemotherapy and radiotherapy) or group B (just receive chemotherapy and radiotherapy), and the randomize ratio will be 1:1. Patients in group A will receive 3 cycles of autologous tumor lysate pulsed DC-CIK cells treatment (every 4 weeks) and 4 cycles chemo-radiotherapy. Patients in group B will receive only 4 cycles chemo-radiotherapy.

Interventions

BIOLOGICALDC-CIK

8×10\^9 autologous tumor lysate pulsed DC-CIK cells for each infusion, IV (in the vein) for four cycles, each cycle received four infusions with a 1 day interval.

RADIATIONRadiotherapy

45\ 50 Gy in 25-28 fractions.

DRUGChemotherapy

Oxaliplatin 85mg/m2 IV over 2 hours, day 1; Leucovorin 400mg/m2 IV over 2 hours, day 1; 5-FU 400mg/m2 IV bolus on day 1, then 1200mg/m2/day for 2 days IV continuous infusion; Repeat every 2 weeks.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

* 18\ 80 years old; * Histologically confirmed with colorectal cancer at stage Ⅰ\ Ⅲ; * Patients who can accept curative operations; * Patients who have a life expectancy of at least 3 months; * Eastern Cooperative Oncology Group (ECOG) performance status was 0 - 1.

Exclusion criteria

* Hemoglobin\<8.0 g/dL,Platelet count \<75 x 10\^9/L; ALT, AST, BUN and Cr more than normal limits on 3.0 times ; * Known or suspected allergy to the investigational agent or any agent given in association with this trial; * Pregnant or lactating patients; * Known history of Human Immunodeficiency Virus (HIV), Hepatitis C Virus (HCV) or TreponemaPallidun (TP) infection; * Patients who are suffering from serious autoimmune disease; * History of organ allograft; * Patients who had distant metastases; * Patients who had active infection; * Prior use of any anti-cancer treatment in 30 days; * Now or recently will join another experimental clinical study ; * Other situations that the researchers considered unsuitable for this study.

Design outcomes

Primary

Measure	Time frame
Progress-free survival	3 years

Secondary

Measure	Time frame	Description
Overall survival	3 years	—
Quality of life (QOL)	3 Years	—
Phenotypic analysis of T cells	1 year	The number of CD3+ (or CD8+ or CD4+ or CD56+) T cell

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026