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

Phase 2UnknownNCT02202928

Shenzhen Hornetcorn Bio-technology Company, LTD60 enrolled

Overview

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).

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Colorectal Cancer Neoplasms Intestinal Neoplasms Digestive System Neoplasms Gastrointestinal Diseases

Interventions

DC-CIKBIOLOGICAL

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.

RadiotherapyRADIATION

45\~50 Gy in 25-28 fractions.

ChemotherapyDRUG

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (1)

Jingzhou Central Hospital Immunotherapy center

Jingzhou, Hubei, China

Outcomes

Primary Outcomes

Progress-free survival

Time frame: 3 years

Secondary Outcomes

Overall survival

Time frame: 3 years

Quality of life (QOL)

Time frame: 3 Years

Phenotypic analysis of T cells

The number of CD3+ (or CD8+ or CD4+ or CD56+) T cell

Time frame: 1 year

Data from ClinicalTrials.gov

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