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

Phase 2

• Conditions: Colorectal Cancer; Neoplasms; Intestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases
• Interventions: Radiation: Radiotherapy; Biological: DC-CIK; Drug: Chemotherapy

• Registration Number: NCT02202928
• Lead Sponsor: Shenzhen Hornetcorn Bio-technology Company, LTD

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.

Study Timeline

• Study Start: 2014-07
• Study First Submitted: 2014-07-25
• Study First Submitted QC: 2014-07-25
• Study First Posted: 2014-07-29
• Status Verified: 2015-07
• Last Update Submitted: 2015-12-23
• Last Update Posted: 2015-12-28
• Primary Completion: 2017-12
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Chemo-radiotherapy	Radiotherapy	After accepting concurrent radiotherapy and chemotherapy according to NCCN guidelines, patients will just regularly follow up.
Chemo-radiotherapy	Chemotherapy	After accepting concurrent radiotherapy and chemotherapy according to NCCN guidelines, patients will just regularly follow up.
DC-CIK	DC-CIK	After accepting concurrent radiotherapy and chemotherapy according to NCCN guidelines, patients will receive 3 cycles of autologous tumor lysate pulsed DC-CIK treatment.
DC-CIK	Radiotherapy	After accepting concurrent radiotherapy and chemotherapy according to NCCN guidelines, patients will receive 3 cycles of autologous tumor lysate pulsed DC-CIK treatment.
DC-CIK	Chemotherapy	After accepting concurrent radiotherapy and chemotherapy according to NCCN guidelines, patients will receive 3 cycles of autologous tumor lysate pulsed DC-CIK treatment.

Primary Outcome Measures

Name	Time	Method
Progress-free survival	3 years

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Jingzhou Central Hospital Immunotherapy center; 🇨🇳 Jingzhou, Hubei, China