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

Shenzhen Hornetcorn Biotechnology

Status and phase: Unknown; Phase 2

Conditions: Intestinal Neoplasms; Gastrointestinal Diseases; Neoplasms; Digestive System Neoplasms; Colorectal Cancer

Treatments: Radiation: Radiotherapy; Biological: DC-CIK; Drug: Chemotherapy

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02202928

HYK-Colorectal Cancer

Details and patient eligibility

About

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).

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Chemo-radiotherapy

Sham Comparator group

Description:

After accepting concurrent radiotherapy and chemotherapy according to NCCN guidelines, patients will just regularly follow up.

Treatment:

Drug: Chemotherapy

Radiation: Radiotherapy

DC-CIK

Experimental group

Description:

After accepting concurrent radiotherapy and chemotherapy according to NCCN guidelines, patients will receive 3 cycles of autologous tumor lysate pulsed DC-CIK treatment.

Treatment:

Drug: Chemotherapy

Biological: DC-CIK

Radiation: Radiotherapy