NCT02202928

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P50-P75 for phase_2 colorectal-cancer

Timeline
Completed

Started Jul 2014

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2014

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

July 25, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 29, 2014

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

December 28, 2015

Status Verified

July 1, 2015

Enrollment Period

3.4 years

First QC Date

July 25, 2014

Last Update Submit

December 23, 2015

Conditions

Colorectal CancerNeoplasmsIntestinal NeoplasmsDigestive System NeoplasmsGastrointestinal Diseases

Keywords

Colorectal cancerDC-CIKAutologous tumor lysate

Outcome Measures

Primary Outcomes (1)

  • Progress-free survival

    3 years

Secondary Outcomes (3)

  • Overall survival

    3 years

  • Quality of life (QOL)

    3 Years

  • Phenotypic analysis of T cells

    1 year

Study Arms (2)

Chemo-radiotherapy

SHAM COMPARATOR

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

Radiation: RadiotherapyDrug: Chemotherapy

DC-CIK

EXPERIMENTAL

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

Biological: DC-CIKRadiation: RadiotherapyDrug: Chemotherapy

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.

DC-CIK
RadiotherapyRADIATION

45\~50 Gy in 25-28 fractions.

Chemo-radiotherapyDC-CIK
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.

Also known as: FOLFOX
Chemo-radiotherapyDC-CIK

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \~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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jingzhou Central Hospital Immunotherapy center

Jingzhou, Hubei, 434020, China

Location

MeSH Terms

Conditions

Colorectal NeoplasmsNeoplasmsIntestinal NeoplasmsDigestive System NeoplasmsGastrointestinal Diseases

Interventions

RadiotherapyDrug TherapyFolfox protocol

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsNeoplasms by SiteDigestive System DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Ke N Zhang, Professor

    Jingzhou Central Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 25, 2014

First Posted

July 29, 2014

Study Start

July 1, 2014

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

December 28, 2015

Record last verified: 2015-07

Locations

CN(1)