NCT02280278

Brief Summary

We hypothesize through this randomized, prospective, single center adjuvant study, that cytokine-induced killer cell in patients with stage III colon cancer can improve survival in this patient population over control. Stage III colon cancer patients can benefit most from adjuvant chemotherapy, but the 5 year survival rate is still around 60%. We wish CIK cell therapy can improve the survival rate of stage III colon cancer patients.

Trial Health

55
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Trial Health Score

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

Enrollment
550

participants targeted

Target at P75+ for phase_3

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

October 29, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 31, 2014

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2019

Completed
Last Updated

November 5, 2014

Status Verified

November 1, 2014

Enrollment Period

5 years

First QC Date

October 29, 2014

Last Update Submit

November 3, 2014

Conditions

Stage III Colon Cancer

Keywords

colon cancercytokine-induced killer cell immunotherapy

Outcome Measures

Primary Outcomes (1)

  • Disease free survival

    3 years

Secondary Outcomes (2)

  • survival rate

    5 years

  • toxin-side effect

    1 year

Study Arms (2)

CIK group

EXPERIMENTAL

Stage III Colon Cancer patients after radical operation and adjuvant chemotherapy will receive 8 cycles of CIK therapy in this group.

Procedure: Radical surgeryDrug: Adjuvant chemotherapyBiological: Cytokine-induced killer cell immunotherapy

Control group

ACTIVE COMPARATOR

Stage III Colon Cancer patients will only receive radical operation and adjuvant chemotherapy.

Procedure: Radical surgeryDrug: Adjuvant chemotherapy

Interventions

Radical surgeryPROCEDURE
CIK groupControl group
Adjuvant chemotherapyDRUG
CIK groupControl group
Cytokine-induced killer cell immunotherapyBIOLOGICAL
CIK group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female outpatient of ≥ 18 years of age or ≥ country's legal age for adult consent
  • Stage III colon cancer
  • undergone complete resection of primary tumor
  • Completed standard adjuvant chemotherapy
  • within 120 days of completion of standard therapy
  • ECOG performancer status 0-2
  • Satisfactory haematological or biochemical functions (tests should be carried out within 8 weeks prior to randomisation): Results of clinical investigations carried out within 8 weeks prior to randomisation can be used in place of the required screening investigations. Patients with mild laboratory abnormalities can be included at the discretion by the site principal investigator, and after approval by ASCOLT Trial Management Group
  • ANC ≥ 1.0 x 109/L
  • Platelets ≥ 100 x 109/L
  • Creatinine clearance ≥ 30 mL/min
  • Total bilirubin ≤ 2.0 x the upper limit normal
  • AST \& ALT ≤ 5 x the upper limit normal
  • Completed the following investigations
  • Completed the following investigations

You may not qualify if:

  • HIV positive or other Immunodeficiency disease
  • recently use of high dose glucocorticoid
  • Uncontrolled hypertension (untreated systolic blood pressure \> 160 mmHg, or diastolic blood pressure \> 95 mmHg)
  • History of recent cancers (except for colorectal cancers, non-melanoma skin cancers, basal cell carcinomas, squamous cell carcinomas) in the past 5 years
  • Patient having known allergy to capecitabine or Oxaliplatin
  • Pregnant, lactating

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sun Yat-Sen University Cancer Center

Guagzhou, Guangdong, 510060, China

RECRUITING

MeSH Terms

Conditions

Colonic Neoplasms

Interventions

Chemotherapy, Adjuvant

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

Combined Modality TherapyTherapeuticsDrug Therapy

Study Officials

  • Xiao-Jun Wu, Prof.

    Sun Yat-sen University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiao-Jun Wu, Prof.

CONTACT

+86 20 87343456wuxj@sysucc.org.cn

De-Sen Wan, Prof.

CONTACT

+86 20 87343456wands@sysucc.org.cn

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 29, 2014

First Posted

October 31, 2014

Study Start

October 1, 2014

Primary Completion

October 1, 2019

Last Updated

November 5, 2014

Record last verified: 2014-11

Locations

CN(1)