Back to results

Cytokine-induced Killer Cell Immunotherapy for Surgical Resected Stage III Colorectal Cancer Patients After Chemotherapy

Primary Purpose

Stage III Colon Cancer

Status

Unknown status

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

Radical surgery

Adjuvant chemotherapy

Cytokine-induced killer cell immunotherapy

About this trial

This is an interventional treatment trial for Stage III Colon Cancer focused on measuring colon cancer, cytokine-induced killer cell immunotherapy

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

Sun Yat-Sen University Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

CIK group

Control group

Arm Description

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

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

Outcomes

Primary Outcome Measures

Disease free survival

Secondary Outcome Measures

survival rate

toxin-side effect

Toxin-side effect will be assessed by laboratory test, clinicians and questionary

Full Information

NCT ID

NCT02280278

First Posted

October 29, 2014

Last Updated

November 3, 2014

Sponsor

Sun Yat-sen University

1. Study Identification

Unique Protocol Identification Number

NCT02280278

Brief Title

Cytokine-induced Killer Cell Immunotherapy for Surgical Resected Stage III Colorectal Cancer Patients After Chemotherapy

Official Title

The Effectiveness and Safety of Adjuvant Cytokine-induced Killer Cell Immunotherapy for Stage III Colorectal Cancer Patients After Chemotherapy

Study Type

Interventional

2. Study Status

Record Verification Date

November 2014

Overall Recruitment Status

Unknown status

Study Start Date

October 2014 (undefined)

Primary Completion Date

October 2019 (Anticipated)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Sun Yat-sen University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stage III Colon Cancer

Keywords

colon cancer, cytokine-induced killer cell immunotherapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

550 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

CIK group

Arm Type

Experimental

Arm Description

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

Arm Title

Control group

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

Radical surgery

Intervention Type

Drug

Intervention Name(s)

Adjuvant chemotherapy

Intervention Type

Biological

Intervention Name(s)

Cytokine-induced killer cell immunotherapy

Primary Outcome Measure Information:

Title

Disease free survival

Time Frame

3 years

Secondary Outcome Measure Information:

Title

survival rate

Time Frame

5 years

Title

toxin-side effect

Description

Toxin-side effect will be assessed by laboratory test, clinicians and questionary

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Xiao-Jun Wu, Prof.

Phone

+86 20 87343456

wuxj@sysucc.org.cn

First Name & Middle Initial & Last Name or Official Title & Degree

De-Sen Wan, Prof.

Phone

+86 20 87343456

wands@sysucc.org.cn

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Xiao-Jun Wu, Prof.

Organizational Affiliation

Sun Yat-sen University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Sun Yat-Sen University Cancer Center

City

Guagzhou

State/Province

Guangdong

ZIP/Postal Code

510060

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Rong-Xin Zhang, Doc.

Phone

+86 20 87343456

zhangrx@sysucc.org.cn

First Name & Middle Initial & Last Name & Degree

Xiao-Shi Zhang, Doc.

Phone

+86 20 87343456

zhangxs@sysucc.org.cn

First Name & Middle Initial & Last Name & Degree

Xiao-Jun Wu, Prof.

First Name & Middle Initial & Last Name & Degree

Rong-Xin Zhang, Doc.

First Name & Middle Initial & Last Name & Degree

Zhi-Zhong Pan, Prof.

First Name & Middle Initial & Last Name & Degree

Xiao-Shi Zhang, Prof.

First Name & Middle Initial & Last Name & Degree

Jian-Chuan Xia, Prof.

First Name & Middle Initial & Last Name & Degree

Dan-Dan Li, Doc.

First Name & Middle Initial & Last Name & Degree

Gong Chen, Prof.

First Name & Middle Initial & Last Name & Degree

Zhen-Hai Lu, Prof.

First Name & Middle Initial & Last Name & Degree

Yu-Jing Fang, Prof.

First Name & Middle Initial & Last Name & Degree

Li-Heng Kong, Doc.

First Name & Middle Initial & Last Name & Degree

Jun-Zhong Lin, Doc.

12. IPD Sharing Statement

Learn more about this trial

Cytokine-induced Killer Cell Immunotherapy for Surgical Resected Stage III Colorectal Cancer Patients After Chemotherapy

We'll reach out to this number within 24 hrs