DC-CIK Immunotherapy Plus Chemotherapy vs Chemotherapy Alone in the Adjuvant Treatment of Stage III Colorectal Cancer
Randomized Controlled Trial Comparing DC-CIK Immunotherapy Combined With Adjuvant Chemotherapy and Adjuvant Chemotherapy Alone in Stage III Colorectal Cancer.
1 other identifier
interventional
100
0 countries
N/A
Brief Summary
Stage III colorectal cancer constitutes more than half of the colorectal patients, and the prognosis does not improve much recently although varies of adjuvant drugs have been tried. DC-CIK immunotherapy has been proved to improve survival in cancer patients, but its role in stage III colorectal cancer patients stains unclear. The investigators study will focus on the efficacy and safety of DC-CIK immunotherapy plus chemotherapy in the adjuvant treatment of stage III colorectal cancer, compared with chemotherapy alone.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 colorectal-cancer
Started Aug 2015
Typical duration for phase_2 colorectal-cancer
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
First Submitted
Initial submission to the registry
April 9, 2015
CompletedFirst Posted
Study publicly available on registry
April 14, 2015
CompletedStudy Start
First participant enrolled
August 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2020
CompletedApril 14, 2015
April 1, 2015
1.9 years
April 9, 2015
April 13, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Disease free survival
2 years
Secondary Outcomes (2)
Overall survival
2 years
Side Effect
6 month
Study Arms (2)
DC-CIK Immunotherapy Plus Chemotherapy
EXPERIMENTALStage III Colon Cancer patients after radical operation and adjuvant chemotherapy will receive 12 cycles of DC-CIK therapy in this group
Chemotherapy Alone
ACTIVE COMPARATORStage III Colon Cancer patients after radical operation and adjuvant chemotherapy alone.
Interventions
Eligibility Criteria
You may qualify if:
- Stage III colon cancer
- Undergone complete resection of primary tumor
- Completed standard adjuvant chemotherapy
- ECOG performancer status 0-2
- Adequate hematologic, hepatic and renal functions
You may not qualify if:
- HIV positive or other Immunodeficiency disease
- Uncontrolled hypertension
- History of recent cancers in the past 5 years
- Patients with previous or concurrent malignancy or any anti-cancer therapy
- Patients who were allergic to platinum drugs or fluorouracil
- Pregnant patients
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 9, 2015
First Posted
April 14, 2015
Study Start
August 1, 2015
Primary Completion
July 1, 2017
Study Completion
July 1, 2020
Last Updated
April 14, 2015
Record last verified: 2015-04