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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.

Status
UNKNOWN
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02415699
Enrollment
100
Registered
2015-04-14
Start date
2015-08-31
Completion date
2020-07-31
Last updated
2015-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer

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.

Interventions

DRUGFluorouracil
DRUGOxaliplatin
DRUGLeucovorin
BIOLOGICALDC-CIK

Sponsors

Sixth Affiliated Hospital, Sun Yat-sen University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frame
Disease free survival2 years

Secondary

MeasureTime frame
Overall survival2 years
Side Effect6 month

Contacts

Primary ContactXiaojian Wu, MD, PHD
sumswxj@126.com020-38254009

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026