Stage III Colon Cancer
Conditions
Keywords
colon cancer, cytokine-induced killer cell immunotherapy
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.
Interventions
PROCEDURERadical surgery
DRUGAdjuvant chemotherapy
BIOLOGICALCytokine-induced killer cell immunotherapy
Sponsors
Sun Yat-sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease free survival | 3 years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| survival rate | 5 years | — |
| toxin-side effect | 1 year | Toxin-side effect will be assessed by laboratory test, clinicians and questionary |
Countries
China
Contacts
Primary ContactXiao-Jun Wu, Prof.
Backup ContactDe-Sen Wan, Prof.
Outcome results
None listed