Clinical trial · Interventional
Immunotherapy for Colorectal Cancers Using CEA-Pulsed Dendritic Cells and Subsequent IL-2 Treatment
A Phase I/II Clinical Study of Immunotherapy for Advanced Colorectal Cancers Using CEA-Pulsed Dendritic Cells Mixed With Tetanus Toxoid and Subsequent IL-2 Treatment
NCT00154713CI-TRIAL-00000133unknownPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The specific aims of this study are as follows: 1. Primary endpoint: to evaluate the clinical responses of vaccinated patients. 2. Secondary endpoint: to evaluate the safety of this treatment and the immune responses against CEA before and after the treatment
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CEA pulsed dendritic cells | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- evaluate the clinical responses of vaccinated patients 6 weeks after the first injection
Secondary outcomes (1)
- measure
- evaluate the safety of this treatment and the immune responses against CEA before and after the treatment 6 weeks after the first injection
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Patients must have metastatic colorectal cancer. * Patients must have at least one measurable lesion. * Patients'serum level of CEA must be higher than 5 times of the normal value * Patients'disease must have failed chemotherapy with 5FU, CPT-11 or oxaliplatin. * Patients who are unsuitable or refuse chemotherapy will be considered eligible for this trial. * Patients'age must be 20 or greater. * Patients'estimated life expectancy is more than 3 months. * Patients must have adequate bone marrow function, defined as WBC \>= 3500/mm3, neutrophil \>= 1500/mm3, lymphocyte \>= 1,000/mm3, and platelet \>= 100,000/mm3. * Patients must have adequate liver and renal function, defined as serum alanine transaminase (ALT) and aspartate transaminase (AST) =\< 5 times normal, bilirubin =\< 1.5 times normal range, and creatinine =\< 2 times upper normal limit. * All patients should have documentation of negative result of penicillin test. * Women or men of reproductive potential may not participate unless they have agreed to use an effective contraceptive method. * All patients must be informed of the investigational nature of this study and must sign and give written informed consent. Exclusion Criteria: * Patients who have central nervous system metastasis except for those whose CNS disease has been treated with radiotherapy and/or surgery and has been stable for at least two weeks * Patients who have active acute or chronic infection (at the discretion of the investigator). * Pregnant or breast-nursing women * Patients who have active cardiac disease requiring therapy for failure, angina, arrythmia, or infarction within the preceding 6 months (exception: any patient whose cardiac failure is compensated on medications) * Patients who have asthma * Patients who have autoimmune disease such as inflammatory bowel disease, lupus erythematosus, ankylosing spondylitis, scleroderma, and multiple sclerosis * Patients who have serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator) * Patients who have other prior or concurrent malignancy except for in-situ-carcinoma of cervix or adequately treated basal cell carcinoma of skin. * Patients who received chemotherapy, steroid or biologic treatment within 4 weeks prior to enrollment
References
Publications (1)
- DERIVEDLiu KJ, Chao TY, Chang JY, Cheng AL, Ch'ang HJ, Kao WY, Wu YC, Yu WL, Chung TR, Whang-Peng J. A phase I clinical study of immunotherapy for advanced colorectal cancers using carcinoembryonic antigen-pulsed dendritic cells mixed with tetanus toxoid and subsequent IL-2 treatment. J Biomed Sci. 2016 Aug 24;23(1):64. doi: 10.1186/s12929-016-0279-7. PMID 27558635