Colorectal Neoplasms Clinical Trial
Official title:
Randomized Phase II Trial in Patients With Progressive Stage IV Colorectal Cancer to Two Lines of Chemotherapy, in Order to Compare the Best Supportive Treatment Versus Treatment With Dendritic Cells Plus the Best Supportive Treatment
The different alternatives used since 1996 to treat metastatic colorectal cancer (MCRC) have increased the mean survival of these patients. This outstanding advance is due to the extended indications for resection of hepatic metastases and to the use of new chemotherapeutic drugs (fluoropyrimidine, irinotecan and oxaliplatin) and monoclonal antibodies (bevacizumab, cetuximab and panitumumab). However, none of these treatments is curative and the majority of patients are overwhelmed by the illness. The first line of treatment for MCRC is FOLFOX and the second, irinotecan plus cetuximab for patients with wild type KRAS gene (60%) with a 30% responses, and bevacizumab plus irinotecan with a 5-10% of responses, in patients with mutated KRAS (40%). A treatment with autologous dendritic cells (DCs) pulsed with autologous tumour antigens is proposed as a third line of therapy. A randomized phase II trial would be performed, by selecting two groups of patients, one of them would be treated with the best supportive treatment and the other with DCs plus the best supportive treatment. The aim of the study would be to analyze the outcome after 4 months of treatment. In patients treated with DCs, IFN-γ spot forming cells and proliferative responses would be determined pre and post treatment in lymphocytes stimulated with autologous DCs pulsed with autologous tumour antigens. Pre and post treatment serum levels of IFN-γ, TNF-α, TGF-β e IL-12, would also be measured.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT04552093 -
Hepatic Arterial Infusion Pump Chemotherapy Combined With Systemic Chemotherapy (PUMP-IT)
|
Phase 2/Phase 3 | |
| Completed |
NCT04192565 -
A Prospective Investigation of the ColubrisMX ELS System
|
N/A | |
| Completed |
NCT05178745 -
A Prospective Observational Cohort Study Evaluating Resection Rate in Patients With Metastatic Colorectal Cancer Treated With Aflibercept in Combination With FOLFIRI - Observatoire résection
|
||
| Recruiting |
NCT03561350 -
Detect Microsatellite Instability Status in Blood Sample of Advanced Colorectal Cancer Patients by Next-Generation Sequencing
|
||
| Recruiting |
NCT06128798 -
Effect of Preoperative Immunonutrition Versus Standard Oral Nutrition in Patient Undergoing Colorectal Surgery.
|
N/A | |
| Recruiting |
NCT03602677 -
Indocyanine Green Fluorescence Imaging in Prevention of Colorectal Anastomotic Leakage
|
N/A | |
| Completed |
NCT03631407 -
Safety and Efficacy of Vicriviroc (MK-7690) in Combination With Pembrolizumab (MK-3475) in Participants With Advanced/Metastatic Microsatellite Stable (MSS) Colorectal Cancer (CRC) (MK-7690-046)
|
Phase 2 | |
| Withdrawn |
NCT04192929 -
Chromoendoscopy or Narrow Band Imaging (NBI) for Improving Adenoma Detection in Colonoscopy
|
N/A | |
| Recruiting |
NCT03042091 -
Neomycin and Metronidazole Hydrochloride With or Without Polyethylene Glycol in Reducing Infection in Patients Undergoing Elective Colorectal Surgery
|
Early Phase 1 | |
| Completed |
NCT02889679 -
Underwater Resection of Non-pedunculated Colorectal Lesions
|
N/A | |
| Terminated |
NCT02842580 -
De-escalation Chemotherapies Versus Escalation in Non Pre-treated Unresectable Patients With Metastatic Colorectal Cancer
|
Phase 2 | |
| Completed |
NCT02564835 -
Effects of Yoga on Cognitive and Immune Function in Colorectal Cancer
|
N/A | |
| Completed |
NCT02503696 -
Sample Collection Study to Evaluate DNA Markers in Subjects With Inflammatory Bowel Disease (IBD)
|
N/A | |
| Completed |
NCT02149108 -
Nintedanib (BIBF 1120) vs Placebo in Refractory Metastatic Colorectal Cancer (LUME-Colon 1)
|
Phase 3 | |
| Completed |
NCT02599103 -
The Effects of Various Cooking Oils on Health Related Biomarkers in Healthy Subjects
|
N/A | |
| Completed |
NCT01669109 -
Hatha Yoga for Patients With Colorectal Cancer
|
N/A | |
| Completed |
NCT01719926 -
Phase I Platinum Based Chemotherapy Plus Indomethacin
|
Phase 1 | |
| Recruiting |
NCT01428752 -
Study of Prevalence of Colorectal Adenoma in 30- to 49-year-old Subjects With a Family History of Colorectal Cancer
|
N/A | |
| Completed |
NCT01978717 -
General Anesthesia Combined With Epidural Anesthesia Mitigates the Surgical Stress-related Immunosuppression in Patients With Colorectal Cancer
|
N/A | |
| Completed |
NCT01877018 -
Colorectal Cancer Screening in Primary Care
|
N/A |