Clinical trial · Interventional
Study With Dendritic Cell Immunotherapy in Resected Hepatic Metastasis of Colorectal Carcinoma
Randomized Phase II Study With Dendritic Cell Immunotherapy in Patients With Resected Hepatic Metastasis of Colorectal Carcinoma
NCT01348256CI-TRIAL-00030015unknownPhase 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)
In this randomized multicentric phase II study, patients with colorectal carcinoma with resectable hepatic metastasis will be randomized to treatment with dendritic cells or to observation, following conventional treatment with surgery and chemotherapy.
Conditions
Conditions (2)
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 Carcinoma | Colorectal Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Hepatic Metastasis | Colorectal Neoplasm | PROBABILISTIC | 0.70 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dendritic cells vaccine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Observation
- description
- Observation after standard treatment
- type
- EXPERIMENTAL
- label
- Dendritic cells vaccine
- description
- Adjuvant treatment with dendritic cells vaccine after standard treatment
- interventionNames
- Drug: Dendritic cells vaccine
Primary outcomes (1)
- measure
- Progression Free survival
- timeFrame
- Progression free survival at 2 years
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age over 18 years. 2. Confirmed diagnosis of colorectal cancer with hepatic metastasis, amenable for surgical treatment. 3. Capacity of understanding and signing the informed consent and to undergo the study procedures 4. Availability of tumor tissue, for maturing dendritic cells 5. Adequate renal, hepatic and bone marrow function Exclusion Criteria: 1. Clinically relevant diseases or infections. 2. Concurrent participation in other clinical trial or administration or other antitumoral treatment 3. Concurrent cancer, with the exceptions allowed by the principal investigator (PI). 4. Pregnant or breast feeding women 5. Immunosuppressant treatment
References
Publications (1)
- DERIVEDRodriguez J, Castanon E, Perez-Gracia JL, Rodriguez I, Viudez A, Alfaro C, Onate C, Perez G, Rotellar F, Inoges S, Lopez-Diaz de Cerio A, Resano L, Ponz-Sarvise M, Rodriguez-Ruiz ME, Chopitea A, Vera R, Melero I. A randomized phase II clinical trial of dendritic cell vaccination following complete resection of colon cancer liver metastasis. J Immunother Cancer. 2018 Sep 29;6(1):96. doi: 10.1186/s40425-018-0405-z. PMID 30268156