Trial · NCT06833866
Phase I Trial of 5-Fluorouracil (5FU) -Based Therapy in Combination With Hydroxytyrosol (HT) in Patients With Advanced or Metastatic Colorectal Cancer
NCT06833866, Phase 1, Recruiting, The Methodist Hospital Research Institute
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Phase I Trial of 5-Fluorouracil (5FU) -Based Therapy in Combination With Hydroxytyrosol (HT) in Patients With Advanced or Metastatic Colorectal Cancer. Trials, record NCT06833866. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06833866
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase I Trial of 5-Fluorouracil (5FU) -Based Therapy in Combination With Hydroxytyrosol (HT) in Patients With Advanced or Metastatic Colorectal Cancer
- NCT number
- NCT06833866
- Status
- Recruiting
- Phases
- Phase 1
- Enrollment
- 33 participants, estimated
- Lead sponsor
- The Methodist Hospital Research Institute
- Conditions
- Advanced or Metastatic CRC
- Interventions
- Hydroxytyrosol
- First posted
- 2025-02-19
- Last updated
- 2026-10-07
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Safety, Toxicity, and Pharmacokinetic/Pharmacodynamic (PK/PD) Profile of HT in Combination with FOLFIRI/FOLFOX + Biologics | Through study completion, up to 2 years | Evaluation of safety profile, toxicity, and PK/PD parameters in patients receiving HT with 5FU-based therapy according to NCI CTCAE v5.0. |
| Secondary | Progression-Free Survival (PFS) at 6 and 12 Months | 6 and 12 months post study drug initiation | Measurement of PFS at 6 months and 12 months, based on tumor assessment using RECIST v1.1 criteria. |
| Secondary | Objective Response Rate (ORR) According to RECIST v1.1 | Through study completion, up to 2 years | Proportion of patients achieving partial response (PR) or complete response (CR) as per RECIST v1.1. |
| Other | Changes in Health-Related Quality of Life (QoL) | Baseline, 6 months, and 12 months | Assessed using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30). |
| Other | Immune T-Cell Profiling in Blood and Tissue Samples | Baseline, 2 weeks after HT initiation, and up to 100 weeks (from baseline to disease progression) | Analysis of T-cell clusters in pretreatment tissue and blood and on-treatment blood (after 2 weeks on HT alone). Evaluation of CD4+, CD8+ T cells, and CD8+ T-cell:Treg ratio using multiplexed IF \& single-cell RNA sequencing (scRNA-seq). |
| Other | Assessment of Tissue Immune Cells | Baseline and post-treatment biopsy (up to 100 weeks, at disease progression or prior to surgery, if applicable) | Quantification of tissue immune cells using flow cytometry. |
| Other | Analysis of Regulatory Proteins and Plasma Cytokines | Baseline and post-treatment biopsy (up to 100 weeks, at disease progression or prior to surgery, if applicable) | Evaluation of regulatory proteins and plasma cytokines using a multiplexed protein array. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT06833866
GET https://conductscience.org/api/trials/v1/NCT06833866/registered