Trial · NCT07042685
Trial of 5-Fluorouracil (5FU)-Based Therapy in Combination With Fruquintinib in Patients With Locally Advanced Unresectable or Metastatic Colorectal Cancer
NCT07042685, Phase 2, Recruiting, The Methodist Hospital Research Institute
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Trial of 5-Fluorouracil (5FU)-Based Therapy in Combination With Fruquintinib in Patients With Locally Advanced Unresectable or Metastatic Colorectal Cancer. Trials, record NCT07042685. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07042685
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Trial of 5-Fluorouracil (5FU)-Based Therapy in Combination With Fruquintinib in Patients With Locally Advanced Unresectable or Metastatic Colorectal Cancer
- NCT number
- NCT07042685
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 50 participants, estimated
- Lead sponsor
- The Methodist Hospital Research Institute
- Conditions
- Metastatic Colorectal Cancer (CRC)
- Interventions
- Fruquintinib Combined With Chemotherapy
- First posted
- 2025-06-29
- Last updated
- 2026-04-09
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time to Progression of 5FU in combination with fruquintinib in first-line metastatic colorectal cancer patients | From date of initial treatment until progression, unacceptable toxicity, treating physician's discretion, or patient withdraws, whichever comes first, assessed up to 24 months. | To assess the time to progression (TTP) of patients with locally advanced unresectable or metastatic colorectal cancer (mCRC) treated with 5-Fluorouracil (5FU)-based therapy in combination with fruquintinib, according to RECIST v1.1 criteria. |
| Secondary | Incidence of toxicity of 5FU in combination with fruquintinib in first-line metastatic colorectal cancer patients | From date of initial treatment until progression, unacceptable toxicity, treating physician's discretion, or patient withdraws from the study, whichever came first, assessed up to 13 months. | To assess the safety profile, toxicity (all grades of adverse event rates) of 5-Fluorouracil (5FU)-based therapy in combination with fruquintinib in patients with locally advanced unresectable or metastatic colorectal cancer (mCRC) according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0. |
| Secondary | Duration of the response of 5FU in combination with fruquintinib in first-line metastatic colorectal cancer patients | From date of initial treatment until progression, unacceptable toxicity, treating physician's discretion, or patient withdraws, whichever comes first, assessed up to 24 months. | To evaluate the duration of the response of 5-Fluorouracil (5FU)-based therapy in combination with fruquintinib in the first-line setting for locally advanced unresectable or metastatic colorectal cancer (mCRC) patients from onset of response to progression or death, whichever occurs earlier according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria and investigator's tumor assessment. |
| Other | Overall Survival rate of first-line metastatic colorectal cancer patients with 5FU in combination with fruquintinib | From date of initial treatment, 6 and 12 months, assessed up to 24 months until death. | To evaluate the overall survival (OS) rate of patients with locally advanced unresectable or metastatic colorectal cancer (mCRC) treated with 5-Fluorouracil (5FU)-based therapy in combination with fruquintinib at 6 and 12 months. |
| Other | Overall Response Rate of first-line metastatic colorectal cancer patients with 5FU in combination with fruquintinib | From date of initial treatment until progression, unacceptable toxicity, treating physician's discretion, or patient withdraws, whichever comes first, assessed up to 24 months. | To evaluate the overall response rate (ORR), disease control rate (DCR) and progression-free survival (PFS) of patients with locally advanced unresectable or metastatic colorectal cancer (mCRC) treated with 5-Fluorouracil (5FU)-based therapy in combination with fruquintinib at 6 and 12 months. |
| Other | Changes in health-related quality of life for first-line metastatic colorectal cancer patients with 5FU in combination with fruquintinib | From baseline to months 6 and 12 | Changes in health-related quality of life from baseline to months 6 and 12, as assessed by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). The EORTC QLQ-C30 scores range from 0 to 100. For global health status/quality of life and functional scales (e.g., physical, role, emotional, cognitive, social), higher scores indicate better outcomes (improved quality of life or functioning). For symptom scales/items (e.g., fatigue, pain, nausea/vomiting), higher scores indicate worse outcomes (more severe symptoms). |
| Other | Time to treatment failure of 5FU in combination with fruquintinib in first-line patients with metastatic colorectal cancer | From date of initial treatment until progression, unacceptable toxicity, treating physician's discretion, or patient withdraws from the study, whichever came first, assessed up to 24 months. | The number of months from beginning of treatment to the time of progression of patients on 5-Fluorouracil (5FU)-based therapy in combination with fruquintinib for patients with locally advanced unresectable or metastatic colorectal cancer (mCRC). |
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.
Papers16
The papers the trial lists on ClinicalTrials.gov.
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/NCT07042685
GET https://conductscience.org/api/trials/v1/NCT07042685/registered