Trial · NCT07011576
A Study of Fruquintinib Plus FOLFIRI as Second-Line Treatment for Participants With Metastatic Colorectal Cancer (FRUITFUL)
NCT07011576, Phase 2, Recruiting, SCRI Development Innovations, LLC
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study of Fruquintinib Plus FOLFIRI as Second-Line Treatment for Participants With Metastatic Colorectal Cancer (FRUITFUL). Trials, record NCT07011576. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07011576
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Fruquintinib Plus FOLFIRI as Second-Line Treatment for Participants With Metastatic Colorectal Cancer (FRUITFUL)
- NCT number
- NCT07011576
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 60 participants, estimated
- Lead sponsor
- SCRI Development Innovations, LLC
- Conditions
- Colon Cancer, Rectal Cancer, Colorectal Cancer, Colorectal Cancer (CRC)
- Interventions
- fruquintinib, FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin)
- First posted
- 2025-06-09
- Last updated
- 2026-06-12
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-Free Survival (PFS) rate at 6 months | Every 2 cycles from cycle 1 day 1, until disease progression or death, up to 2 years. Each cycle is 28 days. | Progression-Free Survival (PFS) rate at 6 months, defined as the percentage of participants at 6 months who have not experienced disease progression as defined by the RECIST Version 1.1 criteria or death on study. Participants who are alive and free from disease progression will be censored at the date of last tumor assessment. |
| Secondary | Overall Response Rate (ORR) | Every 2 cycles from cycle 1 day 1, until disease progression or death, up to 2 years. Each cycle is 28 days. | Objective Response Rate (ORR), defined as the proportion of participants with confirmed CR or PR (i.e., 2 CRs or PRs at least 4 weeks apart) according to the RECIST Version 1.1. |
| Secondary | Duration of response (DoR) | Every 2 cycles from cycle 1 day 1, until disease progression or death, up to 2 years. Each cycle is 28 days. | Duration of Response (DoR), defined as the duration from the first documented response to the date of first documented PD or death due to any cause. In case a participant does not experience PD or death, DoR is censored at the date of last adequate tumor assessment (defined as an assessment of CR, PR, or SD). DoR analysis will include only responders (PR or better). |
| Secondary | Disease control response rate (DCR) | Every 2 cycles from cycle 1 day 1, until disease progression or death, up to 2 years. Each cycle is 28 days. | Disease Control Response Rate (DCR), defined as the proportion of participants with a best overall response of CR, PR, or SD. |
| Secondary | Number of participants with treatment emergent adverse events | Every 28 day cycle, from signed informed consent to 30 days after treatment discontinuation up to 1 year. | Using CTCAE V5.0 |
| Secondary | Overall Survival (OS) | From cycle 1 day 1 up to 2 years | Overall Survival (OS), defined as the time from the first day of study drug administration (Day 1) to death. Participants who are alive will be censored at the date of last known date alive. Each cycle is 28 days. |
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/NCT07011576
GET https://conductscience.org/api/trials/v1/NCT07011576/registered