Trial · NCT06992258
A Randomized Phase 2 Trial of Fruquintinib and TAS-102 as Compared to Fruquintinib in Patients With Refractory Advanced/Metastatic Colorectal Cancer
NCT06992258, Phase 2, Recruiting, Criterium, Inc.
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. A Randomized Phase 2 Trial of Fruquintinib and TAS-102 as Compared to Fruquintinib in Patients With Refractory Advanced/Metastatic Colorectal Cancer. Trials, record NCT06992258. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06992258
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Randomized Phase 2 Trial of Fruquintinib and TAS-102 as Compared to Fruquintinib in Patients With Refractory Advanced/Metastatic Colorectal Cancer
- NCT number
- NCT06992258
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 120 participants, estimated
- Lead sponsor
- Criterium, Inc.
- Conditions
- Colorectal Cancer
- Interventions
- Fruquintinib+ Lonsurf (trifluridine and tipiracil), Fruquintinib
- First posted
- 2025-05-28
- Last updated
- 2026-10-15
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | To estimate the progression-free survival (PFS) benefit of fruquintinib in combination with TAS-102 as compared to fruquintinib | 24 months | Progression free survival (PFS) defined as time from randomization to first observation of progression using RECIST v1.1 or death from any cause. |
| Secondary | Estimate the confirmed objective response rate (ORR) of fruquintinib in combination with TAS-102 as compared to fruquintinib | 24 months | Objective response rate (ORR) defined as partial response or complete response using RECIST v1.1 |
| Secondary | Estimate the disease control rate (DCR) of fruquintinib in combination with TAS-102 as compared to fruquintinib | 24 months | Disease control rate (DCR) defined as partial response, complete response, or stable disease using RECIST v1.1 |
| Secondary | Estimate the clinical benefit rate (CBR) of fruquintinib in combination with TAS-102 as compared to fruquintinib | 24 months | Clinical benefit rate (CBR defined as the percentage of patients achieving a partial response, complete response, or stable disease for at least 6 months using RECIST v1.1 |
| Secondary | Estimate the overall survival (OS) of fruquintinib in combination with TAS-102 as compared to fruquintinib | 24 months | Overall survival (OS) defined as time from randomization to death from any cause |
| Secondary | Characterize the toxicity profile of fruquintinib in combination with TAS-102 | 24 months | Toxicity profile comprised of: Incidence of grade 3 or more treatment-related adverse events (TRAE), Percent of patients requiring dose reductions or dose delays due to TRAE, Percent of patients requiring treatment discontinuation due to TRAE |
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.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone 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/NCT06992258
GET https://conductscience.org/api/trials/v1/NCT06992258/registered