Trial · NCT07491159
Fruquintinib Plus Checkpoint Inhibitor Combined or Sequential TAS-102 in Colorectal Cancer Patients Who Progressed on Second-line Standard Therapy: a Prospective, Multi-cohort, Single-centered, Phase Ib/II Study
NCT07491159, Phase 1, Phase 2, Active not recruiting, Tianjin Medical University Cancer Institute and Hospital
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. Fruquintinib Plus Checkpoint Inhibitor Combined or Sequential TAS-102 in Colorectal Cancer Patients Who Progressed on Second-line Standard Therapy: a Prospective, Multi-cohort, Single-centered, Phase Ib/II Study. Trials, record NCT07491159. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07491159
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
Fruquintinib Plus Checkpoint Inhibitor Combined or Sequential TAS-102 in Colorectal Cancer Patients Who Progressed on Second-line Standard Therapy: a Prospective, Multi-cohort, Single-centered, Phase Ib/II Study
- NCT number
- NCT07491159
- Status
- Active not recruiting
- Phases
- Phase 1, Phase 2
- Enrollment
- 106 participants, estimated
- Lead sponsor
- Tianjin Medical University Cancer Institute and Hospital
- Conditions
- Colorectal Cancer
- Interventions
- Fruquintinib plus immunocheckpoint inhibitor plus trifluridine/tipiracil, Fruquintinib plus immunocheckpoint inhibitor followed by trifluridine/tipiracil plus bevacizumab
- First posted
- 2026-03-24
- Last updated
- 2026-03-24
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | RP2D | From enrollment to the end of treatment at 4 week | Recommended phase 2 dose |
| Primary | Overall Survival (OS) | Up to 36 months | Time from randomization/enrollment to death from any cause |
| Secondary | Progress-free Survival (PFS) | Assessed every 8 weeks, up to 12 months | Time from randomization/enrollment to first documented disease progression (per RECIST v1.1) or death from any cause, whichever occurs first |
| Secondary | Objective Response Rate (ORR) | Tumor assessments performed at baseline, then every 8 weeks (±7 days) from the date of first dose until radiographic disease progression or death, assessed up to approximately 12 months | The proportion of patients who achieve a confirmed complete response (CR) or partial response (PR) as their best overall response, as assessed by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 |
| Secondary | Duration of Response (DoR) | Up to 12 months | Time from first documented response (CR/PR) to disease progression or death |
| Secondary | Incidence of AEs | by NCI-CTCAE v5.0. From first dose up to 30 days after last dose | Number and percentage of participants experiencing adverse events graded by NCI-CTCAE v5.0 |
| Secondary | Incidence of SAEs | From informed consent up to 30 days after last dose | Number and percentage of participants experiencing serious adverse events |
| Secondary | Number of participants with Laboratory abnormalities | From baseline up to 30 days after last dose | Incidence of clinically significant laboratory parameter changes per NCI-CTCAE v5.0 |
| Other | Biomarker Analysis for Efficacy Prediction | Baseline, during treatment (every 8 weeks), and at disease progression, up to 24 months | To explore potential predictive biomarkers associated with treatment efficacy, including: Blood-based biomarkers (CEA, CTCs, VEGF) |
| Other | Tumor tissue biomarkers (TMB, DNA methylation status) | Baseline, during treatment (every 8 weeks), and at disease progression, up to 24 months | Biomarker Analysis for Efficacy Prediction |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes0
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/NCT07491159
GET https://conductscience.org/api/trials/v1/NCT07491159/registered