Clinical trial · Observational
Fruquintinib in the Cross-line Treatment of Refractory mCRC
A Real-world Study of Fruquintinib in the Cross-line Treatment of Refractory mCRC
NCT06099314CI-TRIAL-00070779unknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a real-world study. Patients with metastatic colorectal cancer who have progressed (PD) after third-line treatment with fruquintinib combined with PD-1 inhibitors will receive fruquintinib combined with TAS-102 as fourth-line therapy. The objective of this study was to observe the efficacy and safety of cross-line（from third to fourth line）treatment with fruquinitinib.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Fruquintinib | — | UNRESOLVED | — |
| Metastatic Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fruquintinib+PD-1 inhibitors | Drug | — | UNRESOLVED |
| Fruquintinib+TAS-102 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Fruquintinib Rechallenge
- description
- 1. third-line treatment with fruquintinib combined with PD-1 inhibitors 2. fourth-line treatment with fruquintinib combined with TAS-102
- interventionNames
- Drug: Fruquintinib+PD-1 inhibitors
- Drug: Fruquintinib+TAS-102
Primary outcomes (1)
- measure
- Overall survival 2(OS2)
- timeFrame
- From the date of first fruquinitinib combined with TAS-102 treatment until the date of first documented date of death from any cause , assessed up to 12 months
- description
- Overall survival (OS) of fourth-line treatment of mCRC with fruquinitinib and TAS-102
Secondary outcomes (3)
- measure
- Objective response rate 2(ORR2, investigator based on RECIST1.1)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: \- To be enrolled in this study, patients must meet all of the following criteria: 1. Age ≥18 years, ≤75 years; 2. No gender limitation; 3. Patients with metastatic colorectal cancer confirmed by histopathology had previously received 2-line system therapy with fluorouracil, oxaliplatin, irinotecan, anti-VEGF, anti-EGFR (RAS and BRAF wild type) (treatment with anti-VEGF-TKI is not allowed), and had received fruquinitinib combined with PD-1 inhibitors for third-line treatment. After progression (PD) (confirmed by RECIST 1.1 ), fruquinitinib combined with TAS-102 as fourth-line therapy was received. 4. Expected survival ≥12 weeks 5. Must have at least one measurable lesion (RECIST1.1). 6. Full organ and bone marrow function. Exclusion Criteria: \- Patients will not be admitted to the study if they meet any of the following criteria: 1. Patients with contraindications to study drugs (fruquinitinib, PD-1 inhibitor, TAS-102); 2. allergic to the investigational drug or any of its adjuncts; 3. There are other non-investigational drugs during third-line and fourth-line treatment; 4. Pregnant or lactating female subjects; 5. Patients with a large number of pleural effusion or ascites requiring drainage; 6. Patients considered unsuitable for inclusion in this study by the investigators.
References
Publications (0)
Data not yet available
No reference posted for this study.