Fruquintinib, Metastatic Colorectal Cancer
Conditions
Brief summary
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.
Detailed description
This is a real-world study. 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. The primary endpoint was observation the overall survival (OS) of fourth-line treatment of mCRC with fruquinitinib and TAS-102. The study objective is to explore the possibility of cross-line rechallenge of fruquinitinib.
Interventions
DRUGFruquintinib+PD-1 inhibitors
Third-line treatment with fruquintinib combined with PD-1 inhibitors. Fruquintinib: 5mg,Oral once daily,2 weeks on/1 week off,Q3W； PD-1 inhibitor：for example, Sintilimab,iv,200mg, Q3W.
DRUGFruquintinib+TAS-102
Fourth-line treatment with fruquintinib combined with TAS-102 . Fruquintinib: 3-5mg(Depending on the patient's physical condition), Oral once daily,3 weeks on/1 week off,Q4W； TAS-102:orally, 35mg/m2 twice daily (maximum dose 80mg in a single dose) for days 1-5, repeated every 14 days.
Sponsors
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival 2(OS2) | 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 | Overall survival (OS) of fourth-line treatment of mCRC with fruquinitinib and TAS-102 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective response rate 2(ORR2, investigator based on RECIST1.1) | from received fruquinitinib combined with TAS-102 to one year | Objective response rate (ORR) of fourth-line treatment of mCRC with fruquinitinib and TAS-102 |
| Progression-free survival 2(PFS2, investigators based on RECIST1.1) | From the date of first fruquinitinib combined with TAS-102 treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months | Progression-free survival (PFS) of fourth-line treatment of mCRC with fruquinitinib and TAS-102 |
| Disease control rate 2 (DCR2, investigators based on RECIST1.1) | from received fruquinitinib combined with TAS-102 to one year | Disease control rate (DCR) of fourth-line treatment of mCRC with fruquinitinib and TAS-102 |
Countries
China
Contacts
Primary ContactZhenyu Lin
Outcome results
None listed