Fruquintinib in the Cross-line Treatment of Refractory mCRC
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Fruquintinib Rechallenge third-line treatment with fruquintinib combined with PD-1 inhibitors fourth-line treatment with fruquintinib combined with TAS-102 |
Drug: Fruquintinib+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.
Drug: Fruquintinib+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.
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Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
To be enrolled in this study, patients must meet all of the following criteria:
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Age ≥18 years, ≤75 years;
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No gender limitation;
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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.
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Expected survival ≥12 weeks
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Must have at least one measurable lesion (RECIST1.1).
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Full organ and bone marrow function.
Exclusion Criteria:
Patients will not be admitted to the study if they meet any of the following criteria:
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Patients with contraindications to study drugs (fruquinitinib, PD-1 inhibitor, TAS-102);
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allergic to the investigational drug or any of its adjuncts;
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There are other non-investigational drugs during third-line and fourth-line treatment;
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Pregnant or lactating female subjects;
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Patients with a large number of pleural effusion or ascites requiring drainage;
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Patients considered unsuitable for inclusion in this study by the investigators.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | TONGJI Hospital, Tongji Medical College, Huazhong University of Science and Technology | Wuhan | Hubei | China | 430022 |
| 2 | Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Wuhan | Hubei | China | 430022 |
| 3 | Zhongnan Hospital of Wuhan University | Wuhan | Hubei | China | 430022 |
Sponsors and Collaborators
- Wuhan Union Hospital, China
Investigators
- Principal Investigator: Zhenyu Lin, Wuhan Union Hospital, China
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- HMPL-013-C2-CRC05