Status:
UNKNOWN
Fruquintinib in the Cross-line Treatment of Refractory mCRC
Lead Sponsor:
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Conditions:
Fruquintinib
Metastatic Colorectal Cancer
Eligibility:
All Genders
18-75 years
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 com...
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, ...
Eligibility Criteria
Inclusion
- \-
- To be enrolled in this study, patients must meet all of the following criteria:
- Age ≥18 years, ≤75 years;
- No gender limitation;
- 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.
- Expected survival ≥12 weeks
- Must have at least one measurable lesion (RECIST1.1).
- Full organ and bone marrow function.
Exclusion
- \-
- Patients will not be admitted to the study if they meet any of the following criteria:
- Patients with contraindications to study drugs (fruquinitinib, PD-1 inhibitor, TAS-102);
- allergic to the investigational drug or any of its adjuncts;
- There are other non-investigational drugs during third-line and fourth-line treatment;
- Pregnant or lactating female subjects;
- Patients with a large number of pleural effusion or ascites requiring drainage;
- Patients considered unsuitable for inclusion in this study by the investigators.
Key Trial Info
Start Date :
October 1 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 1 2025
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT06099314
Start Date
October 1 2023
End Date
September 1 2025
Last Update
October 25 2023
Active Locations (3)
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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