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Trial Title:
Fruquintinib in the Cross-line Treatment of Refractory mCRC
NCT ID:
NCT06099314
Condition:
Fruquintinib
Metastatic Colorectal Cancer
Conditions: Official terms:
Colorectal Neoplasms
Immune Checkpoint Inhibitors
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Retrospective
Intervention:
Intervention type:
Drug
Intervention name:
Fruquintinib+PD-1 inhibitors
Description:
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.
Arm group label:
Fruquintinib Rechallenge
Intervention type:
Drug
Intervention name:
Fruquintinib+TAS-102
Description:
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.
Arm group label:
Fruquintinib Rechallenge
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.
Criteria for eligibility:
Study pop:
Patients with metastatic colorectal cancer
Sampling method:
Non-Probability Sample
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Locations:
Facility:
Name:
TONGJI Hospital, Tongji Medical College, Huazhong University of Science and Technology
Address:
City:
Wuhan
Zip:
430022
Country:
China
Status:
Recruiting
Contact:
Last name:
Dongbo Liu
Facility:
Name:
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Address:
City:
Wuhan
Zip:
430022
Country:
China
Status:
Recruiting
Contact:
Last name:
ZhenYu Lin
Facility:
Name:
Zhongnan Hospital of Wuhan University
Address:
City:
Wuhan
Zip:
430022
Country:
China
Status:
Recruiting
Contact:
Last name:
wenbo wang
Start date:
October 2023
Completion date:
September 2025
Lead sponsor:
Agency:
Wuhan Union Hospital, China
Agency class:
Other
Source:
Wuhan Union Hospital, China
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06099314
