Status:
COMPLETED
Fruquintinib Plus PD-1 in Refractory MSS Metastatic Colorectal Cancer
Lead Sponsor:
Hunan Cancer Hospital
Conditions:
Colorectal Cancer
Eligibility:
All Genders
18-75 years
Brief Summary
The survival of the refractory CRC is dismal and therapy options are limited ，the researchers aim to investigate the efficacy, safety, and predictors of fruquintinib plus PD-1 in refractory MSS metast...
Detailed Description
The invesgators conducted a retrospective single arm, single-center study in which patients with MSS/pMMR mCRC were received fruquintinib combined with anti-PD-1 antibodies after progressed at least t...
Eligibility Criteria
Inclusion
- patients with MSS/pMMR mCRC who have been received Fruquintinib combined with anti-PD-1 antibodies after progressed at least two lines of standard chemotherapy with or without targeted drugs such as bevacizumab and cetuximab at the Hunan Cancer Hospital from 1th January 2019 to 30th June 2022;
- Eligible patients were aged 18 years or older
- had histologically or cytologically confirmed adenocarcinoma of the colon or rectum;
- patients who have at least one non-resectable measurable lesion to evaluate by response evaluation criteria in solid tumors (RECIST version 1.1).
- an Eastern Cooperative Oncology Group performance status of 0-2;
Exclusion
- Pregnancy, lactating female or possibility of becoming pregnant during the study.
- Has not recovered from clinically relevant non-hematologic CTCAE grade ≥ 3 toxicity of previous anticancer therapy (excluding alopecia, and skin pigmentation).
- Has symptomatic central nervous system metastases that are neurologically unstable or requiring increasing doses of steroids to control CNS disease.
- Has severe or uncontrolled active acute or chronic infection. 5.Known carriers of HIV antibodies. 6.Confirmed uncontrolled arterial hypertension or uncontrolled or symptomatic arrhythmia.
Key Trial Info
Start Date :
January 1 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 10 2023
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT06011330
Start Date
January 1 2019
End Date
February 10 2023
Last Update
August 30 2023
Active Locations (1)
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1
Hunan Cancer Hospital
Changsha, Hunan, China