Status:
COMPLETED
Fruquintinib With PD-1 Inhibitors Versus TAS-102 With Bevacizumab in Late-Line mCRC
Lead Sponsor:
Hunan Cancer Hospital
Conditions:
Metastatic Colorectal Adenocarcinoma
Eligibility:
All Genders
18-75 years
Brief Summary
Fruquintinib with PD-1 inhibitors (FP) and TAS-102 with bevacizumab (TB) are two common therapies for patients with previous-treated metastatic colorectal cancer (mCRC). However, it's still not clear ...
Detailed Description
This is a retrospective cohort study conducted in Hunan Cancer Hospital. Patients (pts) with mCRC who had received at least the 2nd line treatment were eligible. Propensity score (PS) would be calcula...
Eligibility Criteria
Inclusion
- Has histologically confirmed unresectable adenocarcinoma of the colon or rectum (all other histological types are excluded).
- Have progressed from at least 2 lines of standard treatment,including fluoropyrimidines, irinotecan, oxaliplatin, with or without targeted drugs, like bevacizumab and cetuximab (only for RAS wild-type). Regorafenib was permitted but not required for inclusion.
- Has measurable or non-measurable disease as defined by RECIST version 1.1
- Is able to swallow oral tablets.
- Estimated life expectancy ≥12 weeks.
- Eastern Cooperative Oncology Group performance status (ECOG PS) less than 2
- Has adequate organ function.
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.
- Known carriers of HIV antibodies.
- Confirmed uncontrolled arterial hypertension or uncontrolled or symptomatic arrhythmia.
Key Trial Info
Start Date :
July 1 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 31 2023
Estimated Enrollment :
106 Patients enrolled
Trial Details
Trial ID
NCT06031376
Start Date
July 1 2019
End Date
March 31 2023
Last Update
September 11 2023
Active Locations (1)
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1
Hunan Cancer hospital
Changsha, Hunan, China