Actively Recruiting
Regorafenib Combined With TAS-102 Versus Regorafenib Monotherapy in Third or Later Line Therapy of mCRC
Led by Fudan University · Updated on 2023-08-01
101
Participants Needed
1
Research Sites
157 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to evaluate the clinical benefit of regorafenib combined with TAS-102 compared with regorafenib monotherapy in patients with metastatic colorectal cancer who have failed at least two lines of treatment, to explore the rationality of this combination therapy strategy and to obtain relevant survival and safety data.
CONDITIONS
Official Title
Regorafenib Combined With TAS-102 Versus Regorafenib Monotherapy in Third or Later Line Therapy of mCRC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed recurrent or metastatic colorectal adenocarcinoma
- Failed at least one prior standard first- or second-line therapy including fluoropyrimidine, oxaliplatin, irinotecan, and bevacizumab
- At least one measurable lesion with longest diameter ≥10 mm on spiral CT or ≥20 mm on conventional CT
- ECOG performance status of 0 to 2
- Life expectancy of at least 12 weeks
- Adequate bone marrow, liver, and kidney function within screening period
- Women of childbearing potential must use effective contraception
- Voluntary informed consent and willingness to participate in the study
You will not qualify if you...
- Proteinuria ≥2+ on dipstick or 24-hour urinary protein ≥1.0 g/24 h
- Abnormal blood clotting or bleeding tendency or receiving blood thinning treatments
- Risk of gastrointestinal bleeding including active ulcers or recent black stools or vomiting blood
- Received systemic antitumor therapy within 3 weeks prior to screening
- Uncontrolled high blood pressure despite medication or significant heart disease or arrhythmia
- History of thrombotic or embolic events requiring treatment within past 6 months
- Prior radiation therapy targeting the study lesion
- Symptomatic brain or meningeal metastases
- Uncontrolled fluid accumulation in chest or abdomen
- Receiving kidney dialysis
- Serious or uncontrolled infections
- Pregnant or breastfeeding women or women without adequate contraception
- Conditions affecting oral drug intake such as swallowing difficulties or bowel obstruction
- Prior treatment with tyrosine kinase inhibitors targeting VEGFR
- Prior treatment with TAS-102
- Participation in another clinical trial within 4 weeks prior to screening
- Comorbidities that could seriously risk safety or study completion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here