Actively Recruiting
Sequential TAS-OX Alternating With TAS-IRI Plus Bevacizumab for Late-Line Metastatic Colorectal Cancer
Led by Rutgers, The State University of New Jersey · Updated on 2026-03-18
50
Participants Needed
9
Research Sites
206 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is to evaluate the disease control rate and time to progression of the sequential combination of oxaliplatin with an alternative anti-metabolite Trifluridine/tipiracil hydrochloride mixture, TAS-102,(TAS-OX) as well as irinotecan in combination with TAS-102 oxaliplatin(TAS-OX) + Bevacizumab in late-line metastatic colorectal cancer (mCRC)
CONDITIONS
Official Title
Sequential TAS-OX Alternating With TAS-IRI Plus Bevacizumab for Late-Line Metastatic Colorectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed stage IV colon cancer that has progressed after standard therapy including 5-FU, irinotecan, oxaliplatin, and appropriate antibody therapy
- Prior adjuvant chemotherapy allowed if recurrence occurred during or within six months of completion
- Documented disease progression on most recent scan
- Presence of measurable disease
- RAS mutation and MMR status known or tissue available for testing
- Age 18 years or older
- ECOG performance status 0-1
- Life expectancy of at least three months
- Adequate organ function including ANC > 1.5 x 10^9/L, hemoglobin > 9 g/dL, platelets > 70 x 10^9/L, AST/ALT < 5 x ULN, and normal albumin
- Women who are nursing must stop nursing before enrollment
- Ability to take oral medication (no feeding tube)
- Willingness and ability to comply with study procedures and provide informed consent
You will not qualify if you...
- Prior treatment with TAS-102
- Grade 3 or higher peripheral neuropathy causing functional impairment
- Previous intolerance to irinotecan due to uncontrolled diarrhea
- Symptomatic central nervous system metastases requiring treatment
- Other active malignancies within the last three years except certain skin and in situ cancers
- Pregnancy or breastfeeding
- Current treatment with other investigational agents
- Active infection with fever above 38�b0C
- Major surgery within the past four weeks without fully healed incision
- Any anticancer therapy within two weeks prior to first study dose
- History of allergic reactions to TAS-102 related compounds
- Grade 3 or higher hypersensitivity to oxaliplatin or irinotecan, or uncontrolled lower grade reactions to oxaliplatin
- Unresolved toxicity of grade 2 or higher from previous treatments (excluding specified conditions)
AI-Screening
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Trial Site Locations
Total: 9 locations
1
Trinitas Hospital and Comprehensive Cancer Center
Elizabeth, New Jersey, United States, 07202
Actively Recruiting
2
RWJBarnabas Health Jersey City Medical Center
Jersey City, New Jersey, United States, 07302
Actively Recruiting
3
RWJBarnabas Health - Monmouth Medical Center Southern Campus
Lakewood, New Jersey, United States, 08701
Actively Recruiting
4
Cooperman Barnabas Medical Center (Saint Barnabas Medical Center)
Livingston, New Jersey, United States, 07039
Actively Recruiting
5
RWJBarnabas Health - Monmouth Medical Center
Long Branch, New Jersey, United States, 07740
Actively Recruiting
6
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08903
Actively Recruiting
7
RWJBarnabas Health - Robert Wood Johnson University Hospital
New Brunswick, New Jersey, United States, 08903
Actively Recruiting
8
RWJBarnabas Health - Robert Wood Johnson University Hospital
Somerset, New Jersey, United States, 08873
Actively Recruiting
9
RWJBarnabas Health - Community Medical Center
Toms River, New Jersey, United States, 08755
Actively Recruiting
Research Team
H
Howard S. Hochster, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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