New drug cocktail shows promise for Late-Stage colon cancer
NCT ID NCT05806931
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a new way of giving three chemotherapy drugs (TAS-102, oxaliplatin, and irinotecan) along with bevacizumab to people with advanced colorectal cancer that has stopped responding to standard treatments. The goal is to see if this approach can control the cancer and slow its growth. About 50 adults with stage IV colon or rectal cancer will take part.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 50 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2023
- Expected to finish
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May 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Histologically confirmed stage IV colon cancer (AJCC 7th edition) that has progressed after standard therapy that included 5-FU, irinotecan, oxaliplatin and appropriate antibody therapy. Antibody therapy with bevacizumab and an anti-EGFR antibody, if RAS wild type, should have been given unless medical reasons have precluded their use. Participants who could not tolerate standard agents because of unacceptable, but reversible toxicity necessitating their discontinuation will be allowed to participate. * Participants who had received adjuvant chemotherapy and had recurrence during or within six months of completion of the adjuvant chemotherapy will be allowed to count the adjuvant therapy as one chemotherapy regimen for advanced disease. * Progression of disease must be documented on the most recent scan. * Presence of measurable disease * RAS mutation and MMR status must be determined (or tissue availability for testing if not already determined). * Age 18 years or older. * ECOG performance status 0-1. * Life expectancy of at least three months. * Participants with adequate organ function: 1. Absolute neutrophil count (ANC) \> 1.5 x 109/L 2. Hemoglobin \> 9 g/dL 3. Platelets (PLT) \> 70 x 109/L 4. AST/ALT \< 5 x ULN 5. Albumin within normal limits for institution * Women who are nursing and discontinue nursing prior to enrollment in the program. * Ability to take oral medication (i.e., no feeding tube). * Participant able and willing to comply with study procedures as per protocol. * Participant able to understand and willing to sign and date the written voluntary informed consent form (ICF) at screening visit prior to any protocol-specific procedures. Exclusion Criteria: * Participants who have previously received TAS-102. * Grade 3 or higher peripheral neuropathy (functional impairment). * Inability to tolerate irinotecan previously (due to uncontrolled diarrhea) * There are no specific exclusions for bevacizumab. Bevacizumab should be given unless there are specific contraindications per the treating investigator, which should be stated. If UPC is \>1.0 (as above) hold bevacizumab until proteinuria resolves and then start bevacizumab. * Symptomatic CNS metastases requiring treatment. * Other active malignancy within the last three years (except for non-melanoma skin cancer or a non-invasive/in situ cancer). * Pregnancy or breast feeding. * Current therapy with other investigational agents. * Active infection with body temperature \> 38°C due to infection. * Major surgery within prior four weeks (the surgical incision should be fully healed prior to drug administration). * Any anticancer therapy within prior two weeks of first dose of study drug. * History of allergic reactions attributed to compounds of similar chemical or biologic composition to TAS-102. * Current therapy with other investigational agents or participation in another clinical study or any investigational agent received within prior four weeks. * Grade 3 or higher hypersensitivity reaction to oxaliplatin or irinotecan, or grade 1-2 hypersensitivity reaction to oxaliplatin not controlled with pre-medication. * Has unresolved toxicity of greater than or equal to Common Terminology Criteria for Adverse (CTCAE) Grade 2 attributed to any prior therapies (excluding anemia, alopecia, skin pigmentation, and platinum-induced neurotoxicity).
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
9 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Cooperman Barnabas Medical Center (Saint Barnabas Medical Center)
RECRUITINGLivingston, New Jersey, 07039, United States
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RWJBarnabas Health - Community Medical Center
RECRUITINGToms River, New Jersey, 08755, United States
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RWJBarnabas Health - Monmouth Medical Center
RECRUITINGLong Branch, New Jersey, 07740, United States
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RWJBarnabas Health - Monmouth Medical Center Southern Campus
RECRUITINGLakewood, New Jersey, 08701, United States
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RWJBarnabas Health - Robert Wood Johnson University Hospital
RECRUITINGNew Brunswick, New Jersey, 08903, United States
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RWJBarnabas Health - Robert Wood Johnson University Hospital
RECRUITINGSomerset, New Jersey, 08873, United States
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RWJBarnabas Health Jersey City Medical Center
RECRUITINGJersey City, New Jersey, 07302, United States
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Rutgers Cancer Institute of New Jersey
RECRUITINGNew Brunswick, New Jersey, 08903, United States
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Trinitas Hospital and Comprehensive Cancer Center
RECRUITINGElizabeth, New Jersey, 07202, United States
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