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Sequential TAS-OX Alternating With TAS-IRI Plus Bevacizumab for Metastatic Colorectal Cancer

This study is testing a new way to treat advanced colon or rectal cancer that has spread (metastatic colorectal cancer or mCRC) and has already been treated with standard therapies. It combines several medications: TAS-102, oxaliplatin, irinotecan, and bevacizumab. You would receive TAS-102 and oxaliplatin (TAS-OX) alternating with TAS-102 and irinotecan (TAS-IRI), along with bevacizumab. The main goal is to see how many people have their cancer controlled by this treatment. You may be able to join if you are 18 or older, have mCRC, and your cancer has progressed after previous treatments including 5-FU, irinotecan, oxaliplatin, and appropriate antibody therapies. The study plans to enroll 50 participants, but its current status is unclear.

Study design
This is a Phase II interventional study that plans to enroll 50 participants. It will evaluate the effectiveness of the treatment.
What's involved
You will receive the study drugs until your cancer shows signs of growing or if you experience side effects that require stopping treatment.
Compensation
Not stated in the trial record.
Follow-up
Disease control will be measured from the start of the study until the cancer progresses, for up to 100 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05806931

Sequential TAS-OX Alternating With TAS-IRI Plus Bevacizumab for Late-Line Metastatic Colorectal Cancer

Recruiting
PHASE2Ages 18+InterventionalTreatment
Rutgers, The State University of New Jersey
~50 participants
Updated 2026-03-18 on ClinicalTrials.gov
What's tested:TAS-102, oxaliplatin, irinotecan with bevacizumab

At a glance

Recruiting sites
9 of 9 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Disease control rate (DCR):
Measured over From baseline until the date of first documented progression of disease, as assessed up to 100 months

Conditions

Colon Cancer
Rectal Cancer

Explore related trials

Colorectal Carcinoma

Where it's being run

9 sites across 1 states
New Jersey9

Study leadership

  • Howard S. Hochster, MD · PRINCIPAL_INVESTIGATOR · Cancer Institute of New Jersey Rutgers

Who to contact

Howard S. Hochster, MD
[email protected]
732-253-5618
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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:
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

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).

What this trial measures

  • Disease control rate (DCR):From baseline until the date of first documented progression of disease, as assessed up to 100 months

    Defined as the percentage of patients who have achieved complete response (CR), partial response (PR) and stable disease (SD). The disease control rate will be calculated along with 95% confidence interval. As Simon's two stage design is used in the study, 95% CI will be calculated for the two-stage nature of the study design. Response will be determined by independent radiologists using the RECIST criteria.