Recruiting
Phase 2

TAS-OX & TAS-IRI

Sponsor:

Rutgers, The State University of New Jersey

Code:

NCT05806931

Conditions

Colon Cancer

Rectal Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

TAS-102, oxaliplatin, irinotecan with bevacizumab

Study Details

Brief summary:

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

Colon Cancer

Rectal Cancer

Study ID

NCT05806931

Start date

May 17, 2023

Status verified date

Mar, 2026

Completion date

May 1, 2027

Anticipated

Primary completion date

May 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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).

Study Design

Enrollment

50 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Tolerability of TAS-102, oxaliplatin, irinotecan with bevacizumab

Each treatment cycle will be fourteen days long. TAS-102 25 mg/m2 will be taken orally twice daily on days 1-5 of each cycle. Oxaliplatin 85 mg/m2 infusion will be given on day one for one cycle alternating with Irinotecan 150 mg/m2 infusion, which will be given on day one the next cycle.

Interventions

TAS-102, oxaliplatin, irinotecan with bevacizumab

Participants will be treated with the study drugs until radiological evidence of disease progression or until treatment discontinuation secondary to adverse events. TAS-OX alternating with TAS-IRI (sequential TASOXIRI) with Bevacizumab, in the treatment of mCRC.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Howard S. Hochster, MD

732-253-5618howard.hochster@rutgers.edu

Locations

Trinitas Hospital and Comprehensive Cancer Center

Recruiting

Elizabeth, New Jersey, United States, 07202

Contacts

Howard S. Hochster, MD

732-253-5618howard.hochster@rutgers.edu

RWJBarnabas Health Jersey City Medical Center

Recruiting

Jersey City, New Jersey, United States, 07302

Contacts

Howard S. Hochster, MD

732-253-5618howard.hochster@rutgers.edu

RWJBarnabas Health - Monmouth Medical Center Southern Campus

Recruiting

Lakewood, New Jersey, United States, 08701

Contacts

Howard S. Hochster, MD

732-253-5618howard.hochster@rutgers.edu

Cooperman Barnabas Medical Center (Saint Barnabas Medical Center)

Recruiting

Livingston, New Jersey, United States, 07039

Contacts

Howard S. Hochster, MD

732-253-5618howard.hochster@rutgers.edu

RWJBarnabas Health - Monmouth Medical Center

Recruiting

Long Branch, New Jersey, United States, 07740

Contacts

Howard S. Hochster, MD

732-253-5618howard.hochster@rutgers.edu

Rutgers Cancer Institute of New Jersey

Recruiting

New Brunswick, New Jersey, United States, 08903

Contacts

Howard S. Hochster, MD

732-253-5618howard.hochster@rutgers.edu

RWJBarnabas Health - Robert Wood Johnson University Hospital

Recruiting

New Brunswick, New Jersey, United States, 08903

Contacts

Howard S. Hochster, MD

732-253-5618howard.hochster@rutgers.edu

RWJBarnabas Health - Robert Wood Johnson University Hospital

Recruiting

Somerset, New Jersey, United States, 08873

Contacts

Howard S. Hochster

732-253-5618howard.hochster@rutgers.edu

RWJBarnabas Health - Community Medical Center

Recruiting

Toms River, New Jersey, United States, 08755

Contacts

Howard S. Hochster

732-253-5618howard.hochster@rutgers.edu

More Information

Sponsor

Rutgers, The State University of New Jersey

Last update posted

Mar 18, 2026

Last verified

Mar, 2026

Keywords

  • Sequential Combined TAS-102
  • Oxaliplatin
  • Irinotecan
  • Late-Line Metastatic Colorectal Cancer
  • Bevacizumab

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Rutgers, The State University of New Jersey on 2026-03-18.