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OncoMatch/Clinical Trials/NCT05806931

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

Is NCT05806931 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies TAS-102, oxaliplatin, irinotecan with bevacizumab for colon cancer.

Phase 2RecruitingRutgers, The State University of New JerseyNCT05806931Data as of May 2026

Treatment: TAS-102, oxaliplatin, irinotecan with bevacizumabThis 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)

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Extracted eligibility criteria

Cancer type

Colorectal Cancer

Biomarker criteria

Required: KRAS mutation

RAS mutation and MMR status must be determined (or tissue availability for testing if not already determined)

Required: NRAS mutation

RAS mutation and MMR status must be determined (or tissue availability for testing if not already determined)

Required: MMR status determined

RAS mutation and MMR status must be determined (or tissue availability for testing if not already determined)

Allowed: KRAS wild-type

antibody therapy with bevacizumab and an anti-EGFR antibody, if RAS wild type, should have been given unless medical reasons have precluded their use

Allowed: NRAS wild-type

antibody therapy with bevacizumab and an anti-EGFR antibody, if RAS wild type, should have been given unless medical reasons have precluded their use

Disease stage

Required: Stage IV

Metastatic disease required

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Must have received: antimetabolite (5-FU)

progressed after standard therapy that included 5-FU

Must have received: topoisomerase inhibitor (irinotecan)

progressed after standard therapy that included irinotecan

Must have received: platinum-based chemotherapy (oxaliplatin)

progressed after standard therapy that included oxaliplatin

Must have received: antibody-drug conjugate (bevacizumab)

antibody therapy with bevacizumab ... should have been given unless medical reasons have precluded their use

Must have received: anti-EGFR antibody

antibody therapy with ... an anti-EGFR antibody, if RAS wild type, should have been given unless medical reasons have precluded their use

Cannot have received: (TAS-102)

Participants who have previously received TAS-102

Lab requirements

Blood counts

ANC > 1.5 x 10^9/L; Hemoglobin > 9 g/dL; Platelets > 70 x 10^9/L

Liver function

AST/ALT < 5 x ULN; Albumin within normal limits for institution

Participants with adequate organ function: 1. Absolute neutrophil count (ANC) > 1.5 x 10^9/L 2. Hemoglobin > 9 g/dL 3. Platelets (PLT) > 70 x 10^9/L 4. AST/ALT < 5 x ULN 5. Albumin within normal limits for institution

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • Trinitas Hospital and Comprehensive Cancer Center · Elizabeth, New Jersey
  • RWJBarnabas Health Jersey City Medical Center · Jersey City, New Jersey
  • RWJBarnabas Health - Monmouth Medical Center Southern Campus · Lakewood, New Jersey
  • Cooperman Barnabas Medical Center (Saint Barnabas Medical Center) · Livingston, New Jersey
  • RWJBarnabas Health - Monmouth Medical Center · Long Branch, New Jersey

Showing up to 5 US sites. See all sites on ClinicalTrials.gov →

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