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.
Treatment: TAS-102, oxaliplatin, irinotecan with bevacizumab — 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)
Check if I qualifyExtracted 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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