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NCT02602327

Tas-102 and Radioembolization With 90Y Resin Microspheres for Chemo-refractory Colorectal Liver Metastases

Completed Phase 1 Last updated 1 August 2022
What this trial tests

Phase 1 trial testing Tas-102 in Colon Cancer in 21 participants. Completed in 31 August 2021.

Timeline
9 January 2017
Primary endpoint
20 May 2021
31 August 2021

Quick facts

Lead sponsorUniversity of California, San Francisco
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment21
Start date9 January 2017
Primary completion20 May 2021
Estimated completion31 August 2021
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

University of California, San Francisco

Who can join

18 and older, any sex, with Colon Cancer or Rectal Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a phase I dose escalation study (3+3 design) with a dose expansion arm (12 patients) designed to evaluate safety of the combination of Tas-102 and radioembolization using Yttrium-90 (90Y) resin microspheres for patients with chemotherapy-refractory liver-dominant chemotherapy-refractory metastatic colorectal cancer (mCRC).

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Updated survival outcomes and analysis of long-term survivors from the MORE study on safety and efficacy of radioembolization in patients with unresectable colorectal cancer liver metastases.
    Kennedy A, Cohn M, Coldwell DM, Drooz A, et al · · 2017 · cited 38× · PMID 28890810 · DOI 10.21037/jgo.2017.03.10
  2. Safety of selective internal radiation therapy (SIRT) with yttrium-90 microspheres combined with systemic anticancer agents: expert consensus.
    Kennedy A, Brown DB, Feilchenfeldt J, Marshall J, et al · · 2017 · cited 32× · PMID 29299370 · DOI 10.21037/jgo.2017.09.10
  3. Phase I prospective trial of TAS-102 (trifluridine and tipiracil) and radioembolization with <sup>90</sup>Y resin microspheres for chemo-refractory colorectal liver metastases.
    Fidelman N, Atreya CE, Griffith M, Milloy MA, et al · · 2022 · cited 11× · PMID 36514060 · DOI 10.1186/s12885-022-10401-0
  4. Novel therapeutics in metastatic colorectal cancer: molecular insights and pharmacogenomic implications.
    Hanna DL, Lenz HJ. · · 2016 · cited 8× · PMID 27031164 · DOI 10.1586/17512433.2016.1172961
  5. Emerging combination therapies for metastatic colorectal cancer - impact of trifluridine/tipiracil.
    Puthiamadathil JM, Weinberg BA. · · 2017 · cited 7× · PMID 29056855 · DOI 10.2147/cmar.s113320

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Other recruiting trials for Colon Cancer

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