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NCT02602327
Tas-102 and Radioembolization With 90Y Resin Microspheres for Chemo-refractory Colorectal Liver Metastases
Phase 1 trial testing Tas-102 in Colon Cancer in 21 participants. Completed in 31 August 2021.
20 May 2021
Quick facts
| Lead sponsor | University of California, San Francisco |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 21 |
| Start date | 9 January 2017 |
| Primary completion | 20 May 2021 |
| Estimated completion | 31 August 2021 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Tas-102
- SIR-Sphere — full drug profile →
Conditions studied
- Colon Cancer — all drugs for Colon Cancer →
- Rectal Cancer — all drugs for Rectal Cancer →
- Liver Metastases — all drugs for Liver Metastases →
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):
-
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 -
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 -
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 -
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 -
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
Verify or expand the search:
- PubMed search for NCT02602327
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02602327 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of California, San Francisco
- Last refreshed: 1 August 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02602327.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing