Tas-102 and Radioembolization With 90Y Resin Microspheres for Chemo-refractory Colorectal Liver Metastases
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|ClinicalTrials.gov Identifier: NCT02602327|
Recruitment Status : Recruiting
First Posted : November 11, 2015
Last Update Posted : June 19, 2018
|Condition or disease||Intervention/treatment||Phase|
|Colon Cancer Rectal Cancer Liver Metastases||Drug: Tas-102 Device: SIR-Sphere||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I Study of Tas-102 and Radioembolization With 90Y Resin Microspheres for Chemo-refractory Colorectal Liver Metastases|
|Study Start Date :||October 2016|
|Estimated Primary Completion Date :||September 2019|
|Estimated Study Completion Date :||September 2020|
Experimental: Tas-102 and radioembolization
Combination therapy with Tas-102 and radioembolization using 90Y resin microspheres
Oral nucleoside antitumor agent consisting of α,α,α-trifluorothymidine (FTD) and 5-chloro-6-(2-iminopyrrolidin-1-yl) methyl-2,4 (1H,3H)-pyrimidinedione hydro chloride (TPI) at a molar ratio of 1:0.5.
Other Name: Lonsurf
20-60mm resin microspheres containing Yttrium-90 (90Y, Y90) radioisotope
Other Name: Yttrium-90 (Y90; 90Y) resin microspheres
- Safety (adverse events) [ Time Frame: 4 years ]Safety (adverse events) of Tas-102 and 90Y radioembolization combination therapy.
- Radiographic response [ Time Frame: 4 years ]Radiographic overall response rate (measured in accordance to Response Evaluation Criteria in Solid Tumors [RECIST] version 1.1)
- Progression-free survival (PFS) [ Time Frame: 4 years ]Progression-free survival (PFS) following Tas-102 and 90Y radioembolization combination therapy (based on radiographic response).
- Hepatic progression-free survival (HPFS) [ Time Frame: 4 years ]
- Extrahepatic progression free survival (EHPFS) [ Time Frame: 4 years ]
- Overall survival (OS) [ Time Frame: 4 years ]
- Biomarker response [ Time Frame: 4 years ]Proportion of patients with carcinoembryonic antigen (CEA) response with ≥ 50% decline from baseline (in patients with baseline level ≥ 3.2) post combination therapy with Tas-102 and 90Y radioembolization.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02602327
|Contact: Curt Johanson||(415) 353-2310||Curt.Johanson@ucsf.edu|
|United States, California|
|University of California San Francisco||Recruiting|
|San Francisco, California, United States, 94143|
|Contact: Curt Johanson 415-353-2310 email@example.com|
|Principal Investigator: Nicholas Fidelman, MD|
|Principal Investigator:||Nicholas Fidelman, MD||University of California, San Francisco|
|Principal Investigator:||Katherine Van Loon, MD||University of California, San Francisco|