A Phase 3 interventional study of nab paclitaxel and Tegafur in Stomach Cancer, sponsored by Zhejiang Cancer Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2020-03-23.
Sponsored by Zhejiang Cancer Hospital · Phase 3, Interventional, and Treatment
This is a randomized, open-label phase III study. The treatment was compare the efficacy and safety of Albumin-bound Paclitaxel plus S-1 versus Oxaliplatin plus capecitabine (XELOX) treating stage Ⅲ gastric cancer as adjuvant setting
This is a randomized, open-label phase III study. The treatment was compare the efficacy and safety of Albumin-bound Paclitaxel plus S-1 versus Oxaliplatin plus capecitabine (XELOX) treating stage Ⅲ gastric cancer as adjuvant setting. The primary endpoint is the 3-year diseases-free survival (DFS) rate. The secondary endpoints are the overall survival (OS) and safety.
2,851 studies on the registry are indexed under Stomach Neoplasms; 864 are open to participants now.
This study's planned enrollment of 616 is above the median of 67 across 2,096 interventional studies indexed under Stomach Neoplasms.
Browse Stomach Neoplasms studies →Zhejiang Cancer Hospital is the lead sponsor of 271 studies on the registry; 116 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Arm A:nab paclitaxel (120mg/m2;iv;d1,8)+S-1 (\<1.25 m2, 40 mg; 1.25 to ≤1.5 m2, 50 mg; and ≥ 1.5 m2, 60 mg;po;d1-14 bid)Q3W;up to eight cycles
Drug: nab paclitaxel · Drug: Tegafur
Arm B:Capetabine(1000 mg/m2 po, d1-14 bid )+ Oxaliplatin(130mg/m2 , iv, d1)Q3W;up to eight cycles
Drug: Oxaliplatin · Drug: Capecitabine
nab paclitaxel (120mg/m2;iv;d1,8)
Also known as: albumin bound paclitaxel
S-1 (\<1.25 m2, 40 mg; 1.25 to ≤1.5 m2, 50 mg; and ≥ 1.5 m2, 60 mg;po;d1-14 bid)
Also known as: S-1
Oxaliplatin(130mg/m2 , iv, d1)
Capetabine(1000 mg/m2 po, d1-14 bid )
3 years Diseases-free Survival rate(3 years-DFS)
DFS is defined as time from the date of inclusion up to the date of disease progression or death
Time frame: up to 3 years
Overall survival (OS)
Overall survival is defined as time from the start of treatment until death due to any reason.
Time frame: up to 3 years
Safety as measured by number and grade of adverse events
Summary adverse events according to NCI-CTCAE 5.0
Time frame: up to 3 years
Plan to share: No
This study is status unknown, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.
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Zhejiang Cancer Hospital