A Phase 4 interventional study of Nimotuzumab plus S1 and Placebo plus S1 in Unresectable Pancreatic Cancer, sponsored by Chinese PLA General Hospital. Status unknown at 7 sites in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2016-10-26.
Sponsored by Chinese PLA General Hospital · Phase 4, Interventional, and Treatment
Background: Monotherapy with S-1, oral fluoropyrimidine, shows non-inferiority to gemcitabine in overall survival (OS) with good tolerability for advanced pancreatic cancer in Asian patients. It is also shown that nimotuzumab plus gemcitabine could improve OS and progression free survival (PFS) in patients with unresectable pancreatic cancer. However, it is still unknown whether nimotuzumab plus S1 would improve more to OS and PFS than single S-1. Maintenance treatment, as a new treatment pattern, has also been tried in these patients after first line treatment to improve the OS. Thus, this study is designed to compare nimotuzumab plus S1 to placebo plus S1 as maintenance treatment in patients with locally advanced or metastatic pancreatic cancer who has benefited from the first-line treatment of gemcitabine combined with nimotuzumab and S1 (complete response+partial response+stable disease).
Patients and methods: 60 patients will be enrolled,and randomized in a 1:1 ratio to group nimotuzumab plus S1 and group placebo plus S1. nimotuzumab/placebo: 400 mg/w, intravenous infusion, Infusion time ≥ 60 min, d1, once every two weeks. S1: oral, 40 mg (Body surface area\<1.5 m2) or 60 mg (Body surface area>1.5 m2), d1-d14, every three weeks for a cycle. Treatment interventions will be stopped under the conditions of disease progression or intolerable toxic reaction or participants ask to quit. The primary endpoint is the time to disease progression since randomization (TTP), secondary points include OS, 3 years overall survival rate (OSR) and safety.
3,236 studies on the registry are indexed under Pancreatic Neoplasms; 900 are open to participants now.
This study's planned enrollment of 60 is above the median of 46 across 2,425 interventional studies indexed under Pancreatic Neoplasms.
Browse Pancreatic Neoplasms studies →Chinese PLA General Hospital is the lead sponsor of 558 studies on the registry; 202 are open to participants now.
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Exclusion Criteria:
Nimotuzumab Injection:400 mg/w, Intravenous infusion, Infusion time ≥ 60 min, d1, once every two weeks; S1:40 mg (Body surface area\<1.5 m2) or 60mg (Body surface area\>1.5 m2) ,oral,d1-d14, every three weeks for a cycle
Drug: Nimotuzumab plus S1
Placebo:400 mg/w, Intravenous infusion, Infusion time ≥ 60 min, d1, once every two weeks; S1:40 mg (Body surface area\<1.5 m2) or 60 mg (Body surface area\>1.5 m2) ,oral,d1-d14, every three weeks for a cycle
Drug: Placebo plus S1
Nimotuzumab Injection: 400 mg/w, Intravenous infusion, Infusion time ≥ 60 min, d1, once every two weeks;S1: 40 mg (Body surface area\<1.5 m2) or 60 mg (Body surface area\>1.5 m2) ,oral,d1-d14, every three weeks for a cycle
Also known as: Taixinsheng，Tegafur Gimeracil Oteracil Potassium Capsule
Placebo: 400 mg/w, Intravenous infusion, Infusion time ≥ 60 min, d1, once every two weeks;S1: 40 mg (Body surface area\<1.5 m2) or 60 mg (Body surface area\>1.5 m2) ,oral,d1-d14, every three weeks for a cycle
Also known as: Tegafur Gimeracil Oteracil Potassium Capsule
TTP
Time frame: 3 years
OS
Time frame: 3 years
OSR
Time frame: 1-3 years
Adverse Events
Time frame: 3 years
Plan to share: Yes
No publications or documents are linked to this record.
This study is status unknown, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.
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Chinese PLA General Hospital