A Phase 2 interventional study of Icotinib in Adenocarcinoma of the Gastroesophageal Junction and Esophageal Carcinoma, sponsored by Betta Pharmaceuticals Co., Ltd.. Completed at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2019-07-05.
Sponsored by Betta Pharmaceuticals Co., Ltd. · Phase 2, Interventional, and Treatment
This study is designed to evaluate the efficacy and safety of icotinib in treating advanced carcinoma of the gastroesophageal junction and esophagus with EGFR overexpression (IHC 3+) or positive FISH, the primary endpoint is objective response rates.
Epidermal growth factor receptor (EGFR) signaling is critical for cancer cell proliferation, invasion, metastasis, and resistance to apoptosis.EGFR is overexpressed in many epithelial malignancies and therefore makes an attractive therapeutic target.This study is designed to evaluate the efficacy and safety of icotinib in treating advanced carcinoma of the gastroesophageal junction and esophagus with EGFR overexpression (IHC 3+) or positive FISH, the primary endpoint is objective response rates. Secondary endpoints include progress-free survival, overall survival, safety and so on.
6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.
This study's enrollment of 54 is above the median of 45 across 5,170 interventional studies indexed under Carcinoma.
Browse Carcinoma studies →Betta Pharmaceuticals Co., Ltd. is the lead sponsor of 79 studies on the registry; 19 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Icotinib: 250 mg is administered orally three times per day, until disease progression or unacceptable toxicity.
Drug: Icotinib
Icotinib: 250 mg is administered orally three times per day, until disease progression or untolerable toxicity.
Also known as: Conmana, BPI-2009
Objective response rates
Number of participants who achieve complete response or partial response. Either complete response (CR) or partial response (PR) will be evaluated by RECIST, confirmed at least 28 days following the date of the initial response.
Time frame: 2 months
Progression Free Survival
A duration from randomization date to disease progression(as defined by RECIST) or death. If a participant are known to have progressed, the time to progression is defined as the time from the date of randomization to the date of progression. Otherwise, a participant will be censored at the last date they are known not to be progressed.
Time frame: 5 months
Overall survival
Overall Survival is assessed via calculation of the time to death due to any cause. If a participant is known to have died, the time to death is defined as the time from the date of randomization to the date of death. Otherwise, a participant will be censored at the last date they are known to be alive.
Time frame: 9 months
This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Betta Pharmaceuticals Co., Ltd.