Spots Global Cancer Trial Database for Efficacy and Safety of Pyrotinib in HER2 Positive Gastrointestinal Tumors
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Trial Identification
Brief Title: Efficacy and Safety of Pyrotinib in HER2 Positive Gastrointestinal Tumors
Official Title: Efficacy and Safety of Pyrotinib in Patients With HER2 Positive Refractory or Metastatic Gastrointestinal Tumors
Study ID: NCT04960943
Interventions
Study Description
Brief Summary: Targeting human epidermal factor receptor 2 (HER2) therapy have shown the anti-tumor efficacy in patients with HER2-positive gastrointestinal tumors. Pyrotinib is an irreversible small-molecule receptor tyrosine kinase inhibitor targeting both epidermal growth factor receptor (EGFR) and HER2. This study is designed to evaluate the efficacy and safety of Pyrotinib in patients with HER2 positive gastrointestinal tumors.
Detailed Description: This study is designed to evaluate the efficacy and safety of Pyrotinib in patients with HER2 positive gastrointestinal tumors. Three cohorts were designed for this trial. Cohort 1: patients with gastric cancer or esophageal adenocarcinoma receiving paclitaxel combined with pyrotinib for second-line therapy; Cohort 2: patients with gastric cancer or esophageal adenocarcinoma receiving pyrotinib monotherapy for third-line or posterior line therapy; Cohort 3: patients with colorectal cancer receiving pyrotinib combined with/without trastuzumab for third-line or posterior line therapy.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Fudan University Shanghai Cancer Center, Shanghai, Shanghai, China
Contact Details
Name: Xiaodong Zhu, phD
Affiliation: Fudan University
Role: PRINCIPAL_INVESTIGATOR
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