Neoplasms

Digestive System Diseases

All Conditions

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Antineoplastic Agents

All Drugs and Chemicals

Paclitaxel

Trastuzumab

Albumin-Bound Paclitaxel

Antineoplastic Agents, Immunological

Pyrotinib with or without paclitaxel/trastuzumab treatment

After enrollment, patients of all the three cohorts were given 400 mg/d oral pyrotinib continuously, every 21 days as a cycle; Cohort 1 and 2 : Patients with gastric cancer or esophageal adenocarcinoma were combined with paclitaxel 80 mg/m2, intravenously, once on the first and eighth day. Cohort 3: Patients with colorectal cancer were given trastuzumab at an initial load dose of 8 mg/kg followed by 6 mg/kg every 3 weeks.

Pyrotinib with or without trastuzumab

Xiaodong Xiaodong, phD

Wenhua Li

Xiaodong Zhu, phD

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.

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.

Efficacy and Safety of Pyrotinib in HER2 Positive Gastrointestinal Tumors

Efficacy and Safety of Pyrotinib in Patients With HER2 Positive Refractory or Metastatic Gastrointestinal Tumors

evaluated in the 24th month since the treatment began

time to progression since the treatment began

the proportion of patients who had a best response

Number of Participants with treatment related Adverse Events as Assessed by CTCAE v5.0

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Efficacy and Safety of Pyrotinib in HER2 Positive Gastrointestinal Tumors	NCT04960943	Gastrointestina... Effect of Drug	Pyrotinib with ...	18 Years -	Fudan University
Efficacy and Safety of Pyrotinib in HER2 Positive Gastrointestinal Tumors	NCT04960943	Gastrointestina... Effect of Drug	Pyrotinib with ...	18 Years -	Fudan University

Spots Global Cancer Trial Database for pyrotinib with or without trastuzumab