Anti-HER2 Therapy in Patients of HER2 Positive Metastatic Carcinoma of Digestive System

Phase 2 Unknown 100 enrolled Shen Lin

Non-randomizedParallel-groupOpen-labelTreatment

Summary

To seek the efficacy signals of trastuzumab in combination with chemotherapy in pretreated patients of HER2 positive, relapse or metastatic carcinoma of digestive system as response rate (RR) determined by the Investigator using RECIST 1.1, and provide evidence for phase III clinical trial.

Timeline

Start: 2017-07-01
Primary completion: 2021-07
Completion: 2021-09

Publications

Xu T, Wang X, Xin Y, Wang Z, Gong J, Zhang X, Li Y, Ji C, Sun Y, Zhao F, Huang D, Bai Y, Li J, Shen L. Trastuzumab Combined with Irinotecan in Patients with HER2-Positive Metastatic Colorectal Cancer: A Phase II Single-Arm Study and Exploratory Biomarker Analysis. Cancer Res Treat. 2023 Apr;55(2):626-635. doi: 10.4143/crt.2022.1058. Epub 2022 Dec 23.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Trastuzumab	Monoclonal antibody	6 mg/kg	Intravenous
Background	Capecitabine	Small molecule	1000 mg/m2	—
Background	Irinotecan	Small molecule	120 mg/m2	Intravenous
Background	fluorouracil	Small molecule	720 mg/m2	Intravenous

Anti-HER2 Therapy in Patients of HER2 Positive Metastatic Carcinoma of Digestive System

Summary

Timeline

Publications

Drugs

Indications