This study is a prospective, multi-cohort clinical trial designed to evaluate the preliminary efficacy and safety of zanidatamab in combination with tislelizumab and chemotherapy/radiotherapy for patients with HER2-positive locally advanced or metastatic gastrointestinal tumors.
Clinical diagnosis of gastric cancer and colorectal cancer
Able to sign a written informed consent form and understand and comply with the requirements and evaluation schedule of this study
Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1
HER2-Positive: Immunohistochemistry (IHC) 3+ or IHC 2+ with FISH+ or NGS testing for high expression
History of or concurrent other malignancies, except for basal cell carcinoma of the skin, superficial bladder cancer, squamous cell carcinoma of the skin, or carcinoma in situ, provided complete remission was achieved at least 5 years prior to screening and no additional treatment is required or anticipated during the study period.
Cardiac chest pain occurring ≤28 days prior to the first study drug administration, defined as moderate pain limiting daily activities or exercise
Symptomatic pulmonary embolism within ≤28 days prior to the first dose of study drug
History of any acute myocardial infarction within ≤6 months prior to the first dose of study drug
Tao Zhang
Lead sponsor
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Sponsor institution