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
Parallel
short-course radiotherapy
Radiation25Gy, 5Gy×5
Zanidatamab
Drug1800mg(\<70kg)/2400mg(≥70kg), IV，D1，Q3W
Tisleizumab(BGB-A317)
Drug200 mg，IV，D1，Q3W
Capecitabine
Drug1000mg/m2/time，BID，PO，D1-14, Q3W
Oxaliplatin
Drug130 mg/m2/次，IV，D1, Q3W
TME surgery
Procedure/SurgeryThe surgery was performed 4 - 6 weeks after the end of neoadjuvant therapy in patients who assessed as non-cCR.
S-1
Drug40\~60mg bid，po, d1\~14，Q3W （S-1：BSA \<1.25m2, 40mg bid, 1.25m2≤BSA≤1.5m2,50mg bid, BSA\>1.5m2, 60mg bid）
D2
Procedure/SurgeryRadical gastrectomy with D2 lymph node dissection was performed within 4-6 weeks after the completion of neoadjuvant therapy in patients without tumor progression on preoperative imaging assessment.
Complete Response Rate (CR Rate)
The CR rate is defined as the sum of the pathological complete response rate (pCR rate) and the clinical complete response rate (cCR rate). To evaluate the preliminary efficacy of Zanidatamab in combination with Tislelizumab and chemoradiotherapy in neoadjuvant and organ-preserving treatment for patients with HER2-Positive locally advanced rectal cancer.
Pathological Complete Response Rate (pCR Rate)
Following completion of 9 weeks of neoadjuvant therapy, an assessment will be conducted after radical surgical treatment.
Progression-Free Survival (PFS)
The time interval from the start of the first treatment (date of administration of zenidatumab or tislelizumab) to the date of the subject's first progression (PD) as assessed by the investigator using RECIST version 1.1
Adverse events (AEs) were graded according to the NCI CTCAE version 5·0
Adverse events and surgical safety
3-year disease-Free Survival
The time from the first day of disease free (operation date) to local or distant recurrence, or the death event caused by any reason, whichever occurs first time.
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Tao Zhang
Lead sponsor
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Sponsor institution
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