This study will explore the efficacy and safety of tislelizumab (PD1 inhibitor) combined with DisitamabVedotin (ADC) and pyrotinib maleate (TKI) in the treatment of HER2-positive or mutated advanced colorectal cancer who have failed standard therapy .
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Tislelizumab: 200 mg, d1, intravenous infusion (ivgtt) administration, 21 days as a cycle. DisitamabVedotin : 2mg/kg, d1, intravenous drip (ivgtt) administration, 21 days as a cycle. Pyrotinib maleate tablets: 320 mg each time, Qd, orally administered within 30 minutes after breakfast, 21 days as a cycle. Continuous administration until disease progression, death, toxicity intolerance, withdrawal of informed consent, or other reasons specified in the protocol; for patients who still benefit after comprehensive evaluation after initial disease progression, the investigator may decide whether to continue the treatment with the experimental drug .
Objective Response Rate (ORR)
It is defined as the number of subjects with the best response effect as complete remission (CR) or partial remission (PR) during the period from the start of the subjects receiving the treatment regimen of this study to the progression of the subjects' disease in the total number of subjects in the analysis data set. percentage of the population(%).
Time frame: Up to 24 months
Disease Control Rate (DCR)
Defined as the number of subjects whose tumors shrank or remained stable for a certain period of time from receiving the treatment regimen of this study to the progression of the subject's disease, including complete remission (CR) and partial remission (PR) in the analysis data set percentage of the total population(%).
Time frame: Up to 24 months
Progression Free Survival (PFS)
Defined as the time from randomization to tumor progression in any aspect or death from any cause(Unit: month). Assessed according to RECIST 1.1 criteria, analysis of this indicator included tumor evaluation results during study treatment and follow-up. If the patient has several indicators that can be judged as PD, the first indicator will be used for PFS analysis; recurrence, new lesions or death are considered to have reached the end of the study, and the patient is treated with other systemic or target-targeted anti-PD. Tumor treatment is also considered tumor progression.
Time frame: Up to 24 months
Overall survival (OS)
Defined as the time from randomization to death from any cause(Unit: month).
Time frame: Up to 24 months
Drug-Related Safety Indicators
Exposure to the investigational drug and incidence, nature, and severity of adverse events, including serious adverse events(n,%)。
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Time frame: Up to 24 months
Study on the mechanism of drug resistance after progression
Changes in HER2 status, HER2 gene, and HER2-related signaling pathways before and after treatment. Note: HER2 positive means that in the pathological detection/recheck of the primary or metastatic lesions performed by the pathology department, at least one tumor cell immunohistochemical staining intensity of 3+ or immunohistochemical staining intensity of 2+ and fluorescence in situ hybridization Technical \[FISH\] confirmed positive or NGS confirmed advanced colorectal cancer patients with HER2 gene amplification or mutation.
Time frame: Up to 24 months