Patients with HER-2 positive malignant tumors, including breast cancer and gastric cancer
Conditions
Interventions
NA:medication
Sponsors
ShangHai ChangHai Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Age 18 or older, gender not limited; 2.HER-2 positive malignant tumors confirmed by histopathological examination in various central laboratories; 3.Observation Cohort 1: HER-2 positive malignant tumor patients, including breast cancer and gastric cancer, who are planned to receive Trastuzumab Injection (first use of AK-HER2) monotherapy or combination therapy; Observation Cohort 2: HER-2 positive breast cancer patients who are planned to receive Trastuzumab Injection (first use of AK-HER2) and pyrotinib combination therapy; Observation Cohort 3: HER-2 positive advanced gastric cancer patients who are planned to receive Trastuzumab Injection (first use of AK-HER2) and PD-1 inhibitor combination therapy. 4.Conscious, free from mental disorders, and with good compliance, following doctor's advice for treatment and follow-up. 5.Willing to participate in this study and sign the ICF,or exemption from informed consent approved by an Independent Ethics Committee (IEC).
Exclusion criteria
Exclusion criteria: 1.Pregnant or planning to become pregnant women, and lactating women; 2.Patients with allergic constitution and known or suspected allergy to the drugs under observation; 3.Patients who have participated in or plan to participate in other interventional studies within the past 4 weeks (patients who have participated in immunotherapy studies within the past 12 weeks and experienced irAEs that threaten the safety of the subjects); 4.Subjects who are considered by the researchers to be unsuitable for participation in this study due to other reasons;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety Evaluation; | — |
Secondary
| Measure | Time frame |
|---|---|
| Complete pathologic remission rate;Disease-free survival;Objective Response Rate;Disease Control Rate;Progression Free Survival;Overall Survival; | — |
Countries
China
Contacts
Public ContactXianbao Zhan
ShangHai ChangHai Hospital
Outcome results
None listed