HER2-positive Gastric Cancer
Conditions
Brief summary
According to the investigator's judgment, there are concomitant diseases that seriously endanger the patient's safety, or affect the patient's completion of the study (such as uncontrolled hypertension, diabetes, thyroid disease, etc.);
Interventions
DRUGCamrelizumab +Pyrotinib + Nab-paclitaxel + Tegafur
Camrelizumab was given in the first day of each cycle,Nab-paclitaxel was given in the first day of each cycle, Pyrotinib was given everyday of each cycle, Tegafur given in the day 1-14 of each cycle
Sponsors
Shengjing Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
\- rious hepatic and renal impairment, organ function must meet the following requirements: ANC ≥ 1.5 × 109/L; PLT ≥ 90 × 109/L; Hb ≥ 90g/L; TBIL ≤ 1.5 × ULN; ALT and AST ≤1.5 × ULN, ALP ≤ 2.5 × ULN; for patients with liver metastases, ALT and AST ≤ 5 × ULN BUN and Cr ≤ 1 × ULN and cre
Exclusion criteria
* rious hepatic and renal impairment, organ function must meet the following requirements: ANC ≥ 1.5 × 109/L; PLT ≥ 90 × 109/L; Hb ≥ 90g/L; TBIL ≤ 1.5 × ULN; ALT and AST ≤1.5 × ULN, ALP ≤ 2.5 × ULN; for patients with liver metastases, ALT and AST ≤ 5 × ULN BUN and Cr ≤ 1 × ULN and cre
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ORR (Objective control rate) | up to 12 months | The rate of CR and PR, determined using RECIST v1.1 criteria |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| DCR (Disease control rate) | up to 12 months | The rate of CR, PR plus SD |
| PFS (Progression-Free survival) | up to 12 months | From the date Into this study (signed ICF) to tumor progression or death for any |
| OS(Overall survival) | up to approximately 24 months | Baseline until death from any cause |
Countries
China
Contacts
Primary ContactNan Zhang, doctor
Backup ContactNan Niu, doctor
Outcome results
None listed