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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.);
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Camrelizumab +Pyrotinib + Nab-paclitaxel + Tegafur | Experimental | Camrelizumab Q3W d1 Pyrotinib d1-21 Nab-paclitaxel Q3W d1 Tegafur d1-14 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Camrelizumab +Pyrotinib + Nab-paclitaxel + Tegafur | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| ORR (Objective control rate) | The rate of CR and PR, determined using RECIST v1.1 criteria | up to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| DCR (Disease control rate) | The rate of CR, PR plus SD | up to 12 months |
| PFS (Progression-Free survival) | From the date Into this study (signed ICF) to tumor progression or death for any |
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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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nan Zhang, doctor | Contact | 18940253560 | zhangnan2515@163.com | |
| Nan Niu, doctor | Contact | 18940256668 | niun@sj-hospital.org |
| Name | Affiliation | Role |
|---|---|---|
| Caigang Liu, doctor | Shengjing Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shengjing Hospital of China Medical University | Recruiting | Shenyang | China |
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| ID | Term |
|---|---|
| C520255 | 130-nm albumin-bound paclitaxel |
| D005641 | Tegafur |
| ID | Term |
|---|---|
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 |
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| up to 12 months |
| OS(Overall survival) | Baseline until death from any cause | up to approximately 24 months |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |