Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a prospective, single arm, multicenter phase II study to assess the effectiveness of Serplulimab,Trastuzumab and SOX in the adjuvant treatment of HER-2 Positive Gastric/Gastroesophageal Junction Carcinoma (GC/GEJC)
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Serplulimab,Trastuzumab and SOX | Experimental | Within 4 weeks after surgery, patients will be enrolled in the study and started on Serplulimab (300mg, q3w) + Trastuzumab (First dose 8mg/kg, maintenance 6mg/kg, q3w) + oxaliplatin (130mg/m2, q3w) + Tegafur (40mg/m2, bid d1-d14, q3w). Among them, oxaliplatin + Teggio can be used for 4-6 cycles according to the patient's tolerance, and Serplulimab + trastuzumab can be continued until 12 months or tumor recurrence or metastasis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Serplulimab | Drug | 300mg, q3w |
| |
| Trastuzumab |
| Measure | Description | Time Frame |
|---|---|---|
| Disease progression free survival (DFS) | Objective response rate according to RECIST 1.1 | 24 months after the last subject participating in |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival (OS) | Overall survival | 24 months after the last subject participating in |
| Recurrence rate | Objective response rate according to RECIST 1.1 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Feng Wang | Contact | 13938244776 | fengw010@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Feng Wang | The First Affiliated Hospital of Zhengzhou University | Principal Investigator |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000068878 | Trastuzumab |
| D000077150 | Oxaliplatin |
| D005641 | Tegafur |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
First dose 8mg/kg, maintenance 6mg/kg, q3w |
|
| Oxaliplatin + Tegafur | Drug | oxaliplatin (130mg/m2, q3w) + Tegafur (40mg/m2, bid d1-d14, q3w). |
|
|
| 24 months after the last subject participating in |
| Safety and tolerability based on incidence of treatment-emergent adverse events as assessed by CTCAE | Safety and tolerability based on incidence of treatment-emergent adverse events as assessed by CTCAE | through study completion, an average of 1 year |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |