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 study is conducted in patients with advanced metastatic gastric cancer including gastroesophageal junction cancer(patients with HER2 negative and PD-L1 CPS≥5).Patiens will recevie Serplulimab plus chemotherapy ((oxaliplatin+capecitabine) as first-line treatment. After PD,patients will randomly 2:1 assigned to treatment:one group will receive Serpluimab with Paclitaxel,Apatinib;another group will receive Paclitaxel with or without Ramucirumab.All of eligible patients will receive study drug treatment until loss of clinical benefit, unacceptable toxicity, death, withdrawal of informed consent
stage one :Serplulimab 3mg/kg,d1,q2w or 4.5mg/kg,d1,q3w+oxaliplatin130mg/m2 iv.gtt d1+capecitabine 1000mg/m2 p.o.b.i.d d1~d14,q3w
stage two:Serplulimab 3mg/kg,d1,q2w or 4.5mg/kg,d1,q3w+Apatinib 250mg/qd+Paclitaxel 135~175mg/m2 iv.gtt,d1,q3w
Paclitaxel 135~175mg/m2 iv.gtt,d1,q3w±Ramucirumab 8mg/kg,d1,q2w
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| continuation of Serplulimab plus chemotherapy after first progression | Experimental | Serplulimab+Paclitaxel+Apatinib Paclitaxel±Ramucirumab |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Serplulimab+Paclitaxel+Apatinib | Drug | Immunotherapy+chemotherapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| 6-month PFS% | Progression-free survival by IRRC assessment per RECIST 1.1 | The Percent of patinets after first progression until disease progression in 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| OS | Overall survival | From the date of first dose unitl the date of death from any cause,assessed up to 2 years ] |
| PFS2 | Progression-free survival by IRRC assessment per RECIST 1.1 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tianjin Medical University Cancer Institute and Hospital | Recruiting | Tianjin | Tianjin Municipality | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Serplulimab
Not provided
Not provided
Not provided
Not provided
| Paclitaxel±Ramucirumab | Drug | chemotherapy±Targeted therapy |
|
|
| From date of randomization until the date of second-line treatment progression or date of death from any cause, whichever came first |
| PFS1 | Progression-free survival by IRRC assessment per RECIST 1.1 | From date of randomization until the date of first documented progressionor date of death from any cause, whichever came first |
| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
Not provided
Not provided