Gastric Cancer (GC) Gastroesophageal Junction Cancer (GEJ)
Conditions
Brief summary
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
Detailed description
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
Interventions
DRUGSerplulimab+Paclitaxel+Apatinib
Immunotherapy+chemotherapy
DRUGPaclitaxel±Ramucirumab
chemotherapy±Targeted therapy
Sponsors
Tianjin Medical University Cancer Institute and Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Serplulimab
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Volunteer to participate in this clinical study; completely understand and know this study as well as sign the informed consent form (ICF); be willing to follow and be able to complete all study procedures; 2. Age ≥ 18 years and ≤ 75 years when ICF is signed; 3. Unresectable locally advanced, or metastatic gastric cancer including gastroesophageal junction cancer, and histopathologically confirmed diagnosis of adenocarcinoma; 4. never received systemic anti-tumor drug therapy before； 5. HER2 negative and PD-L1 CPS≥5; 6. Measurable lesion according to RECIST v1.1 by IRRC; 7. ECOG score 0-1;
Exclusion criteria
1. Has other active malignancies within 5 years before the first administration of the study drug; 2. Plan to or have previously received organ or bone marrow transplantation; 3. Uncontrollable pleural effusion, pericardial effusion or ascites requiring repeated drainage; 4. Have received any research drugs within 14 days before the first use of the study drugs.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 6-month PFS% | The Percent of patinets after first progression until disease progression in 6 months | Progression-free survival by IRRC assessment per RECIST 1.1 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| OS | From the date of first dose unitl the date of death from any cause，assessed up to 2 years ] | Overall survival |
| PFS2 | From date of randomization until the date of second-line treatment progression or date of death from any cause, whichever came first | Progression-free survival by IRRC assessment per RECIST 1.1 |
| PFS1 | From date of randomization until the date of first documented progressionor date of death from any cause, whichever came first | Progression-free survival by IRRC assessment per RECIST 1.1 |
Countries
China
Outcome results
None listed