Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Zhangjiagang First People's Hospital | OTHER |
Not provided
Not provided
Not provided
Not provided
The objective is to investigate the efficacy and safety of Envafolimab combined with chemotherapy in the treatment of metastatic or recurrent gastric adenocarcinoma.
Envafolimab indication: Envafolimab is the world's first subcutaneous injection of PD-L1 monoclonal antibody.Suitable for adult patients with advanced solid tumors with unresectable or metastatic microsatellite highly unstable (MSI-H) or mismatch repair gene defects (dMMR).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| envafolimab plus chemotherapy | Experimental | Envafolimab:300mg,sc,d1,Q3W; Chemotherapy:SOX(Oxaliplatin,130mg/m2, iv,d1,Q3W + S-1,40mg/m2, op,bid,d1-14,Q3W). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Envafolimab | Drug | 300mg,sc,d1,Q3W |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| ORR | Objective response rate | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| PFS | Progression Free Survival | 6 months |
| OS | Overall Survival | 12 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Liangjun Zhu | Contact | +8613905199123 | zhulj98@foxmail.com | |
| Sheng Li | Contact | +8613770768636 | lihsh198@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Liangjun Zhu | Jiangsu Cancer Institute & Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jiangsu Cancer Institute & Hospital | Recruiting | Nanjing | Jiangsu | 210009 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D009385 | Neoplastic Processes |
| D009369 | Neoplasms |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C000718749 | envafolimab |
| D007167 | Immunotherapy |
| D000077150 | Oxaliplatin |
| D004358 | Drug Therapy |
| C079198 | S 1 (combination) |
| ID | Term |
|---|---|
| D056747 | Immunomodulation |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
| D056831 | Coordination Complexes |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Oxaliplatin | Drug | 130mg/m2, iv,d1,Q3W |
|
|
| S1 | Drug | 40mg/m2, op,bid,d1-14,Q3W |
|
|
| DCR |
Disease Control Rate |
| 9 months |
| DOR | Duration of Response | 12 months |
| AEs | Percentage of participants experiencing grade 3-5 adverse events | 12 months |
| Qualify of Life | Based on Quality of Life Questionnare-Core 30, evaluate the quality of life of patients | 12 months |
| D009930 |
| Organic Chemicals |