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This is a multi-center, prospective, open label phase II study evaluating the safety and efficacy of standard first-line chemotherapy SOX regimen combined with Sintilimab (anti-PD-1 antibody) and Apatinib in the treatment of advanced AFP-positive gastric cancer. This study was conducted in the Department of Anhui Provincial Cancer Hospital. In this study, patients with AFP-positive and HER-2-negative advanced gastric cancer who had not received palliative systematic treatment in the past will be enrolled. Patients who met the inclusion criteria were treated with SOX regimen combined with Sintilimab plus Apatinib every 3 weeks(4 cycles) followed by sintilimab+apatinib until disease progression or intolerable adverse reactions or death(up to 24 months).Patients received regular and periodic reviews, with imaging evaluations every 6 weeks. Safety will be evaluated by AE and laboratory tests.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental arm | Experimental | Drug: Apatinib and Sintilimab SOX regimen combined with Sintilimab and Apatinib |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SOX regimen combined with Sintilimab and Apatinib | Drug | Patients who met the inclusion criteria were treated with SOX regimen combined with Sintilimab plus Apatinib every 3 weeks(4 cycles) followed by sintilimab+apatinib until disease progression or intolerable adverse reactions or death(up to 24 months). |
| Measure | Description | Time Frame |
|---|---|---|
| ORR | the rate of patients with PR and CR | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| OS | The time from the beginning of treatment to the time when the patient dies from any cause | 24 months |
| PFS | The time from the beginning of treatment to the time when the disease progresses or the patient dies from any cause |
| Measure | Description | Time Frame |
|---|---|---|
| AE | Safety will be evaluated by AE | 24 months |
Inclusion Criteria:
Exclusion Criteria:
14. Patients who need systemic corticosteroids (excluding temporary use for testing, prophylactic administration of allergic reactions or reduction of swelling associated with radiotherapy) or immunosuppressants, or patients who receive such treatment within 14 days before enrollment; 15. The patient has a history of (non-infectious) pneumonia requiring steroids or has a current history of pneumonia; 16. Patients who received live vaccine < 30 days before starting trial drug treatment; The patient has serious non-healing wounds, ulcers or fractures; 17. Pregnant or lactating women; 18. The investigator determined that the patient is not suitable to be the subject of this trial; 19. Other circumstances that the investigator considers inappropriate to participate in the clinical trial.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Juan Cai | Contact | 0551-65327766 | caijuan1987@yeah.net |
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|
| 24 months |
| ID | Term |
|---|---|
| C000632826 | sintilimab |
| C553458 | apatinib |
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