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.
Male or female patients ≥18 years old;
Patients with advanced / metastatic gastric cancer diagnosed by histopathology, without liver like differentiation, HER-2 negative, serum AFP ≥ 2xULN or AFP positive by the IHC staining;
No previous palliative systemic treatment;
There are measurable metastatic lesions according to RECIST version 1.1;
Patients who received surgery and radiotherapy within 2 weeks before enrollment;
Patients who have previously been treated with Apatinib or any anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs;
Patients with uncontrollable hypertension (systolic blood pressure ≥ 160mmHg and diastolic blood pressure ≥ 90mmHg);
Patients with acute coronary syndrome (including myocardial infarction and unstable angina) who had undergone coronary angioplasty within 6 months before enrollment;
Single group
SOX regimen combined with Sintilimab and Apatinib
DrugPatients 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).
ORR
the rate of patients with PR and CR
OS
The time from the beginning of treatment to the time when the patient dies from any cause
PFS
The time from the beginning of treatment to the time when the disease progresses or the patient dies from any cause
AE
Safety will be evaluated by AE
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