This study was designed to explore the efficacy and safety of fruquintinib combined with PD-1 inhibitors as first-line maintenance therapy for advanced HER-2 Negative Gastric Cancer.
Voluntarily signed the informed consent and had good compliance;
Age ≥18 years, Eastern Cooperative Oncology Group (ECOG) score 0-1, and expected survival time ≥12 months;
Histologically or cytologically unresectable, locally advanced, recurrent or metastatic gastric or gastroesophageal junction adenocarcinoma;
He had not received previous systemic chemotherapy for unresectable, locally advanced, recurrent, or metastatic gastric or gastroesophageal junction adenocarcinoma;
Participated in other drug clinical trials within 4 weeks before enrollment;
Have had other malignancies within the past 5 years, except cured basal cell carcinoma of the skin, papillary carcinoma of the thyroid, superficial bladder, carcinoma in situ of the breast, and carcinoma in situ of the cervix ;
History of severe heart disease, such as symptomatic congestive heart failure (CHF) ≥ grade 2 (NCI-CTCAE 5.0), heart failure ≥ grade 2 New York Heart Association (NYHA), transmural myocardial infarction, unstable angina, poorly controlled arrhythmia, etc.
Hypertension poorly controlled by two antihypertensive drugs (systolic blood pressure ≥160mmHg or diastolic blood pressure ≥100mmHg) and type 2 diabetes uncontrolled by antidiabetic treatment (fasting blood glucose ≥8.9mmol/L);
Single group
Initial treatment: PD-1+ Oxaliplatin-based chemotherapy (CAPOX/SOX/FOLFOX）
DrugCAPOX/SOX (each cycle is 21 days): Oxaliplatin 130mg/m2, ivgtt, D1; Capecitabine 1000 mg/m2, po, bid, D1-14 or S-1: 40-60mg according to BSA, bid, D1-14. FOLFOX (each cycle is 14 days): Oxaliplatin 85mg/m2, ivgtt, D1, Q2W; 5-Fluorouracil: 400mg/m2, D1, followed by 2400 mg/m2 as a continuous IV infusion over 46 hours; Leucovorin: 400mg/m2, iv, D1. PD-1 monoclonal antibody: Nivolumab 360mg/3 weeks or 240mg /2 weeks, iv, D1; If weight ≥60 kg, Sintilimab 200mg/3 weeks; if weight \< 60 kg, Sintilimab 3mg/kg/3 weeks, iv, D1; Tislelizumab 200mg/3 weeks, iv, D1; Pembrolizumab 200mg/3 weeks, iv, D1;
Maintenance treatment (after 3 months): fruquintinib+PD-1
DrugAfter 3 months (12 weeks) of initial treatment with oxaliplatin-based chemotherapy combined with PD-1 monoclonal antibody, those with complete response (CR), partial response (PR) or stable disease (SD) assessed by imaging evaluation continued to receive maintenance treatment with furoquininib and PD-1 monoclonal antibody. Fruquintinib 3 mg/d, qd po, D1-21, Q4W; PD-1 monoclonal antibody is repeated as initial treatment until the disease progresses or unacceptable toxicity.
One-year progression-free survival rate
The proportion of patients who remain alive and free from disease progression for at least 12 months after initiating treatment.
One-year overall survival rate
The proportion of patients who remain alive for at least 12 months after initiating treatment.
Two-year overall survival rate:
The proportion of patients who remain alive for at least 24 months after initiating treatment.
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