OncoMatch/Clinical Trials/NCT06383559
Safety and Efficacy of XELOX Combined With Sintilimab and Lenvatinib in Advanced AFP-positive Gastric Cancer Patients
Is NCT06383559 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Lenvatinib and Sintilimab for gastric cancer.
Treatment: Lenvatinib and Sintilimab — This is a multi-center, prospective, open label phase 2 study evaluating the safety and efficacy of standard first-line chemotherapy XELOX regimen combined with Sintilimab (anti-PD-1 antibody) and Lenvatinib in the treatment of advanced AFP-positive gastric cancer. This study was conducted in the Department of Gastrointestinal Medical Oncology, Tianjin Medical University Cancer Institute and Hospital. Previous phase 1 dose escalation study (TJMUCH-GI-GC002) has demonstrated that such combinational pattern was well tolerated with promising efficacy. 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 XELOX regimen combined with Sintilimab plus Lenvatinib every 3 weeks until disease progression or intolerable adverse reactions or death. The treatment regimen is XELOX chemotherapy (oxaliplatin 130mg/ m2, d1, capecitabine 850-1250 mg/m2, bid, d1-14, every 3 weeks) in combination with Sintilimab (\>=60kg, 200 mg; \<60kg, 3mg/kg; intravenous infusion, every 3 weeks) plus Lenvatinib (determined from previous phase 1 study, 16mg, orally once a day). Patients received regular and periodic reviews, with imaging evaluations every 6 weeks. Safety will be evaluated by AE and laboratory tests.
Check if I qualifyExtracted eligibility criteria
Cancer type
Gastric Cancer
Biomarker criteria
Required: HER2 (ERBB2) negative
HER-2 negative
Disease stage
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: Lenvatinib (Lenvatinib)
Patients who have previously been treated with Lenvatinib
Cannot have received: anti-PD-1 therapy
Patients who have previously been treated with any anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs
Cannot have received: anti-PD-L1 therapy
Patients who have previously been treated with any anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs
Cannot have received: anti-PD-L2 therapy
Patients who have previously been treated with any anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs
Lab requirements
Blood counts
Neutrophil count ≥ 1.2 × 10^9/L, Platelet count ≥ 100 × 10^9/L, Hemoglobin (HB) ≥ 80g/L, INR ≤ 1.5
Kidney function
Creatinine ≤ 1.5 times upper limit of normal, Urinary protein: 2+ or less, UPC ratio < 3.5, or 24-hour urinary protein ≤ 3500mg
Liver function
Total bilirubin ≤ 1.5mg/dl, AST and ALT ≤ 100 IU/L. If the abnormal liver function is due to liver metastasis, AST and ALT should be ≤ 200 IU/L
Normal organ function: Neutrophil count ≥ 1.2 × 10^9/L, Platelet count ≥ 100 × 10^9/L, Hemoglobin (HB) ≥ 80g/L, Total bilirubin ≤ 1.5mg/dl, AST and ALT ≤ 100 IU/L. If the abnormal liver function is due to liver metastasis, AST and ALT should be ≤ 200 IU/L, Creatinine ≤ 1.5 times upper limit of normal, INR ≤ 1.5; Urinary protein: 2+ or less, UPC ratio < 3.5, or 24-hour urinary protein ≤ 3500mg
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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