OncoMatch/Clinical Trials/NCT06157996
Lenvatinib Plus Tislelizumab and CapeOX as First-Line Treatment for Advanced GC/GEJC With Positive PD-L1 and Low TMEscore
Is NCT06157996 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including lenvatinib and tislelizumab plus CapeOX chemotherapy and tislelizumab plus CapeOX chemotherapy for gastric cancer.
Treatment: lenvatinib and tislelizumab plus CapeOX chemotherapy · tislelizumab plus CapeOX chemotherapy — This is a multicenter, prospective, phase II clinical study to evaluate the efficacy and safety of intensive treatment with lenvatinib plus tislelizumab and CapeOX as first-line treatment for advanced gastric cancer or gastroesophageal junction adenocarcinoma with PD-L1 positive and low TMEscore. A total of 92 subjects are randomly divided into study group and control group according to 1:1 ratio. Tislelizumab 200mg, iv, d1+ oxaliplatin 130mg/m2, iv, d1+ capecitabine 1000mg/m2, bid po, D1-14, q3w ± Lenvatinib 8mg, qd po regimen are received, respectively (3 weeks as a cycle, a maximum of 8 cycles of treatment). Then the maintenance treatment phase with tislelizumab ± lenvatinib is entered, and the specific dosage is the same as the treatment period. Effectiveness is assessed every 9 weeks (±7 days) until disease recurrence, metastasis, death, or loss of follow-up. The primary endpoint of this study was PFS, and secondary endpoints were OS, ORR, DoR, and DCR.
Check if I qualifyExtracted eligibility criteria
Cancer type
Gastric Cancer
Biomarker criteria
Required: PD-L1 (CD274) positive (PD-L1 positive)
Tumor with PD-L1 positive
Excluded: HER2 (ERBB2) positive
HER2 positive gastric cancer or gastroesophageal junction adenocarcinoma
Disease stage
Required: Stage IV
Metastatic disease required
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: anti-PD-1 therapy
Previously received therapy that targets T cell co-stimulation or checkpoint pathways, such as anti-PD-1 antibodies, anti-PD-L1 antibodies, anti-CTLA-4 antibodies, etc.
Cannot have received: anti-PD-L1 therapy
Previously received therapy that targets T cell co-stimulation or checkpoint pathways, such as anti-PD-1 antibodies, anti-PD-L1 antibodies, anti-CTLA-4 antibodies, etc.
Cannot have received: anti-CTLA-4 therapy
Previously received therapy that targets T cell co-stimulation or checkpoint pathways, such as anti-PD-1 antibodies, anti-PD-L1 antibodies, anti-CTLA-4 antibodies, etc.
Cannot have received: anti-vascular small-molecule targeted drug therapy (fuquinitinib, regofenib)
Previously received anti-vascular small-molecule targeted drug therapy, such as fuquinitinib, regofenib, etc.
Lab requirements
Blood counts
Neutrophil absolute value ≥1.5×10^9/L, platelet ≥100×10^9/L, hemoglobin ≥90g/L
Kidney function
serum creatinine ≤1.5×ULN, or creatinine clearance (CCr)≥60ml/min
Liver function
aspartate aminotransferase and glutamate aminotransferase ≤3×ULN, bilirubin ≤1.5×ULN; In case of liver metastasis, AST and ALT≤5×ULN
Cardiac function
Echocardiography showed that the left ventricular ejection fraction was less than 50%, indicating poor arrhythmia control [excluded]
Blood test (without blood transfusion within 14 days) 1) Neutrophil absolute value ≥1.5×10^9/L, platelet ≥100×10^9/L, hemoglobin ≥90g/L); 2) Liver function test (aspartate aminotransferase and glutamate aminotransferase ≤3×ULN, bilirubin ≤1.5×ULN; In case of liver metastasis, AST and ALT≤5×ULN); 3) Renal function (serum creatinine ≤1.5×ULN, or creatinine clearance (CCr)≥60ml/min); Echocardiography showed that the left ventricular ejection fraction was less than 50%, indicating poor arrhythmia control [excluded]
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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