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 (Jun 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
Treatments studied
Other
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.
Frequently asked questions
Is NCT06157996 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Does this trial require CD274?
Yes, CD274 positive is a required biomarker for enrollment.
Are patients with ERBB2 alterations eligible?
No. ERBB2 positive is an exclusion criterion.
What disease stage is eligible?
Stage IV is required (metastatic disease required).
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages