Lenvatinib Plus Tislelizumab and CapeOX as First-Line Treatment for Advanced GC/GEJC With Positive PD-L1 and Low TMEscore
Status:
Recruiting
Trial end date:
2026-08-01
Target enrollment:
Participant gender:
Summary
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.