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Lenvatinib Plus Tislelizumab and CapeOX as First-Line Treatment for Advanced GC/GEJC With Positive PD-L1 and Low TMEscore
Sponsor: Nanfang Hospital, Southern Medical University
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.
Official title: Tislelizumab Plus CapeOX ± Lenvatinib as First-Line Treatment for Advanced GC/GEJC With Positive PD-L1 and Low TMEscore: A Multi-center, Prospective, Phase II Study
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
92
Start Date
2024-06-01
Completion Date
2026-08
Last Updated
2025-05-30
Healthy Volunteers
No
Conditions
Interventions
lenvatinib and tislelizumab plus CapeOX chemotherapy
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.
tislelizumab plus CapeOX chemotherapy
Tislelizumab 200mg, iv, d1+ oxaliplatin 130mg/m2, iv, d1+ capecitabine 1000mg/m2, bid po, D1-14, q3w regimen are received, respectively (3 weeks as a cycle, a maximum of 8 cycles of treatment). Then the maintenance treatment phase with tislelizumab is entered, and the specific dosage is the same as the treatment period.
Locations (1)
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, China