Lenvatinib Plus Tislelizumab and CapeOX as First-Line Treatment for Advanced GC/GEJC With Positive PD-L1 and Low TMEscore

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 cyc

Trial Details

NCT ID
NCT06157996
Phase
PHASE2
Sponsor
Nanfang Hospital, Southern Medical University
Status
RECRUITING
Cancer Type
Gastric Cancer
Interventions
  • lenvatinib and tislelizumab plus CapeOX chemotherapy
  • tislelizumab plus CapeOX chemotherapy
Locations (sample)
  • Guangzhou, Guangdong, China|23.11667,113.25

Key Eligibility Criteria

  • Patients voluntarily participated in the study, signed the informed consent, and had good compliance;
  • Age over 18 (including 18 years old), gender is not limited;
  • Histologically and/or cytologically confirmed advanced gastric cancer or gastroesophageal junction adenocarcinoma (stage IV);
  • Tumor with PD-L1 positive and low tumor microenvironment score (TMEscore)

For full eligibility, visit ClinicalTrials.gov.

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