Advanced Gastroesophageal Adenocarcinoma Clinical Trial
Official title:
A Single-arm, Open Phase II Trial of CAPOX Combined With Bevacizumab Combined With Tirelizumab in First-line Treatment of PDL1 CPS < 5 Advanced Gastroesophageal Adenocarcinoma
his study was a single-arm, open, single-center Phase ii clinical trial to observe and evaluate the efficacy and safety of CAPOX+ bevacizumab + tirelizumab in first-line treatment of ADVANCED gastroesophageal adenocarcinoma with CPS < 5. This study targeted advanced gastric cancer patients who could not undergo radical treatment, who had not received systemic therapy before, or who had recurrence and metastasis more than 6 months after the end of adjuvant therapy. The 6-month progression-free survival (PFS) rate will be used as the primary outcome indicator, and approximately 30 subjects will be enrolled. Subject will receive CAPOX+ bevacizumab + tirelizumab continuously for a treatment cycle of 3 weeks after fully informed and signing informed consent, oxaliplatin will be stopped after 4-8 cycles, and other drugs will continue to be used until the treatment interruption event specified in the plan occurs. Post-treatment follow-up for safety and survival will continue after completion of treatment, and follow-up for tumor progression will also be conducted after completion of treatment for subjects who have not finished treatment for a cause of disease progression/death. After the subjects were enrolled in the study, safety visits were conducted for each treatment cycle D1 before medication. Imaging will be performed every 2 cycles from the first year of treatment to assess efficacy, and every 3 cycles after 1 year until treatment ends, informed consent is withdrawn, or death.
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