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A Single-arm, Open Phase II Trial of CAPOX Combined With Bevacizumab Combined With Tislelizumab in First-line Treatment of PDL1 CPS < 5 Locally Advanced or Metastati 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 + tislelizumab 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 + tislelizumab 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first year of treatment to assess efficacy, and every 3 cycles after 1 year until treatment ends, informed consent is withdrawn, or death.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Chinese PLA General Hospital
Beijing, China
Start Date
April 25, 2022
Primary Completion Date
January 20, 2025
Completion Date
January 20, 2025
Last Updated
March 18, 2025
32
ACTUAL participants
CAPOX combined with bevacizumab and Tislelizumab
DRUG
Lead Sponsor
Chinese PLA General Hospital
Data Source & Attribution
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