This is a single-arm, open-label, multi-center clinical study to evaluate the efficacy and safety of PD-1/CTLA-4 bispecific cadonilimab in combination with oxaliplatin/capecitabine (CapeOX) in the first-line treatment of advanced gastric cancer or gastro-esophageal junction adenocarcinoma with a high tumor microenvironment score (TMEscore). The study plans to enroll 50 patients to receive cadonilimab 100mg/kg, iv, q3w + CapeOX (oxaliplatin 130mg/m2, vd, d1 + capecitabine 1000mg/m2, po, bid, D1-14, q3w, with 3 weeks as a cycle and a maximum of 8 cycles of treatment. Then the maintenance treatment phase with cadonilimab ± capecitabine is entered, and the specific dosage is the same as the treatment period. Effectiveness is assessed every 9 weeks (±7 days) using RECISIT 1.1 until disease recurrence, metastasis, death, or loss of follow-up. The primary endpoint of this study was PFS, and secondary endpoints were OS, ORR, and safety.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Cadonilimab plus oxaliplatin/capecitabine (CapeOX) chemotherapy as first-line treatment in patients with advanced gastric cancer or gastro-esophageal junction adenocarcinoma: Cadonilimab 10mg/kg, iv, q3w + oxaliplatin 130mg/m2, vd, d1 + capecitabine 1000mg/m2, po, bid, d1-d4, q3w (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.
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, China
Progression-free Survival (PFS)
Defined as the time between the onset of PD or death when a patient first receives the study drug, whichever occurs first.
Time frame: 3 years
Overall survival (OS)
Defined as the time between the patient's first receipt of the study drug to death.
Time frame: 3 years
Objective Response Rate (ORR)
Defined as the proportion of patients who achieved complete response (CR) or partial response (PR).
Time frame: 3 years
Safety
The occurrence of various AEs, including SAEs, will be monitored based on changes in various indicators such as vital signs, physical examination, 12-lead electrocardiogram (ECG), laboratory tests, etc. AEs will be graded for severity according to NCI CTCAE 5.0.
Time frame: 3 years
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