Evaluate the objective response rate (ORR) of the combination of candenizumab, lenvatinib, and SOX regimen for the treatment of HER2 negative advanced gastric or gastroesophageal junction adenocarcinoma patients
Age: 18 years ≤ Age ≤ 75 years;
Locally advanced or metastatic HER2 negative gastric or gastroesophageal junction adenocarcinoma confirmed by histopathology or cytology that cannot be resected;
Has not received radiotherapy, chemotherapy, targeted therapy, or immunotherapy as the primary treatment option for advanced or metastatic diseases in the past; Participants with gastric or gastroesophageal junction adenocarcinoma who have previously received adjuvant or neoadjuvant chemotherapy, radiotherapy, and/or radiochemotherapy are eligible for enrollment as long as the last administration of the previous protocol occurred at least 6 months prior to randomization.
At least one measurable lesion #see Appendix 2#;
If a subject meets any of the following conditions, they will not be allowed to enter this study
Patients with allergies or suspected allergies to research drugs or similar drugs;
Suffering from other malignant tumors within the past 5 years, excluding skin basal cell or squamous cell carcinoma after radical surgery, or cervical carcinoma in situ;
Received live vaccine within 4 weeks prior to enrollment or possibly during the study period;
Single group
Combination of Cardonizumab with Lenvatinib and SOX regimen
DrugPhase 1: Conduct a ramp up test on the dosage of lenvatinib according to the traditional 3+3 design; Phase 2: 6 cycles of treatment with candenizumab+lenvatinib+SOX regimen (Q3W); For patients who have not progressed, they will enter the third stage of maintenance treatment. Phase 3: Maintenance therapy with candenizumab, lenvatinib, and tigio (Q3W).
ORR
Overall Response Rate
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