For locally advanced esophagogastric junction and gastric cancer, neoadjuvant chemotherapy can downstage T and N stage,treated distant micrometastases early , and finally improve the long-term survival. Combination of perioperative PD-1 antibody and chemotherapy for locally advanced esophagogastric junction and gastric cancer could be a novel therapy to increase response rate and reduce recurrence rate.Cadonilimab, a tetravalent bispecific antibody targeting PD-1 and CTLA-4, is designed to retain the efficacy benefit of combination of PD-1 and CTLA-4 and improve on the safety profile of the combination therapy. The aim of this study is to evaluate the efficacy and safety of cadonilimab Plus Chemotherapy for Locally Advanced Esophagogastric Junction and Gastric Cancer.
Confirmed gastric and gastroesophageal junction adenocarcinoma by Gastroscopic biopsy histopathological examination.
Imaging (CT/MRI) and diagnostic laparoscopy confirmed at the stage of cT3-4aN1-3M0(AJCC 8th) .
Physical condition and organ function allow for for larger abdominal surgery.
Adequate haematological, renal and liver function.
Patients who have HER2 positive confiemed with IHC3+ or IHC2+ and FISH positive.
Confirmed at stage IV (AJCC 8th) or unresectable by investigator.
Prior chemotherapy, radiotherapy, surgery immunotherapy or molecular targeted therapy for gastric cancer.
Patients are allergic to study medication and its ingredients.
Single group
Cadonilimab
Drug10mg/kg intravenous (IV) every 3 weeks ;
Oxaliplatin
Drug130mg/m², iv drip for 2h, d1, q3w;
Capecitabine
Drug1000mg/m² po, Bid, d1-14, q3w ;
Pathologic complete remission rate (pCR)
Pathological complete response (pCR) rate is defined as the proportion of participants whose tumor in the stomach and lymph node completely disappeared, as determined by a pathologist.
Major pathologic response，MPR
Major pathological response (MPR) rate is defined as the proportion of participants whose percentage of residual tumor in the stomach and lymph node decreased to \< 10%, as determined by a pathologist
R0 resection rate
Rate of microscopically margin-negative resection
Objective Response Rate (ORR)
defined as the percentage of participants who achieve a best overall response of complete response or partial response assessed according to mRECIST v1.1 for assessment of response in malignant pleural mesothelioma.
Disease Control Rate (DCR)
defined as the percentage of participants who achieve a best overall response of complete response, partial response, or stable disease assessed according to mRECIST v1.1 for assessment of response in malignant pleural mesothelioma.
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