Gastric cancer
Conditions
Interventions
Treatment Group:The neoadjuvant treatment regimen of cadonilimab (AK104) combined with SOX was used preoperatively for 4 cycles. The specific drug regimen was as follows: (1) SOX regimen: S-1 40-60 mg
oxaliplatin 130 mg / m2 iv drip for 2h, d1, q3w
(2) Cadonilimab (AK104) drug regimen: based on the results of the COMPASSION-03 and AK104-201 study, the recommended dose of 10 mg/kg, q3w, according to the patient s tolerance level may be appropriat
Sponsors
Department of General Surgery, The First Medical Center, Chinese PLA General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 90 Years
Inclusion criteria
Inclusion criteria: ? Patients with clinically and pathologically confirmed locally progressive (clinical stage: cT2-4aN0-3M0) adenocarcinoma of the upper stomach (upper 1/3 of the stomach) or adenocarcinoma of the gastroesophageal junction, and the staging criteria should refer to the 8th edition of the AJCC guidelines; ? Age: age =18 years; ? Have an image-assessable lesion according to RECIST 1.1 criteria; ? Immunohistochemistry results suggesting non-Her-2 positivity; ? ASA score = grade III; ? Laboratory tests meet the following conditions: peripheral blood hemoglobin (Hb) =90 g/L, absolute neutrophil count =3×109/L, platelet count (PLT) =100×109/L, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =2.5 times the upper limit of normal (ULN), total bilirubin =1.5×ULN, and serum creatinine (SCr) =1.5×ULN. SCr) =1.5×ULN, serum albumin (ALB) =30 g/L; ? Eastern Cooperative Oncology Group (ECOG) score 0-1; ? Expected survival = 3 months; ? PD-L1 expression assay CPS score <1 ? Females of childbearing potential must have a negative pregnancy test and must use contraception to avoid breastfeeding during the study period and for 3 months after the last dose; male subjects must agree to use contraception during the study period and for 3 months after the last dose.
Exclusion criteria
Exclusion criteria: ? Severe mental disorder; ? Pregnant or lactating women; ? Patients with residual gastric cancer and other benign or malignant tumors of the stomach; ? Previous treatment with systemic chemotherapy, radiotherapy, PD-1 or PL-L1 receptor inhibitors, or cytotoxic T-lymphocyte-associated protein 4 (CTLA4) receptor for gastric/gastroesophageal conjunction cancer; ? Central nervous system metastases of untreated peripheral neuropathy (> grade 1, according to CTCAE 5.0 criteria); ? Developed or suspected autoimmune disease ? Infectious diseases such as hepatitis B, hepatitis C and AIDS; ? History of other malignant tumors in the last five years (except for malignant tumors for which radical tumor cure is expected after treatment, including cervical carcinoma in situ, basal or squamous cell carcinoma of the skin, limited prostate cancer, and malignant tumors with metastasis or negligible risk of death such as thyroid cancer for which the expected 5-year survival rate is >90%); ? Significant cardiovascular disease, such as NYHA classification = Class II, myocardial infarction, unstable angina prior to 3 months of enrollment; ? Systemic corticosteroids (>10 mg/d prednisone and other medications) or other systemic immunosuppressants (e.g., dexamethasone, cyclophosphamide, methotrexate, thalidomide, etc.) within 2 weeks of enrollment. Topical applications such as ocular, intra-articular, intranasal and inhaled corticosteroids are permitted; ? History of previous abdominal surgery (except laparoscopic cholecystectomy); ? Live virus vaccination within 4 weeks of enrollment; ? Persons with a known history of allergic reaction to test drugs such as cadonilimab (AK104), oxaliplatin, etc., or to murine proteins or human proteins or any of their excipient components, persons with a known history of anaphylactic diseases, or persons with an allergic constitution; ? Bleeding tendency, or significant hemoptysis or other bleeding events (e.g., gastrointestinal bleeding, bleeding gastric ulcers) within 2 months prior to initiation of study treatment, or presence of a hereditary or acquired predisposition to hemorrhage or thrombosis (e.g., hemophilia, coagulation disorders, thrombocytopenia, etc.) or current/long-term thrombolysis or anticoagulant therapy (except aspirin =100 mg/day); ? Inappropriate for this study in the opinion of the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pCR rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| ORR rate;DCR rate;R0 resection rate;Overall complication rate at 30 days postoperatively;MPR rate;2-year Overall survival rate;2-year Disease-free survival rate; | — |
Countries
China
Contacts
Public ContactJIANXIN CUI
Department of General Surgery, The First Medical Center, Chinese PLA General Hospital
Outcome results
None listed