Gastric Cancer Clinical Trial
Official title:
Efficacy and Safety of Peri-operative Sintilimab in Combination With SOX in Resectable Locally Advanced Gastric Cancer: a Multiple-center Open-label Randomized Phase II Trial.
To evaluate efficacy and safety of peri-operative sintilimab in combination with SOX in resectable locally advanced gastric or gastroesophageal junction adenocarcinoma
Status | Recruiting |
Enrollment | 210 |
Est. completion date | June 21, 2024 |
Est. primary completion date | June 21, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: - Male or female, 18 years old = age = 75 years old - ECOG PS score 0-1 - Treatment naive patients diagnosed as gastric adenocarcinoma or gastroesophageal junction adenocarcinoma by histopathology - No known HER2-positive status; - Clinical stage ?, ? (T1-4a N+ M0, T3-4a N0 M0, AJCC 8th) - The research center and the surgeon can complete D2 radical gastrectomy - Physical condition and organ function allow for larger abdominal surgery - Sufficient organ and bone marrow function, which is defined as follows: 1. Blood routine: absolute neutrophil count (ANC)=1.5×109/L; platelet count (PLT)=100×109/L; hemoglobin content (HGB)=9.0 g/dL. 2. Liver function: Patients without liver metastasis require serum total bilirubin (TBIL) =1.5×upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =2.5 ×ULN; 3. Renal function: Creatinine clearance rate (Ccr) =50 mL/min (calculated by Cockcroft/Gault formula): 1. Female: Ccr= (140-years old) x weight (kg) x 0.85/(72 x serum creatinine (mg/dL)) 2. Male: Ccr= (140-years old) x weight (kg) x 1.00/(72 x serum creatinine (mg/dL)) 4. The coagulation function is adequate, defined as the international normalized ratio (INR) or prothrombin time (PT) = 1.5 times ULN; if the subject is receiving anticoagulation therapy, as long as the PT is within the proposed range of anticoagulation drugs - LVEF=50%; - Agree and be able to comply with the plan during the research period; - Provide written informed consent before entering the study screening, and the patient has understood that participants can withdraw from the study at any time during the study without any loss; Exclusion Criteria: - Complicated with upper gastrointestinal obstruction/bleeding or abnormal digestive function or malabsorption syndrome; - Complicated with severe uncontrolled concurrent infection or other severe uncontrolled concomitant disease, moderate or severe renal injury; - Received previous anti-tumor therapy, including chemotherapy, radiotherapy, targeted therapy or immunotherapy, etc.; - Suffered from other malignant tumors in the past 5 years (except basal cell or squamous cell carcinoma, superficial bladder cancer, cervical cancer in situ or breast cancer); - Uncontrollable pleural effusion, pericardial effusion or ascites; - Suffered from severe cardiovascular disease within 12 months before enrollment, such as symptomatic coronary heart disease, congestive heart failure = Grade II, uncontrolled arrhythmia, and myocardial infarction; - Allergic reactions to the drugs used in this study; - Use steroids or other systemic immunosuppressive therapies 14 days before enrollment; - Patients who received study drug treatment within 4 weeks before enrollment (participate in other clinical trials); - Active autoimmune diseases; - History of primary immunodeficiency; - Have used immunosuppressive drugs within 4 weeks before the first dose of study treatment, excluding nasal spray, inhaled or other local glucocorticoids or physiological doses of systemic glucocorticoids (that is, no more than 10 mg/day Pred nisone or other glucocorticoids in equivalent doses), or use hormones to prevent allergy to contrast agents; - Within 4 weeks before the first dose of study treatment or plan to receive live attenuated vaccine during the study period; - Known to have active tuberculosis; - Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation; - HIV antibody positive, active hepatitis B or C (HBV, HCV); - Pregnant or lactating women |
Country | Name | City | State |
---|---|---|---|
China | Tianjin Medical University Cancer Institute & Hospital | Tianjin | Tianjin |
Lead Sponsor | Collaborator |
---|---|
Tianjin Medical University Cancer Institute and Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pathological complete response (pCR) rate | 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. | up to 8 weeks after surgery | |
Secondary | Tumor down-staging rate | Tumor down-staging is defined as any stage reduction between clinical and pathologic stage | up to 8 weeks after surgery | |
Secondary | Major pathological response (MPR) rate | 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. | up to 8 weeks after surgery | |
Secondary | 3 years disease-free survival (DFS) rate | 3 years disease-free survival (DFS) rate is defined as proportion of participants who have no recurrence or metastasis after 3 years of radical treatment | up to 4 years | |
Secondary | 5 years overall survival (OS) rate | 5 years overall survival (OS) rate is defined as proportion of participants who survived 5 years after radical treatment | up to 6 years | |
Secondary | Adverse event | All grades of adverse events, all grades of treatment related adverse events, serious of adverse events | up to 30 days after last treatment administration | |
Secondary | Overall response rate ( ORR) | Overall response rate ( ORR) is defined as proportion of participants who have a best response of CR or PR | up to 30 days after last preoperative treatment administration | |
Secondary | Disease Control Rate (DCR) | Disease Control Rate (DCR) is defined as proportion of participants who have a best response of CR?PR or SD | up to 30 days after last preoperative treatment administration |
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