Gastric or gastroesophageal junction adenocarcinoma
Conditions
Interventions
Treatment group:AK104+ SOX
control group:Sintilimab+SOX
Sponsors
Lanzhou University Second Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Subjects must meet all of the following criteria to be enrolled in this study: 1. Subject Type and Disease Characteristics 1.1 Subjects must be pathologically confirmed to have HER-2 negative tumors and diagnosed as diffuse type gastric/esophagogastric junction adenocarcinoma according to the Lauren histological classification. 1.2 Subjects must have previously untreated locally advanced gastric or esophagogastric junction adenocarcinoma (staging cT2-cT4), with lymph node involvement in the N1 to N3 range, but with no evidence of metastatic disease (M0). 1.3 Patients with Siewert type 2 or 3 tumors may be included. For patients with Siewert type 1 tumors, only those planned for perioperative chemotherapy and resection are eligible for enrollment. 2. Demographic Data 2.1 Age: Male or female subjects must be aged >= 18 years and = 12 weeks. 2.3 Performance Status: Subjects' ECOG performance status score must be 0 or 1. 2.4 Male Contraceptive Requirements: Unsterilized male subjects (whose partners are of childbearing potential) must use effective contraceptive methods during sexually active periods and from the first day of study medication until 120 days after the last dose. It is recommended that female partners of male subjects also use effective contraceptive methods during this time. 2.5 Female Contraceptive Requirements: Female subjects of childbearing potential must agree to use adequate contraceptive methods during the study and for 120 days after the last dose. Decisions regarding the cessation of contraception after this point should be discussed with the attending physician. Periodic abstinence, rhythm methods, and withdrawal methods are not considered effective contraceptive methods. a. Females of childbearing potential are defined as those who have not undergone surgical sterilization (e.g., bilateral tubal ligation, bilateral oophorectomy, or hysterectomy) or who have not reached menopause (defined as 12 months without menstruation and without other medical reasons). b. Highly effective contraceptive methods must have a low failure rate (i.e., = 3.0 × 10^9/L; ANC >= 1.5 × 10^9/L; PLT >= 100 × 10^9/L; HGB >= 80 g/L. 3.2 Liver Function: Total bilirubin (TBIL) 1.5 × ULN, direct bilirubin must be 1.5 × ULN, creatinine clearance (CrCl) >= 60 mL/min. 3.4 Coagulation Function: INR <= 1.5 × ULN, APTT <= 1.5 × ULN. 3.5 Cardiac Function: Cardiac function assessed by ECG and color Doppler ultrasound, with no history of myo
Exclusion criteria
Exclusion criteria: Patients who meet any of the following criteria shall not be included in this study: 1. Medical Conditions 1.1 History of pneumonia (non-infectious) requiring corticosteroid treatment, or current pneumonia. 1.2 Known to have other malignant tumors that are currently progressing, or malignant tumors that required active treatment within the past 5 years (except for skin basal cell carcinoma, squamous cell carcinoma, or carcinoma in situ that has undergone potentially curative treatment). 1.3 Active infections requiring systemic treatment. 1.4 Active autoimmune diseases requiring systemic treatment within the past 2 years. (Note: Subjects with the following conditions are not excluded: vitiligo, alopecia, Graves’ disease, type 1 diabetes, hypothyroidism requiring only hormone replacement therapy (with stable dosage for 4 weeks prior to study treatment and no need for adjustment), psoriasis or eczema that do not require systemic treatment in the past 2 years, or diseases that are not expected to relapse without external triggering factors.) 1.5 Complications requiring systemic corticosteroids (e.g., prednisone >10 mg daily) or other immunosuppressive drugs, which must not have been used within 14 days prior to the first dose. (Alternative therapies such as thyroid hormone, insulin, or physiological corticosteroid replacement therapy required due to adrenal or pituitary insufficiency are allowed.) 1.6 History of primary immunodeficiency. 1.7 Administration of live vaccines or other immuno-activating antitumor treatments (such as interferons, interleukins, thymosin, or immunotherapy) within 30 days prior to the first dose of the study drug. 1.8 Known history of active tuberculosis. 1.9 Known history of organ transplantation or allogeneic hematopoietic stem cell transplantation. 1.10 Known history of severe allergy or allergic reactions to cadonilimab or sintilimab, or to the study chemotherapy agents and their components. 1.11 Presence of any cardiovascular or cerebrovascular diseases or related risk factors: a. Secondary or higher-grade myocardial ischemia or myocardial infarction, uncontrolled arrhythmias (including QTc interval >= 480 ms), grade 3 or 4 heart failure, or color Doppler ultrasound indicating left ventricular ejection fraction (LVEF) <50.0%. b. Stroke, transient ischemic attack, or other arterial or venous thrombosis, embolism, or ischemic events. 2. Prior/Concomitant Treatment 2.1 Subjects who have participated in other clinical trials, unless they are involved in observational, non-interventional studies, or are in the follow-up period of an interventional study (it must be ensured that the interval between the first use of AK104 and the last dose of the previous study is more than 4 weeks or more than 5 half-lives of the previous study drug). 2.2 Subjects who have received any systemic or curative antitumor treatment, including radiotherapy, chemotherapy, and targeted therapy. 2.3 Subjects who have previously received any anti-PD-1, anti-PD-L1, anti-CTLA-4 antibodies, or other antibodies or drugs targeting T-cell co-stimulation or checkpoint pathways, such as ICOS or agonists (e.g., CD40, CD137, GITR, OX40, etc.). 3. Other Exclusion Criteria 3.1 Patients diagnosed with HER-2 positive tumors will be excluded. 3.2 Patients unable to provide tumor samples and blood samples. 3.3 Pregnant or breastfeeding patients, as well as patients of childbearing potential who plan to become pregnant within 5 months after the study ends. Fe
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological complete response rate;Median Disease-Free Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Major pathological response rate;Objective Response Rate;Disease Control Rate;3-year Event-Free Survival Rate;3-year Overall Survival Rate;3-year Disease-Free Survival Rate;Duration of Remission;Safety (Treatment-Related Adverse Events);R0 Resection Rate;Downstaging Rate of T Stage, N Stage, and TNM Stage;Surgical-Related Complications;Median Overall Survival;Median Event-Free Survival; | — |
Countries
China
Contacts
Public ContactZuoyi Jiao
Lanzhou University Second Hospital
Outcome results
None listed