Gastric cancer
Conditions
Interventions
Intervention group:Puterizumab+levatinib+oxaliplatin+SOX
Comparator group:Oxaliplatin and SOX
Sponsors
Department of Gastric Surgery, Fujian Medical University Union Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Inclusion Criteria 1. Age between 18 and 75 years 2. Histologically or cytologically confirmed unresectable advanced HER2-negative gastric or gastroesophageal junction adenocarcinoma; 3. No prior chemotherapy, radiotherapy, targeted therapy, or immunotherapy. Patients who had previously received adjuvant or neoadjuvant chemotherapy, radiotherapy, and/or chemoradiotherapy for gastric or gastroesophageal junction adenocarcinoma were eligible provided that the last dose of prior treatment was administered at least 6 months before randomization; 4. At least one measurable lesion (see Appendix 2); 5. Eastern Cooperative Oncology Group performance status (ECOG PS) of 0–1 (see Appendix 4); 6. Estimated life expectancy of more than 3 months; 7. Adequate major organ function, defined as meeting the following criteria: 7.1 Hematologic parameters (no blood transfusion within 14 days prior to assessment): 7.1.1 Hemoglobin >= 80 g/L. 7.1.2 White blood cell count >= 3.0 × 10^9/L. 7.1.3 Absolute neutrophil count >= 1.5 × 10^9/L. 7.1.4 Platelet count >= 100 × 10^9/L. 7.2 Biochemical parameters: 7.2.1 Total bilirubin 60 mL/min calculated using the Cockcroft–Gault formula; 8. Women of childbearing potential must have a negative serum pregnancy test within 7 days prior to enrollment and agree to use effective contraception during the study and for 8 weeks after the last administration of the study drug. Male participants must have undergone surgical sterilization or agree to use effective contraception during the study and for 8 weeks after the last administration of the study drug; 9. No participation in other clinical studies before or during the study treatment period; All participants voluntarily enrolled in the study, provided written informed consent, demonstrated good compliance, and agreed to adhere to follow-up requirements.
Exclusion criteria
Exclusion criteria: Exclusion Criteria 1. Known or suspected hypersensitivity or allergy to the study drugs or drugs of the same class; 2. History of other malignancies within the past 5 years, except for adequately treated basal cell carcinoma or squamous cell carcinoma of the skin, or carcinoma in situ of the cervix; 3. Current participation in an interventional clinical study, or receipt of other antitumor drug treatment for gastric malignancies within 4 weeks prior to the first administration of the study drug; 4. Receipt of systemic treatment with traditional Chinese medicines with antitumor indications or drugs with immunomodulatory effects (including thymosin, interferon, and interleukins, except for local use to control pleural effusion) within 2 weeks prior to the first administration of the study drug; 5. Prior treatment with any of the following therapies: anti-PD-1, anti-PD-L1, or anti-PD-L2 agents, or agents targeting other stimulatory or inhibitory T-cell receptors (including but not limited to CTLA-4, OX-40, and CD137), or prior chemotherapy (including but not limited to S-1); 6. Receipt of live vaccines within 4 weeks prior to enrollment or planned receipt of live vaccines during the study period; Note: Injectable inactivated influenza vaccines for seasonal influenza were permitted within 4 weeks prior to the first dose; intranasal live attenuated influenza vaccines were not permitted; 7. History of active autoimmune disease requiring systemic treatment (e.g., disease-modifying agents, corticosteroids, or immunosuppressive drugs) within 2 years prior to the first administration of the study drug. Replacement therapies (e.g., thyroxine, insulin, or physiological doses of corticosteroids for adrenal or pituitary insufficiency) were not considered systemic treatment; 8. Prior allogeneic bone marrow transplantation or solid organ transplantation; 9. Presence of any disease or condition that may affect drug absorption, or inability to take oral medications; 10. Uncontrolled hypertension despite medical treatment, defined as systolic blood pressure >= 150 mmHg and/or diastolic blood pressure = 100 mmHg after treatment with a single antihypertensive agent, or requiring two or more antihypertensive medications to control blood pressure; 11. Urinalysis showing proteinuria >= 2+, with 24-hour urinary protein excretion > 1.0 g; 12. Active gastrointestinal diseases such as gastric or duodenal ulcers, ulcerative colitis, or presence of unresected tumors with active bleeding, or any other condition considered by the investigator to pose a risk of gastrointestinal bleeding or perforation; 13. Evidence or history of significant bleeding tendency within 3 months prior to enrollment (bleeding > 30 mL within 3 months, hematemesis, melena, or hematochezia), hemoptysis (> 5 mL of fresh blood within 4 weeks), or thromboembolic events within 12 months (including stroke and/or transient ischemic attack); 14. Clinically significant cardiovascular disease, including but not limited to acute myocardial infarction, severe or unstable angina, or coronary artery bypass grafting within 6 months prior to enrollment; congestive heart failure with New York Heart Association (NYHA) class > II; ventricular arrhythmias requiring medical treatment; or electrocardiogram (ECG) showing a corrected QT interval (QTc) >= 480 ms; 15. Active or uncontrolled severe infection (infection grade >= 2 according to CTCAE); 16. Known human immunodeficiency virus (HIV) infecti
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Progression-free survival;Duration of response;Incidence of adverse events (AEs) ;Serious adverse events (SAEs);Quality of life (QoL) ; | — |
Countries
China
Contacts
Public ContactChangming Huang
Fujian Medical University Union Hospital
Outcome results
None listed