gastric cancer
Conditions
Interventions
Experimental group:Oral administration of propranolol
Sponsors
Anhui Provincial Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Subjects eligible for inclusion in this study must meet all of the following criteria: 1. Sign a written informed consent before implementing any trial-related procedures; 2. Aged 18 to 75; 3. Locally advanced gastric cancer with TNM staging of cT3-4a/N+ M0, histopathologically diagnosed as adenocarcinoma; According to the definition of Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1), patients must have measurable lesions; 5. Agree to provide formalin-fixed tumor tissue specimens or fresh biopsy tumor lesion tissue from the subjects for biomarker detection; 6. ECOG score of 0-1; 7. Expected survival time >= 6 months; 8. Sufficient organ function, without severe hematopoietic dysfunction, abnormalities in heart, lung, liver, and kidney function, and immune deficiency. Subjects must meet the following laboratory indicators: (1) Hemoglobin (HGB) >= 90g/L; (2) Neutrophil count (NEUT) >= 1.5×10^9/L or white blood cell count (WBC) >= 3×10^9/L; (3) Platelet count (PLT) >= 90×10^9/L; (4) Aspartate aminotransferase (AST) <= 2.5×ULN; (5) Alanine aminotransferase (ALT) <= 2.5×ULN; (6) Total bilirubin (TBIL) <= 1.5×ULN; Blood creatinine (SCr) <= 1.0×ULN;
Exclusion criteria
Exclusion criteria: Subjects who meet the following criteria cannot be enrolled in this study: 1. Patients with other malignant tumors diagnosed within 5 years before the first dose of the combination therapy, excluding gastric cancer; 2. Currently participating in an intervention clinical study for treatment, or having received treatment with other investigational drugs or used investigational devices within 4 weeks prior to the first dose; 3. Previously received radiation therapy, systemic chemotherapy, tumor-targeted therapy, or immunotherapy for gastric cancer; 4. Symptomatic or uncontrolled brain metastases requiring simultaneous treatment, including but not limited to surgery, radiation, and/or corticosteroids, or clinical manifestations of spinal cord compression; 5. Currently, oral or intravenous administration of ß-blockers (such as atenolol, bisoprolol Beta blockers such as carvedilol, labetalol, metoprolol, nadolol, and sotalol 6. Have contraindications to the use of beta blockers (1). Allergic individuals; (2). Patients with bronchial asthma or at risk of bronchospasm; (3). Patients with diabetic ketoacidosis and metabolic acidosis; (4). Patients with bradycardia (heart rate <60 beats per minute), atrioventricular block (second or third degree), sinoatrial block, and sick sinus syndrome; (5). Patients with cardiogenic shock; (6). Patients with right heart dysfunction caused by pulmonary hypertension; (7). Patients with congestive heart failure; (8). Patients with hypotension (systolic blood pressure <90 mmHg, diastolic blood pressure <60 mmHg); (9). Patients in a long-term fasting state; (10). Patients with severe peripheral circulatory failure (such as gangrene); (11). Patients with untreated pheochromocytoma; (12). Patients with variant angina pectoris; 7. Subjects who were receiving systemic glucocorticoid treatment (excluding topical glucocorticoids via nasal spray, inhalation, or other routes) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study medication; Note: Physiological doses of glucocorticoids (<=10 mg/day of prednisone or equivalent) are allowed; 8. Clinically uncontrollable pleural effusion/peritoneal effusion; 9. Known allogeneic organ transplantation (excluding corneal transplantation) or allogeneic hematopoietic stem cell transplantation; 10. Known allergies to the active ingredients or excipients of the study drugs, including oxaliplatin, temozolomide, or propranolol hydrochloride; 11. Prior to the commencement of treatment, the patient has not fully recovered from any toxicity and/or complications caused by any intervention (i.e., = Grade 1 or reaching baseline, excluding fatigue or hair loss); 12. Pregnant or lactating women; 13. Other severe or uncontrollable systemic diseases, such as: (1) Any arterial thrombosis, embolism, or ischemia, such as myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack, within 6 months prior to enrollment in the treatment; (2) History of non-infectious pneumonia requiring glucocorticoid treatment within 1 year before the first dose, or current clinical active interstitial lung disease; (3) Active tuberculosis; (4) There is an active or uncontrolled infection that requires systemic treatment; (5) Patients with clinically active diverticulitis, abdominal abscess, or gastrointestinal obstruction; (6) Liver diseases such as cirrhosis, decompensated liver disease, acute or chronic active hepatitis; (7) Urine routine t
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological complete response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| R0 resection rate;Overall Survival time; | — |
Countries
China
Contacts
Public ContactHanhui Yao
Anhui Provincial Cancer Hospital
Outcome results
None listed