The Efficacy and Safety of Benmelstobart for GC/EGC (NCT06603974) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
The Efficacy and Safety of Benmelstobart for GC/EGC
48 participantsStarted 2024-10-16
Plain-language summary
The goal of this clinical trial is to evaluate the major pathological response (MPR) rate of locally advanced gastric cancer / gastroesophageal junction cancer treated with bemosumab combined with antiangiogenic drugs and neoadjuvant chemotherapy.
Researchers will use drug Benmelstobart in combination with antiangiogenesis drugs and newadjuvant chemotherapy to see if the drug works to treat locally advanced gastric cancer / gastroesophageal junction cancer.
Participants will:injection drug Benmelstobart，On the first day of each cycle, 3 weeks (21 days) were a treatment cycle.
Who can participate
Age range18 Years – 70 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Blood routine examination must meet the following requirements (no blood transfusion, no use of hematopoietic factors and no use of drugs for correction within 14 days):
✓. ANC ≥ 1.5 × 109/l;
✓. PLT ≥ 100 × 109/l;
✓. HB ≥ 90 g/L；
✓. Biochemical tests must meet the following criteria:
✓. TBIL ≤ 1.5 × ULN;
✓. Alt, AST ≤ 2.5 × ULN
✓. Serum creatinine SCR ≤ 1.5 × ULN, endogenous creatinine clearance ≥ 50 ml / min (Cockcroft Gault formula);
Exclusion criteria
✕. Patients with distant metastasis;
✕. Subjects who had previously received anti-PD-1 (L1) or CTLA4 mAb therapy;
✕. Other malignant tumors in the past 3 years;
✕. Have any history of active autoimmune disease or autoimmune disease (as follows, but not limited to: interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism (can be included after hormone replacement therapy)); Patients with vitiligo or childhood asthma have been completely relieved and can be included without any intervention in adults; Patients who needed bronchodilators for medical intervention could not be included;
✕. Immunosuppressive drugs used within 14 days before the first use of study drugs, excluding nasal spray and inhaled corticosteroids or physiological doses of systemic steroids (i.e. no more than 10 mg/ day prednisone or its equivalent);
✕. Uncontrolled hypertension (systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg despite optimal medical treatment);
✕. Patients with newly diagnosed angina within 3 months before screening or myocardial infarction within 6 months before screening; Arrhythmias (including QTCF: ≥ 450 ms for men and ≥ 470 MS for women) require long-term use of antiarrhythmic drugs and New York Heart Association class ≥ II cardiac insufficiency; Or uncontrollable heart failure;
✕. There is evidence that there are previous or current pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiologic pneumonia, drug-induced pneumonia and severe impairment of lung function;