Cancer
Conditions
Interventions
Experimental group 1:Ivonescimab (Ivonescimab monoclonal antibody) at a dose of 10mg/Kg, 20mg/kg or 30mg/kg, administered by intravenous infusion on D1, Q3W.
Experimental group 2:Ivonescimab plus FSRT radiotherapy regimen
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) Age: >= 18 years old and = 9.0 g/dL (90 g/L); Absolute neutrophil count (ANC) >= 1,500/mcL (1.5×10^9/L); Total platelet count (PLT) >= 100,000/mcL (100×10^9/L); 8) Good liver function, defined as all the following conditions: Total bilirubin (TBIL) = 30g/L; 9) Coagulation function: International normalized ratio (INR) or prothrombin time (PT), activated partial thromboplastin time (APTT) 1.5×ULN, creatinine clearance rate (Ccr) >= 50 mL/min (the creatinine clearance rate should be calculated using the corrected Cockcroft - Gault formula. If there is no local guideline available, the creatinine clearance rate can be calculated: Ccr =[(140 - age)×weight(kg)×(0.85 only for females)]/(72×serum creatinine)] (without significant electrolyte imbalance that is difficult to correct); 11) Baseline left ventricular ejection fraction (LVEF) measured by multiple - gated acquisition (MUGA) or echocardiogram (ECHO) >= 50%; 12) No severe organic heart disease and arrhythmia; 13) Women of childbearing age (15 - 49 years old) must undergo a pregnancy study within 7 days before the start of treatment and the result is negative; Male and female patients with child - bearing potential must agree to use effective contraceptive measures to ensure that they do not get pregnant during the study period and within 3 months after the end of treatment; 14) Obtain the informed consent form voluntarily signed by the patient himself/herself.
Exclusion criteria
Exclusion criteria: 1) Peripheral neuropathy of grade >= 2 (according to CTCAE 5.0). 2) Anticipated need for surgery or any other form of systemic or local anti-tumor treatment during the study period. 3) Received systemic chemotherapy or immunotherapy within 3 weeks prior to the first administration of the study drug. 4) Residual toxic reactions (except alopecia, fatigue, and grade 2 hypothyroidism) or clinically significant abnormal laboratory test values above grade 1 (CTCAE v5.0) caused by previous anti-tumor treatments (including immunotherapy, targeted therapy, chemotherapy, or radiotherapy, etc.). 5) Uncontrolled or poorly controlled heart diseases, including congestive heart failure (CHF) of grade >= 2 (CTCAE v5.0 or New York Heart Association classification), myocardial infarction, unstable angina pectoris, history of ventricular tachycardia or torsades de pointes, or arrhythmias requiring treatment, such as QTcF > 450 ms in men and QTcF > 470 ms in women, presence of complete left bundle branch block or third-degree atrioventricular block within 6 months before enrollment. QTcF = QT/(RR^0.33). 6) Pulmonary embolism or deep vein thrombosis occurred within 3 months prior to the first administration of the study drug (except for thrombosis derived from infusion ports or PICC catheters). 7) Any severe or uncontrolled systemic diseases, including uncontrolled or poorly controlled hypertension (such as systolic blood pressure > 160 mmHg or diastolic blood pressure > 100 mmHg), diabetes (glycated hemoglobin (HbA1c) > 8%), etc. 8) Patients with active bleeding, history of coagulation disorders, or receiving coumarin anticoagulant therapy. 9) Known active hepatitis B or hepatitis C. Active hepatitis B is defined as known HBsAg positive and HBV DNA >= 500 IU/mL. Active hepatitis C is defined as known positive hepatitis C antibody and known quantitative hepatitis C virus HCV RNA result above the lower limit of detection. Presence of other severe liver diseases, including chronic autoimmune liver disease, primary biliary cirrhosis or sclerosing cholangitis, alcoholic liver disease, or non-alcoholic steatohepatitis (NASH). 10) Concurrent severe, uncontrolled infection, known human immunodeficiency virus (HIV) (HIV antibody positive) infection, or diagnosis of acquired immunodeficiency syndrome (AIDS); or uncontrolled autoimmune diseases; or previous receipt of allogeneic tissue/organ transplantation, stem cell or bone marrow transplantation, or previous receipt of solid organ transplantation. 11) Active bacterial, viral, fungal, rickettsial, or parasitic infections requiring systemic anti-infective treatment (unless treated and resolved prior to the administration of the study drug). 12) Vaccinated with live virus vaccines within 30 days prior to the first administration of the study drug. Inactivated virus seasonal influenza vaccines or approved COVID-19 vaccines are allowed, and the time from the first dose of the study drug should be more than 1 week. 13) History of interstitial pneumonia, severe chronic obstructive pulmonary disease complicated with respiratory failure, severe pulmonary insufficiency, symptomatic bronchospasm, etc. 14) Received immunology-based treatments for any reason, including long-term use of systemic steroids equivalent to > 10 mg/day prednisone within 7 days prior to the first administration of the study drug or at any time during the study. Note: Inhaled or topical steroids or systemic corticosteroids equivalent to <= 10 mg/da
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety;Progression-Free-Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate;Duration of Response;Disease Control Rate;Overall Survival; | — |
Countries
China
Contacts
Public ContactWang Feng
West China Hospital of Sichuan University
Outcome results
None listed