Patients with unresectable or metastatic advanced solid tumors
Conditions
Interventions
Single arm:cardonilumab (AK104) in combination with SBRT
Sponsors
Fujian Provincial Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Patients with advanced malignant solid tumors who need local therapy (through SBRT) after failure of standard therapy or without standard therapy 2. Age range: 18-75 years old, male or female; 3. Patients with unresectable or metastatic solid tumors confirmed by pathology (including histology or cytology). 4. According to the RECIST V1.1 criteria, the investigators judged that there were at least two or more measurable lesions, and the size and diameter of the lesions must be greater than 1.0cm. 5. No serious dysfunction of heart, brain, liver, lung, kidney and other important organs, no serious concomitant diseases, and the physical condition can tolerate radiotherapy, chemotherapy and surgery. 6.ECOG PS: 0-2 points; 7. Expected survival =6 months; 8. The functions of the main organs are normal, and the blood routine, blood biochemistry and coagulation function examination are basically normal; 9. The immune indexes are basically normal; 10. Women of childbearing age must have been using reliable contraception or have had a pregnancy test (serum or urine) with negative results within 7 days prior to inclusion and be willing to use an appropriate method of contraception during the trial period and 8 weeks after the last test drug administration. For males, consent is required to use an appropriate method of contraception or surgical sterilization during the trial period and 8 weeks after the last administration of the trial drug; 11. The subjects voluntarily joined the study and signed the informed consent. The subjects had good compliance and cooperated with follow-up visits.
Exclusion criteria
Exclusion criteria: 1. The tumor may invade the bronchi or large blood vessels, and has a tendency to bleed 2.5% of patients. Patients with suboptimal blood pressure control (systolic blood pressure =160 mm HG or diastolic blood pressure =100 mm Hg) ; 3. Known or suspected active autoimmune diseases, history of autoimmune diseases (e.g. interstitial pneumonia, colitis, hepatitis, pituitary, vasculitis, nephritis, hyperthyroidism, hypothyroidism, including but not limited to these diseases or syndromes) ; Four. History of immunodeficiency, including HIV-positive, or other acquired, congenital immunodeficiency disease, or history of organ transplantation or allogeneic bone marrow transplantation 5. Interstitial lung disease, drug-induced pneumonia, radiation pneumonitis requiring steroid therapy or clinically symptomatic active pneumonia or severe pulmonary dysfunction; 6. Subjects with poorly controlled cardiovascular clinical symptoms or disease, including, but not limited to: (1) NYHA Class II or higher heart failure (2) unstable angina (3) myocardial infarction within 1 year (4) clinically significant supraventricular or ventricular arrhythmias that did not undergo clinical intervention or were poorly controlled after clinical intervention 7. Subjects had active hepatitis B (HBV DNA =2000 IU/mL or 104 copies/mL) and hepatitis C (HCV antibody positive and HCV-RNA above the lower limit of detection for the analytical method) ; 8. Hereditary bleeding or Coagulopathy. Significant bleeding or a definite bleeding tendency, such as gastrointestinal bleeding, bleeding gastric ulcer, or stool occult blood + + at baseline, occurred within 3 months before enrollment. 9. Previous antineoplastic therapy toxicities did not return to = CTCAE grade 1(except alopecia) or the levels specified by the inclusion/exclusion criteria; 10. People with known or suspected allergies to experimental drugs; 11. Pregnant or lactating women; not considered suitable for inclusion by the researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate (ORR) ;disease control rate (DCR) ;safety; | — |
Secondary
| Measure | Time frame |
|---|---|
| progression-free survival, PFS;overall survival, OS; | — |
Countries
China
Contacts
Public ContactJuhui Chen
Fujian Provincial Cancer Hospital
Outcome results
None listed