Colorectal cancer
Conditions
Interventions
Test Group:Cadonilimab combined with anti-angiogenesis targeted agents
Sponsors
North China University of Science and Technology Affiliated Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Sign written informed consent prior to enrollment. 2.Age > 18, male or female. 3.Patients with histologically or pathologically confirmed advanced metastatic solid tumors. 4.Progression after standard first - or second-line systemic therapy. 5.Have measurable lesions (CT long diameter of non-lymph node lesions =10 mm ,CT short diameter of lymph node lesions =15 mm , according to RECIST 1.1 standards). 6.ECOG PS score: 0 ~ 2. 7.The expected survival times is greater than 12 weeks. 8.The functions of vital organs meet the following requirements (excluding the use of any blood components and cell growth factors within 14 days) : 1) Blood routine: Neutrophilicgranulocyte=1.5×109/L Platelet count =100×109/L Hemoglobin = 90g/L; 2) Liver and kidney function: Serum creatinine (SCr) = 1.5 times the upper limit of normal; Creatinine clearance =50 ml/min (Cockcroft-Gault formula); Subjects without liver metastasis aspartate aminotransferase (AST) =2.5 x ULN or Alanine liver aminotransferase (ALT) =2.5 x ULN; ALT and AST<5 x ULN in subjects with liver metastasis; Serum total bilirubin (TBIL) =1.5 x ULN (except Gilbert syndrome total bilirubin < 3.0 mg/dL); Urinary protein <2+; If urinary protein =2+, the 24-hour urinary protein quantitation must indicate protein =1g;1) 9. Normal coagulation function, no active bleeding and thrombosis disease. 1) International normalized ratio(INR) =1.5×ULN; 2) activated partial thromboplastin time (APTT) =1.5×ULN; 3) Prothrombin time(PT) =1.5×ULN; 10.Non-surgical sterilization or women of reproductive age who are required to use a medically approved contraceptive (such as an intrauterine device, contraceptive pill or condom) during the study treatment period and within 3 months after the study treatment period ends; Female patients of childbearing age who were not surgically sterilized must have a negative serum or urine HCG test within 7 days prior to study enrollment; And must be non-lactation period; Male patients of non-surgical sterilization or reproductive age are required to consent to use a medically approved contraceptive method with their spouse during the study treatment period and for 3 months after the study treatment period ends. 11.The subjects voluntarily participated in the study with good compliance for safety and survival follow-up.
Exclusion criteria
Exclusion criteria: 1.Subjects has had or co-had other malignancies (except cured basal cell carcinoma of the skin and cervical carcinoma in situ). 2.The subjects is known to have a prior allergy to macromolecular protein preparations, or to a known drug component applied. 3.Subjects had any active autoimmune disease or a history of autoimmune disease (e.g., but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, pituitaritis, vasculitis, nephritis, hyperthyroidism, hypothyroidism, and previous thyroid surgery were not included; Subjects who had vitiligo or had complete remission of asthma in childhood could be included without any intervention as adults; Patients with asthma requiring medical intervention with bronchodilators are not included). 4.Subjects who were on immunosuppressive, systemic, or absorbable topical hormone therapy for immunosuppressive purposes (dose >10mg/ day prednisone or other therapeutic hormone) and continued to use within 2 weeks prior to enrollment. 5.Subjects have clinical symptoms of ascites or pleural effusion requiring therapeutic puncture or drainage. 6.Subjects have the following poorly controlled cardiac clinical symptoms or diseases: 1) Heart failure (NYHA Rank>2); 2) Unstable angina pectoris; 3) Myocardial infarction occurred within 1 year; 4) Patients with clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention. 7.Subjects with active infection or unexplained fever >38.5 degrees during screening and prior to initial administration (as determined by the investigator, subjects with fever due to tumor can be enrolled). 8.Previous and current objective evidence of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-related pneumonia, severe impairment of lung function, etc. 9.Subjects with congenital or acquired immune dysfunction, such as HIV infection, or active hepatitis (transaminase did not meet the inclusion criteria, hepatitis B reference: HBV DNA=1000 IU/ml; Hepatitis C reference: HCV RNA=1000 IU/ml); Chronic hepatitis B virus carriers with HBV DNA < 2000 IU/ml must also receive antiviral therapy during the trial to be enrolled. 10. Live vaccines were administered less than 4 weeks before or possibly during the study period. 11. The subject has a known history of psychotropic substance abuse, alcoholism, or drug use. 12. Received Chinese herbal medicine or Chinese patent medicine with anti-tumor indications within 2 weeks prior to initial administration. 13.The investigator considers that the subjects should be excluded from the study if, in the judgment of the investigator, they have other factors that may lead to the termination of the study, such as other serious medical conditions (including mental illness) requiring concomitant treatment, serious abnormalities in laboratory tests, and family or social factors that may affect the safety of the subjects or the collection of data and samples.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-Free-Survival Time;Duration of Response; | — |
Countries
China
Contacts
Public ContactJia Jinghao
North China University of Science and Technology Affiliated Hospital
Outcome results
None listed