Cervical cancer
Conditions
Interventions
Experimental group:AK105 combined with anlotinib
Sponsors
The First Affiliated Hospital of Zhengzhou University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Patients voluntarily participated in the study and signed informed consent; 2.Women aged 18 to 75 years; 3.Agreed to detect the expression status of PD-L1 biomarker; 4.ECOG score is 0 or 1, and the expected survival time is not less than 3 months; 5.Histologically confirmed recurrent or metastatic squamous cell carcinoma, adenocarcinoma, and adenosquamous carcinoma with documented disease progression. Note that histological confirmation of the original primary tumor is required by pathological reports; 6.Patients with recurrent or metastatic cervical cancer who had received at least once platinum-based systemic chemotherapy were included; 7.The patient is not suitable for local treatment (surgery or radiotherapy cannot be performed); 8.Patients with measurable lesions as defined in RECIST1.1 criteria; 9.The main organs function is well, and the laboratory test indexes meet the following requirements: (1)Routine blood test (no blood transfusion or hematopoietic stimulating factor was used within 7 days before screening): 1)Hemoglobin (HB) >= 90g/L; 2)Absolute neutrophil count (ANC) >= 1.5x10^9/L; 3)Platelet (PLT) >= 80 x 10^9/L; (2)Blood biochemical test (no blood transfusion or albumin within 7 days before screening) : 1)ALT and AST = 60 mL /min; (3)Coagulation function test: 1)Activated partial thrombin time (APTT), international standardized ratio (INR), prothrombin time (PT) = 50%; 10.Any toxic side effects of previous chemotherapy have been recovered to <= CTCAE1 or baseline level; 11.The patient has the ability to take medication orally; 12.Women of reproductive age must agree to use a highly effective method of contraception during the study period and for 6 months after the last administration of the study drug; Negative serum or urine pregnancy test within 7 days prior to study enrollment and must be non-lactating subjects;
Exclusion criteria
Exclusion criteria: 1.Patients with a history or signs of brain metastases; 2.Prior use of bevacizumab, anlotinib and other antiangiogenic drugs; 3.Received anti-tumor monoclonal antibody treatment within 4 weeks before enrollment; Had previously received other PD-1/PD-L1 antibodies and anti-CTLA-4 (cytotoxic T-lymphocyte associated antigen-4) therapy; 4.Patients were receiving immunosuppressant or systemic hormone therapy for immunosuppression (dose > 10mg/ day of prednisone or other equivalent hormone) and were still using 2 weeks prior to enrollment; 5.Participate in other clinical trials or complete other clinical trials within 4 weeks; 6.Abnormal coagulation function (INR > 2.0, PT > 16s), bleeding tendency or receiving thrombolytic or anticoagulant therapy; 7.Failed to recover from adverse events (except hair loss) after prior medication use; 8.The patient has any active autoimmune disease or a history of autoimmune disease; 9.Clinical symptoms or diseases of the heart that are not well controlled; 10.Congenital or acquired immune deficiency; 11.Received chemotherapy, targeted and radiotherapy within 2 weeks before enrollment; 12.Concomitant diseases/history: (1)Clinically significant hemoptysis occurred within 3 months before enrollment (hemoptysis > 50ml per day); Or bleeding symptoms of significant clinical significance or a clear bleeding tendency, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, baseline fecal occultation and above, or suffering from vasculitis, etc.; (2)Arteriovenous thrombosis events occurred within 6 months before enrollment, such as cerebrovascular accident (including temporary ischemic attack), deep venous thrombosis (except those who had been cured after intravenous catheterization due to previous chemotherapy) and pulmonary embolism, etc.; (3)Hypertension that cannot be well controlled by antihypertensive medication (systolic blood pressure > 140 mmHg or diastolic blood pressure >90 mmHg); During the first 6 months of randomization, myocardial infarction, severe/unstable angina, NYHA grade 2 or higher cardiac dysfunction, clinically significant ventricular arrhythmias or ventricular arrhythmias, and symptomatic congestive heart failure; (4)Interstitial lung disease, non-infectious pneumonia or uncontrollable systemic diseases (e.g., diabetes, pulmonary fibrosis and acute pneumonia); (5)Renal insufficiency: urine protein >= ++ indicated by routine urine examination, or confirmed 24-hour urine protein level >=1.0g; (6)History of live attenuated vaccine vaccination within 28 days prior to initial study administration or expected live attenuated vaccine vaccination during study period; (7)Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS); Active hepatitis (hepatitis B, defined as HBV-DNA >= 500 IU/ mL; Hepatitis C, defined as HCV-RNA higher than the lower limit of assay) or co-infection with hepatitis B and C; (8)Severe infection, including but not limited to bacteremia and severe pneumonia requiring hospitalization, occurred within 4 weeks before the first administration; Active infection with CTCAE grade >= 2 requiring systemic antibiotic treatment within 2 weeks prior to initial administration, or fever of unknown origin > 38.5 degree C during screening/prior to initial administration (as determined by the investigator, fever due to tumor can be included); Evidence of active tuberculosis infection within 1 year before administration; (9)Have
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate;Progression-Free Survival;Time from enrollment to first follow-up treatment;Overall survival;Life quality score; | — |
Countries
China
Contacts
Public ContactGuo Ruixia
Outcome results
None listed