Recurrent or metastatic cervical cancer
Conditions
Interventions
Single arm:Brachytherapy with iodine-125 seeds
Single arm:PD-1 inhibitors
Sponsors
Hebei General Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Voluntary participation in clinical research; Fully understand and be informed of the study and sign the informed consent; Willing to follow and be able to complete all test procedures; 2. Age: >=18 years old; 3. The primary lesion was confirmed to be cervical cancer by tissue/cytological biopsy; 4. Recurrent or metastatic cervical cancer was confirmed by pathology or imaging, which was not suitable for radical treatment such as surgery and radiotherapy; 5. Patients with recurrent or metastatic cervical cancer who have progressed after first-line or above standard chemotherapy containing platinum confirmed by imaging or cannot tolerate platinum drug therapy; 6. At least one measurable lesion (RECIST 1.1) should be evaluated by CT scan or MRI within 28 days prior to treatment; 7. ECOG score was 0 to 1; 8. Expected survival >=3 months; 9. No prior immunotherapy; 10. The functions of major organs met the following criteria within 7 days before treatment: (1) Blood routine examination criteria (no blood transfusion within 14 days): 1) HB >= 100g/L; 2) The absolute value of neutrophil (ANC) >=1.5*10^9/L; 3) Platelet (PLT) >= 80*10^9/L; (2) Biochemical tests should meet the following criteria: 1) Total bilirubin (TBIL) = 60ml/min; (3) International standardized ratio (INR) or plasma prothrombin time (PT) = the lower limit of normal value (50%); 11. Female participants of reproductive age had a negative serum pregnancy test (if fertile) within 72 hours prior to study treatment and agreed to use contraception (such as an intrauterine device, birth control pill, or condom) or not fertile potential during and for 6 months after study completion. Male partners must agree to use an appropriate contraceptive method from the beginning of the first dose of study treatment until six months after the last dose of study treatment.
Exclusion criteria
Exclusion criteria: 1. Have been treated with anti-PD-1 antibody, anti-PD-L1 antibody, anti-PD-L2 antibody, anti-CD137 antibody, or anti-lymphocyte antigen 4 (CTLA-4) antibody (including Ipilimumab or any other antibody or drug specifically targeting the T cell synergistic stimulation or checkpoint pathway); 2. Had received other anti-tumor therapy (including chemotherapy, molecular targeted therapy, radiotherapy, immunotherapy, monoclonal antibody therapy) or participated in clinical studies of other unmarketed drugs within 4 weeks prior to the start of study therapy; 3. Known prior allergy to macromolecular protein preparations/monoclonal antibodies, or known allergy to any of the test drug components; 4. Pregnant or lactating women; 5. There are active autoimmune diseases and treatment system in the past 2 years (such as corticosteroids or immunosuppressive drugs (such as the following, but not limited to: uveitis, enteritis, hepatitis, the pituitary gland inflammation, vasculitis, nephritis, thyroid function of hyperthyroidism, hypothyroidism [asymptomatic hypothyroidism or hypothyroidism caused by radiation and chemotherapy can be incorporated into]; Subjects with vitiligo or asthma in complete remission in childhood without any intervention as adults may be included); 6. Patients who needed systemic corticosteroids (at a dose equivalent to or higher than 10 mg/ day of prednisone) or other immunosuppressive drugs within 14 days prior to enrollment or during the study period; 7. Patients with meningeal metastasis or symptomatic central nervous system metastasis; 8. Those who received live vaccine within 4 weeks prior to the start of treatment; 9. Those who have received anti-tumor vaccine or anti-tumor therapy with systemic immune stimulation; 10. Accompanied by serious medical diseases, Such as severe infection, uncontrolled diabetes, cardiovascular disease (class III or IV heart failure as defined by the New York Heart Association scale, heart block at or above grade II, myocardial infarction, unstable arrhythmia or unstable angina within the past 6 months, 3 Cerebral infarction, etc.) or pulmonary diseases (interstitial pneumonia, obstructive pulmonary disease, and history of symptomatic bronchospasm), cerebrovascular accidents (including transient ischemic attack or symptomatic pulmonary embolism); 11. Hepatitis B surface antigen (HBsAg) and/or hepatitis B core antibody (HBcAb) positive and HEPATITIS B virus deoxyribonucleic acid (HBV DNA) & GT; 103 copy number /ml, or hepatitis C virus antibody positive; Syphilis positive; 12. A history of human immunodeficiency virus infection or other acquired, congenital immunodeficiency disease; 13. History of autoimmune diseases, idiopathic pulmonary fibrosis, tissue pneumonia, drug pneumonia, idiopathic pneumonia or chest CT scan of active pneumonia, history of interstitial lung disease, active tuberculosis, etc.; 14. Patients who suffered from other malignant tumors within 5 years prior to enrollment were excluded from any type of carcinoma in situ that had been cured previously and cured basal cell carcinoma of skin or squamous cell carcinoma of skin; 15. Had previously received allogeneic hematopoietic stem cell transplantation or solid organ transplantation; 16. Major surgical surgery (except for baseline tumor biopsy) or severe trauma within 4 weeks prior to the start of study treatment; 17. Have a history of alcoholism, drug abuse or drug abuse in the past 1 year; 18. Have a clear hist
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate, ORR;Progression Free Survival, PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease Control Rate, DCR;Duration of Response, DOR;Overall Survival, OS; | — |
Countries
China
Contacts
Public ContactHuimin Yu
Hebei General Hospital
Outcome results
None listed