cervical cancer
Conditions
Interventions
single arm:toripalimab combined with chemoradiotherapy
Sponsors
The First Affiliated Hospital of Soochow University
Eligibility
Sex/Gender
Female
Age
20 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Aged 20-70 years; 2. Patients with recurrent/metastatic cervical cancer confirmed by pathology and/or imaging; 3. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1; 4. Expected survival period >= 12 months; 5. Subjuects must have at least one measurable target lesion (According to RECIST v1.1criteria); 6. Subjects shall provide sufficient formalin fixed paraffin embedded (FFPE) specimens or sections prepared from tumor archived tissues or fresh tissues that meet the test criteria, and are willing to perform biopsy of tumor tissues for biomarker analysis if needed; 7. The values of laboratory tests performed during screening shall meet the following criteria: 1) the peripheral blood: white blood cell (WBC)>= 3.0 x 10^9/ L, neutrophils (ANC)>=15 x 10^9/ L, Blood platelet (PLT) >=100 x 10^9 / L, hemoglobin (Hgb) >= 90 g/L; 2) renal function: serum creatinine 40 mL/min (annex Cockcroft Gault formula); 3) liver function: ALT, AST, TBIL <= 1.5*ULN; 8. Women in child-bearing period shall agree to use medically approved effective contraception throughout the whole study period and within 12 months after completion of study; 9. Subjects voluntarily joined the study and signed the informed consent, with good compliance and follow-up; 10. Subject reenrollment: this study allows reenrollment of subjects who have stopped the study due to pre-treatment (i.e., subjects who have not been randomized/not yet received treatment) failure.If reenrolled, the subject must sign the consent form again.
Exclusion criteria
Exclusion criteria: 1. Previously received anti-pd-1, anti-pd-l1 or anti-pd-l2 treatment; 2. Known allergic to recombinant humanized anti-pd-1 monoclonal antibody and its components; 3. Active central nervous system (CNS) metastasis, including symptomatic brain metastasis or meningeal metastasis or spinal cord compression, etc; or active bone metastasis; 4. Unmeasurable lesions or lesions that cannot be evaluated; 5. Have severe acute infection and have not been controlled; Or have suppurative sex and chronic infection, wound delay does not heal; 6. Unstable angina pectoris, myocardial infarction, coronary artery bypass grafting, congestive heart failure, cerebrovascular accident (including transient ischemic attack and pulmonary embolism) occurred in the first 3 months after enrollment. 7. Persistent arrhythmia (CTCAE level 2 and above), atrial fibrillation of any degree, prolonged Qtc interphase (prolonged by more than 470 ms in women). 8. Refractory hypertension (blood pressure is still higher than 150/100 mm Hg after optimal drug treatment). 9. Patients with uncontrollable neurological, mental illness or mental disorder, poor compliance and inability to cooperate and describe treatment responses; 10. Patient with other previous malignancies shall not participate in this study unless she experiences a "complete response" for at least 5 years before enrollment, and it is estimated that no other anti-tumor therapy will be required during the whole study; 11. Patients who also participate in other clinical trials; 12. HIV positive;HCV positive;HBsAg or HBcAb positive patients also detected positive HBV DNA copy number (quantitative detection limit was 500IU/ml). 13. There are active autoimmune diseases (such as the use of disease-regulating drugs, corticosteroids or immunosuppressive drugs) that have required systematic treatment in the past two years, allowing for related alternative therapies (such as thyroxine, insulin, or physiological corticosteroid replacement therapy for renal or pituitary dysfunction); 14. Received live vaccination within 4 weeks prior to the start of treatment;According to the investigator, other severe, acute or chronic medical conditions or laboratory abnormalities that may increase the risk associated with participating in the study or that may interfere with the interpretation of the study results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival;Time-to Progression;overall survival;Safety; | — |
Countries
China
Contacts
Public ContactZhou Juying
The First Affiliated Hospital of Soochow University
Outcome results
None listed