Cervical cancer
Conditions
Interventions
Case series:Carelizumab combined with concurrent chemoradiotherapy
Sponsors
He'nan Cancer Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-70 years old on the day of signing the informed consent; Histopathologically diagnosed advanced cervical cancer patients were initially diagnosed as stage IVB according to the 2018 FIGO stage; 2. Patients with primary focus and metastasis who have not received anti-tumor treatment; 3. ECOG score 0-1 points; 4. Expected survival time >=3 months; 5. Patients must have measurable lesions as specified in RECIST version 1.1; Measurable disease is defined as at least one lesion that can be accurately measured on at least one level (the long path needs to be recorded); For imaging (MRI) measurements, each lesion must be> 10 mm, and the lymph nodes must be> 15 mm on the short axis. According to RECIST version 1.1, patients must have at least one "target" lesion to evaluate the response to this protocol; tumors in the previously irradiated field will be designated as "non-target lesions"; 6. PD-L1 or MSI / dMMR can be detected in pathological specimens or tissues; 7. Laboratory inspection indicators within 14 days meet the following conditions: peripheral blood: white blood cells (WBC) >=3.0x10^9/L, neutrophils (ANC) >=1.5x10^9/L, platelets (PLT) >=100x10^9/L, hemoglobin (HGb) >=90g/L; renal function: serum creatinine 40 mL / min; liver function: alanine aminotransferase (ALT) And aspartate aminotransferase (AST) <=2.5 ULN; if liver metastases, ALT or AST <= 5 ULN; total bilirubin <=1.5 ULN; 8. Subjects voluntarily join the study, signed informed consent, good compliance and cooperated with follow-up.
Exclusion criteria
Exclusion criteria: 1. Those who cannot tolerate or refuse to perform concurrent chemoradiotherapy and immunotherapy; 2. People who are allergic to recombinant humanized anti-PD-1 monoclonal antibody drugs and their components; 3. People with meningeal metastases or symptomatic central nervous system metastases; 4. Patients with no measurable or non assessable lesions; 5. Those who have severe acute infections and are not controlled; or those who have purulent and chronic infections and the wounds are not healed; 6. Suffering from other complications such as myocardial infarction, severe arrhythmia, severe cerebrovascular disease, psychosis and uncontrollable diabetes, persistent arrhythmia (CTCAE standard level 2 and above), any degree of atrial fibrillation, Prolonged (prolonged more than 470 milliseconds in women), refractory hypertension (blood pressure is still higher than 150/100 mm Hg after optimal drug treatment); 7. Those who have difficult to control neurological, psychiatric diseases or mental disorders, have poor compliance and cannot cooperate with and describe treatment response; 8. Have human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS), active hepatitis B (HBV DNA = 500 IU / ml), hepatitis C (hepatitis C antibody positive, and HCV -RNA is above the detection limit of the analytical method); 9. Patients with active autoimmune diseases requiring systematic treatment in the past 2 years(such as the use of disease-modifying drugs, corticosteroids, or immunosuppressive drugs) ; 10. Patients who received live vaccinations or planned vaccinations during the study within 4 weeks before the start of treatment; 11. In the opinion of the investigator, those conditions that may increase the risk associated with participating in the study or other severe, acute or chronic medical diseases or laboratory abnormalities that may interfere with the interpretation of the study results. 12. Patients who had major surgery (except baseline tumor biopsy) or severe trauma within 4 weeks before the start of the study; 13. People with other malignant tumors; 14. Pregnant or lactating women; 15. Patients participating in other clinical trials at the same time; 16. Other situations that some researchers think are not suitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate, ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival, PFS;Disease control rate, DCR;Overall survival, OS; | — |
Countries
China
Contacts
Public ContactShuxia Cheng
He'nan Cancer Hospital
Outcome results
None listed