Cervical cancer
Conditions
Interventions
Experimental group:Carrilizumab combined with large fractionated radiotherapy
Sponsors
Guilin People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. The patients voluntarily joined the clinical study and signed the informed consent form, with good compliance and able to cooperate with follow-up; 2. The age of 18-75 years old when signing the informed consent; 3. Cervical cancer confirmed by histopathology, including cervical squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma; 4. Unable to be cured by surgery, radiotherapy/chemotherapy; 5. According to the RECIST 1.1 standard, the patient must have at least one measurable lesion (the lesion that has received radiotherapy must show definite progression before it can be regarded as a measurable lesion); 6. ECOG PS score: 0-1 points; 7. Expected survival period >= 3 months; 8. Vital organ function must meet the following criteria: (1) Routine blood examination: (no blood transfusion, no use of G-CSF and other cytokine drugs to correct treatment within 2 weeks before enrollment); 1) Hemoglobin (HB) >= 90 g/L; 2) Absolute neutrophil count (ANC) >= 1.5x10^9/L; 3) Platelet count (PLT) >= 80 x 10^9/L; 4) White blood cell count (WBC) >= 3.0x10^9/L and = 30g/L; 5) Cr = 60mL/min (Cockcroft-Gault formula); 6) TSH = 50%; 9. Subjects with potential fertility need to use at least one medically approved contraceptive measure (such as an intrauterine device, contraceptives or condoms) during the study treatment and within 180 days after the end of the study treatment; and The serum HCG test within 72 hours before the group must be negative; and must be non-lactation period.
Exclusion criteria
Exclusion criteria: 1. There is no activity, known or suspected autoimmune disease (including but not limited to: myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, multiple sclerosis, vasculitis, glomerulonephritis, uveitis, the pituitary gland inflammation, thyroid function hyperfunction, etc.). Patients with type I diabetes that received a steady dose of insulin, hypothyroidism that only received hormone replacement therapy, and skin conditions that did not require systemic therapy and had no acute deterioration within 1 year prior to the screening period (e.g., eczema, vitiligo, or psoriasis) were admitted; 2. Subjects who received systemic treatment with corticosteroids (>10 mg/ day of prednisone or other hormone equivalents) or other immunosuppressants within 1 month prior to enrollment. In the absence of active autoimmune disease, inhaled or topical corticosteroids are permitted, as well as adrenal hormone replacement therapy at doses = 4 weeks); 4. Patients with ascites or pleural effusion with clinical symptoms, those who need puncture drainage or have received thoracic or ascites drainage within 2 weeks prior to signing informed consent, except those who only show a small amount of ascites or pleural effusion without clinical symptoms; 5. Patients with bilateral hydronephrosis and unilateral hydronephrosis should be enrolled after ureteral stenting; 6. Previous or co-existing malignancies, except for basal cell carcinoma of the skin, superficial bladder, squamous cell carcinoma of the skin, or carcinoma in situ, which had achieved a complete response at least 5 years prior to screening and did not require or are expected to require other treatment during the study period; 7. There is no activity, known or suspected autoimmune disease (including but not limited to: myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, multiple sclerosis, vasculitis, glomerulonephritis, uveitis, the pituitary gland inflammation, thyroid function hyperfunction, etc.). They were admitted for type 1 diabetes that received a steady dose of insulin, hypothyroidism that only received hormone replacement therapy, and skin conditions that did not require systemic therapy and did not have an acute exacerbation (e.g., eczema, vitiligo, or psoriasis) within 1 year prior to the screening period; 8. Patients with past or present objective evidence of idiopathic pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-induced pneumonia, or active pneumonia shown by CT during screening period or severely impaired lung function confirmed by pulmonary function examination; 9. Cardiac clinical symptoms or diseases that are not well controlled, such as : (1) Nyha grade 2 or more heart failure; (2) Unstable angina; (3) Myocardial infarction within 1 year; (4) Clinically significant ventricular or ventricular arrhythmias requiring treatment or intervention; 10. Patients with hypertension that cannot be well controlled by antihypertensive medication (systolic blood pressure >=140 mmHg or diastolic blood pressure >= 90 mmHg); 11. For those with thrombosis tendency or receiving thrombolytic/anticoagulant therapy, the prophy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival (PFS); | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Objective response rate;Duration of remission;To the time of remission;Disease control rate;To the time of treatment failure; | — |
Countries
China
Contacts
Public ContactHuang Hui
Guilin People's Hospital
Outcome results
None listed