cervical cancer
Conditions
Interventions
Experimental group:Carillizumab + apatinib
Targeted group:apatinib
Immunity group:carrillizumab
Sponsors
Shandong Tumor Combat Research Institute
Eligibility
Sex/Gender
Female
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Aged >= 18 years, counted as the date of signing informed consent; 2. Patients with pathologic diagnosis of cervical cancer and pathological stage IV. It does not contain the following rare pathologic types: microadenocarcinoma, villous tubular adenocarcinoma, clear cell carcinoma, or sarcoma. 3. Patients without any treatment for the primary lesion; 4. All cases must have measurable disease as defined in RECIST 1.1; Measurable disease is defined as at least one lesion that can be accurately measured at at least one level (long diameter recorded); When measured by computed tomography (CT), magnetic resonance imaging (MRI), or gynecologic examination, each lesion must be > 10mm. Or >= 20mm by chest X-ray measurement; Lymph nodes must be > 15mm along the short axis when measured by CT or MRI. According to RECIST 1.1, patients must have at least one "target" lesion to evaluate the response to the protocol; Tumors previously exposed in the field will be designated as "non-target lesions". 5. ECOG score: 0-2; 6. Expected survival >= 3 months; 7. Main organs are functioning normally, which means they meet the following criteria: (1) blood routine examination criteria should be met (no blood transfusion or blood products within 14 days): a. ANC>=1.5 x 10^9/L; b. PLT >= 80 x10^9/L; C. Hemoglobin >= 9g/dL; (2) biochemical examination shall meet the following criteria: a. total bilirubin =50 ml/min (Cockcroft-Gault formula); 8. Subjects voluntarily participate in this study and sign informed consent, with good compliance and follow up.
Exclusion criteria
Exclusion criteria: 1. Those who have been using chemotherapy drugs/targeted drugs/immunotherapy; 2. Known allergy to apatinib mesylate, carillizumab, or any ingredient; 3. Contraindications of chemoradiotherapy, including severe infection or other complications such as myocardial infarction, severe arrhythmia, severe cerebrovascular disease, psychosis and uncontrollable diabetes; 4. Pregnant or lactating women; 5. Multiple factors affecting oral medications (such as inability to swallow, chronic diarrhea, and intestinal obstruction); 6. Have hypertension that cannot be well controlled after antihypertensive medication (systolic blood pressure >=140mmHg or diastolic blood pressure >= 90mmHg); 7. Have heart clinical symptoms or diseases that have not been well controlled, such as: (1) heart failure above NYHA2 grade; (2) unstable angina pectoris; (3) myocardial infarction occurred within 1 year; (4) supraventricular or ventricular arrhythmia of clinical significance requires treatment or intervention; 8. Abnormal coagulation function (PT>16s, APTT>43s, TT>21s, Fbg= 500 IU/ml), hepatitis c (hepatitis c antibody positive, and hcv-rna higher than the detection limit of the analytical method) or combined hepatitis b and c co-infection; 11. Live attenuated vaccine is scheduled to be administered within 4 weeks prior to first administration or during the study period; 12. Urine routine indicated that urine protein >= ++, or confirmed that urine protein content >= 1.0g at 24 hours; 13. Pregnant or lactating women; 14. Other conditions not considered suitable for inclusion by the researcher.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective remission rate (ORR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival (PFS);Overall surviva (OS);Disease control rate; | — |
Countries
China
Contacts
Public ContactLi Sun
Shandong Tumor Combat Research Institute
Outcome results
None listed