cervical cancer
Conditions
Interventions
case group:Nil
Sponsors
Shanxi Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Patients with advanced cervical cancer diagnosed by pathology; 2. Age >=18; 3. At least one measurable lesion is present according to the efficacy evaluation criteria for solid tumors (RECIST 1.1); 4.ECOG: 0-2; 5. Expected survival >=12 weeks; 6. The function of vital organs meets the following requirements (no blood components or cell growth factors are recommended for the first 2 weeks of study treatment): (1) Absolute count of neutrophils (ANC) >=1.5x10^9/L; (2) Platelet >=100x10^9/L; (3) Hemoglobin >=9g/dL; (4) Serum albumin >=2.8g/dL; (5) bilirubin =50mL/min; (7) Activated partial thromboplastin time (APTT) and international standardized ratio (INR) <1.5 ULN (for stable dose anticoagulant therapy such as low molecular weight heparin or warfarin and INR can be screened within the expected therapeutic range of anticoagulants); 7. Women of childbearing age must have a negative pregnancy test (ßHCG) before starting treatment, and women and men of childbearing age (who have sexual relations with women of childbearing age) must agree to the uninterrupted use of effective contraceptives during treatment and for 6 months after the last therapeutic dose; 8. Subjects voluntarily participate in this study, sign informed consent, good compliance, and cooperate with follow-up; 9. The investigators determined that patients were eligible for combination therapy with carrilizumab.
Exclusion criteria
Exclusion criteria: 1. Subjects have any active autoimmune diseases or a history of autoimmune diseases (not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, pituitaritis, vasculitis, nephritis, hyperthyroidism, hypothyroid function; subjects with vitiligo or asthma that had been in complete remission during childhood were enrolled as adults without any intervention; asthmatic subjects requiring bronchodilators for medical intervention were not included); 2. Have used anti-PD-1 antibody, anti-CTLA-4 antibody, TCR-T, CAR-T and other immunotherapy, or participated in clinical trials of other antitumor drugs within 4 weeks prior to first administration; or within 4 weeks prior to first administration or scheduled to receive live attenuated vaccine during the study period; 3. Advanced patients with symptoms that have spread to the viscera and are at risk of life-threatening complications in the short term (including patients with uncontrolled large exudate, pulmonary lymphangitis and more than 30% liver involvement); 4. Radiological evidence (CT or MRI) of a central tumor with invasion of local large vessels, clinically significant hemoptysis in the past 3 months; 5. Receive anticoagulants or antiplatelet drugs, abnormal coagulation function (INR> 1.5ULN, APTT> 1.5ULN), with bleeding tendency; severe thrombus or clinically related severe bleeding events in the past 6 months; predisposition to hereditary bleeding or thrombosis; 6. Patients with uncontrolled cardiac clinical symptoms or diseases, such as : (1) NYHA Grade II or above heart failure; (2) Unstable angina pectoris; (3) Previous myocardial infarction within 1 year; (4) Clinically significant supraventricular or ventricular arrhythmias requiring clinical intervention; 7. A known history or evidence of interstitial lung disease or active non-infectious pneumonia; 8. Patients with congenital or acquired immunodeficiency (such as HIV-infected persons), active hepatitis B (HBV-DNA2000 IU/mL or >= 104 copies /mL) or hepatitis C (HCV-RNA is positive and HCV-RNA is above the detection limit of the assay method); 9. Has a known allergy to macromolecular protein preparations, or to any carrizumab ingredient, or has allergic reactions, hypersensitivities, or contraindications to any ingredient used in apatinib; 10. There are many factors that affect the absorption of oral drugs, such as inability to swallow, nausea and vomiting, chronic diarrhea and intestinal obstruction; 11. Major surgery or significant trauma within 28 days before enrollment; 12. Subjects requiring systematic treatment with corticosteroid (> 10mg/ day equivalent dose) or other immunosuppressant within 14 days prior to initial use of the study drug; 13. Previous antitumor toxicity does not recover to 140 mmHg, diastolic blood pressure >90 mmHg); 16. As determined by the Investigator, subjects have other factors that may cause them to be forced to terminate the study, such as other serious illnesses (including mental illness) requiring combined treatment, serious abnormal laboratory test values, family or social factors that may affect the safety of subjects or the collection of study data.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression free survival; | — |
Countries
China
Contacts
Public ContactRen Junli
Shanxi Cancer Hospital
Outcome results
None listed