cervical cancer
Conditions
Interventions
one-arm:Carrelizumab + albumin-bound paclitaxel + nedaratin
Sponsors
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 70 years; 2. The first-line standard treatment regimen recommended by the NCCN guidelines has been used for progressive or recurrent cervical cancer confirmed by histology, cytology or imaging, or stage IVB cervical cancer confirmed by histology, cytology or imaging; 3. According to iRECIST standard, the patient has at least one target lesion with measurable diameter line; 4. ECOG PS 0-2; 5. The functions of vital organs meet the following requirements: (1) Absolute count of neutrophils (ANC) >= 1.5x10^9/L; (2) Platelet >= 100 x 109/L; (3) Hemoglobin >= 90g/L; (4) Bilirubin = 50mL/min; (6) Normal thyroid function; 6. Hepatitis B surface antigen (HBsAg) (-) and hepatitis B core antibody (HBcAb) (-).If HBsAg (+) or HBcAb (+), HBV DNA must be = 3 months; 9. Fertile female subjects shall undergo a urine or serum pregnancy test within 72 hours of receiving the first study drug and prove negative, and shall be willing to use at least one contraceptive method during the trial period until 3 months after the last administration of Carrelizumab and at least 6 months after the last chemotherapy; 10. Patients volunteer to participate in this study and sign informed consent (ICF), with good compliance and follow-up.
Exclusion criteria
Exclusion criteria: 1. Other active malignancies within 5 years or at the same time.Localized curable tumors, such as basal cell carcinoma, squamous cell carcinoma, superficial bladder carcinoma, and carcinoma in situ of the breast, were included. 2. Patients who are about to undergo or have previously received an organ or bone marrow transplant. 3. There is uncontrolled pleural effusion, pericardial effusion, or ascites that require repeated drainage. 4. Central nervous system (CNS) or pia meningeal metastases confirmed by imaging or pathological examination. 5. Cerebrovascular accidents, myocardial infarction, unstable angina, and poorly controlled arrhythmias (including QTc interphase >= 470 ms) occurred within 6 months prior to the first administration (QTc interphase calculated by the Fridericia formula); 6. III ~ IV level cardiac insufficiency according to the NYHA standard or echocardiography shows LVEF (left ventricular ejection fraction) 10mg/ day prednisone or other therapeutic hormones) for immunosuppression purposes; 12. Received live vaccine or attenuated vaccine within 28 days before the first administration;However, inactivated viral vaccines for seasonal influenza are permitted; 13. Underwent major surgery within 28 days prior to the first medication.In this study, major surgeries were defined as those that required at least 3 weeks of postoperative recovery time before they could receive the treatment in this study; 14. Received radiotherapy within 28 days prior to the first administration, except palliative radiotherapy for bone lesions within 7 days prior to the first administration; 15. AE caused by radiotherapy did not recover to CTCAE V5.02.0, PT >16s), bleeding tendency or ongoing thrombolytic or anticoagulant therapy, prophylactic use of low-dose aspirin, low molecular weight heparin is permitted; 19. There were clinically significant bleeding symptoms or definite bleeding tendency within 3 months before enrollment; 20. The patient had active infection, unexplained fever >= 38.5 degree C within 7 days before medication, or white blood cell count >15x10^9/L at baseline; 21. Patients who received any T cell co-stimulation or immune checkpoint therapy, including but not limited to cytotoxic T lymphocyte-associated antigen-4 (CTLA-4) inhibitors, programmed death receptor 1 (PD-1) inhibitors, PD-L1/2 inhibitors, or other t-cell-targeted drugs previously; 22. Patients who is participating in other clinical studies, or begin treatment in this study less than 2 weeks from the end of drug therapy in the previous clinical study; 23. The fol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| PFS;OS;DCR;AE; | — |
Countries
China
Contacts
Public ContactWang Changyu
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Outcome results
None listed