cervical cancer
Conditions
Interventions
experimental group:albumin-bound paclitaxel combined with PD-1 antibody
Sponsors
Peking University Cancer Hospital & Institute
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-75 years. 2. Patients histologically diagnosed with cervical cancer (including squamous cell carcinoma, adenocarcinoma, adenosquamous cell carcinoma); 3. Patients with cervical cancer who have experienced progressive disease or relapse after receiving standard treatment. 4. The radiological examination during screening confirms the presence of at least one measurable lesion evaluated according to the RECIST v1.1; 5. An Eastern Cooperative Oncology Group(ECOG) score of 0 or 1; 6. Life expectancy >= 12 weeks; 7. Adequate hepatic, renal, heart, and hematologic functions. Absolute Neutrophil Count(ANC) >= 1.5*10^9/L, Platelet (PLT) >= 100 *10^9/L, Hemoglobin(HGB) >= 90 g/L, total bilirubin within 1.5×the upper limit of normal (ULN), and serum transaminase 50%. 9. Voluntarily participate and have signed the informed consent form (ICF).
Exclusion criteria
Exclusion criteria: 1. Patients who have previously received albumin-bound paclitaxel or exposures to any anti-PD-1 antibody drugs; 2. Exposures to any anti-tumor drugs within 4 weeks; 3. Toxicity of previous anti-tumor therapy has not returned to level 0 or 1 (hair loss, peripheral neurotoxicity caused by chemotherapy 10mg/d)within 14 days before the first dose of anti-PD-1 antibody; 9. Active infections such as HIV/AIDS or other serious infectious diseases; 10. HBV DNA >= 104 copies /ml; 11. Any active autoimmune disease or history of autoimmune disease (including but not limit to interstitial pneumonia, hepatitis, enteritis, nephritis, hyperthyroidism, pituitary inflammation, vasculitis, uveitis). 12. Severe cardiovascular disease: unstable angina pectoris, myocardial infarction, grade III-IV cardiac insufficiency (NYHA standard), and peripheral vascular disease above 2 degrees within 6 months prior to enrollment; 13.Severe arrhythmia requiring drug control, QT interval >450msHypertension not well controlled (systolic bp > 150mmHg, diastolic bp > 100mmHg); 14. Abnormal thyroid function, and the use of drugs cannot maintain the thyroid function in the normal range; 15. Prior allogeneic stem cell transplantation or organ transplantation; 16. Live vaccines were administered within 4 weeks prior to enrollment; 17. A history of severe allergic reactions to humanized antibodies or fusion proteins; 18. Other conditions regimented at investigators' discretion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| DCR;DOR;PFS;OS; | — |
Countries
China
Contacts
Public ContactGao Min
Peking University Cancer Hospital & Institute
Outcome results
None listed