study of anti-pd-1 combined with albumin-bound paclitaxel in patients with recurrent cervical cancer

Conditions: Recurrent Cervical Cancer

Summary: this is an open-label, single-arm, phase ii, multi-center clinical trial. subjects can only enter this study after they meet the inclusion and exclusion criteria. all enrolled patients will receive the treatment with anti-pd-1 combined with albumin-bound paclitaxel, every 3 weeks, until progressive disease, initiation of new anti-tumour therapy, death, intolerable toxicity. albumin-bound paclitaxel may be used for up to 6 cycles and anti-pd-1 for up to 2 years.


Eligibility criteria:
inclusion criteria: 1. voluntarily participate and have signed the informed consent form (icf); 2. patients histologically diagnosed with cervical cancer ; 3. patients with advanced cervical cancer who have experienced progressive disease or relapse after receiving standard treatment (first-line chemotherapy must be included) or who are intolerant to first-line chemotherapy. 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 ≥ 3 months; 7. adequate hepatic, renal, heart, and hematologic functions. absolute neutrophil count(anc) ≥ 1.5×109/l, platelet (plt) ≥ 70×109/l, hemoglobin(hgb) ≥ 80 g/l, total bilirubin within 1.5×the upper limit of normal (uln), and serum transaminase≤2.5×upper limit of normal(uln), serum creatine ≤ 1.5 x upper limit of normal(uln), creatinine clearance rate ≥50ml/min, international normalized ratio\<1.5 x upper limit of normal(uln), urinary protein≤（+）and thyroid stimulating hormone≤ 1.5 x upper limit of normal(uln). exclusion criteria: 1. pathology confirmed with sarcoma components (including malignant mixed mullerian tumors, endometrial leiomyosarcoma, and endometrial stromal sarcoma); 2. patients who have previously received albumin-bound paclitaxel or exposures to any anti-pd-1 antibody drugs; 3. exposures to any anti-tumor drugs within 4 weeks; 4. current or prior use of any immunosuppressive medication or systemic hormone therapy（which are not to exceed 10 mg/day of prednisone, or an equivalent corticosteroid prednisone\>10mg/d）within 14 days before the first dose of anti-pd-1 antibody; 5. any primary malignancy within 5 years (except for fully treated in situ malignant such as breast cancer, bladder cancer, cervical carcinoma in situ, cutaneous basal cell carcinoma or squamous cell carcinoma); 6. history of psychiatric drugs abuse and not be abstinent, or dysphrenia； 7. central nervous system diseases, including uncontrollable epilepsy and symptomatic brain metastases; 8. 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; 9. severe arrhythmia requiring drug control, qt interval \>470ms； 10. active infections such as hiv/aids or other serious infectious diseases; 11. any active autoimmune disease or history of autoimmune disease (including but not limit to autoimmune hepatitis, interstitial pneumonia, hepatitis, enteritis, nephritis, hyperthyroidism, pituitary inflammation, vasculitis, uveitis) . patients need receiving systemic hormonal therapy and/or immunosuppressive therapy (eg asthma requiring bronchodilators); 12. receipt of live attenuated vaccination within 30 days prior to study entry; 13. other conditions regimented at investigators' discretion.