Status:
UNKNOWN
Study of Anti-PD-1 Combined With Albumin-Bound Paclitaxel in Patients With Recurrent Cervical Cancer
Lead Sponsor:
Sun Yat-sen University
Conditions:
Recurrent Cervical Cancer
Eligibility:
FEMALE
18-75 years
Phase:
PHASE2
Brief 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 th...
Eligibility Criteria
Inclusion
- Voluntarily participate and have signed the informed consent form (ICF);
- Patients histologically diagnosed with cervical cancer ;
- 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.
- The radiological examination during screening confirms the presence of at least one measurable lesion evaluated according to the RECIST v1.1;
- An Eastern Cooperative Oncology Group(ECOG) score of 0 or 1;
- Life expectancy ≥ 3 months;
- 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
- Pathology confirmed with sarcoma components (including malignant mixed mullerian tumors, endometrial leiomyosarcoma, and endometrial stromal sarcoma);
- Patients who have previously received albumin-bound paclitaxel or exposures to any anti-PD-1 antibody drugs;
- Exposures to any anti-tumor drugs within 4 weeks;
- 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;
- 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);
- History of psychiatric drugs abuse and not be abstinent, or dysphrenia；
- Central nervous system diseases, including uncontrollable epilepsy and symptomatic brain metastases;
- 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;
- Severe arrhythmia requiring drug control, QT interval \>470ms；
- Active infections such as HIV/AIDS or other serious infectious diseases;
- 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);
- Receipt of live attenuated vaccination within 30 days prior to study entry;
- Other conditions regimented at investigators' discretion.
Key Trial Info
Start Date :
November 13 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2023
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT04341883
Start Date
November 13 2019
End Date
December 1 2023
Last Update
May 27 2022
Active Locations (1)
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1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060