A Open-label, Single-arm, Multicentre, Phase Ⅱ Study of Evaluate Efficacy and Safety of Anti-PD-1 Combined With Albumin-Bound Paclitaxel in Patients With Recurrent Cervical Cancer

Sun Yat-sen University1 site in 1 country27 target enrollmentJanuary 13, 2020

ConditionsRecurrent Cervical Cancer

Interventionsanti-PD-1+Albumin-Bound Paclitaxel

Drugsanti-PD-1+Albumin-Bound Paclitaxel

Overview

Phase: Phase 2
Intervention: anti-PD-1+Albumin-Bound Paclitaxel
Conditions: Recurrent Cervical Cancer
Sponsor: Sun Yat-sen University
Enrollment: 27
Locations: 1
Primary Endpoint: Objective Response Rate(ORR)
Status: Completed
Last Updated: last month

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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 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.

Registry

clinicaltrials.gov

Start Date

January 13, 2020

End Date

April 26, 2024

Last Updated

last month

Study Type

Interventional

Study Design

Single Group

Sex

Female

Investigators

Sponsor

Sun Yat-sen University

Responsible Party

Principal Investigator

Xin Huang

Hospital Chief Physician，Professor

Sun Yat-sen University

Eligibility Criteria

Inclusion Criteria

•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 Criteria

•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;

Arms & Interventions

anti-PD-1

PD-1+albumin-bound paclitaxel

Intervention: anti-PD-1+Albumin-Bound Paclitaxel

Outcomes

Primary Outcomes

Objective Response Rate(ORR)

Time Frame: up to 2 years

Objective tumor response was defined as the proportion of patients whose tumor volume has been reduced to a predetermined value and can be maintained for more than 4 weeks, ie ORR=CR+PR.