Clinical trial NCT04341883: Study of Anti-PD-1 Combined With Albumin-Bound Paclitaxel in Patients With Recurrent Cervical Cancer
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Recurrent Cervical Cancer
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2020-04-10
Enrollment: 27
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Objective Response Rate(ORR)
timeFrame: up to 2 years
Secondary outcomes:
measure: Progression Free Survival(PFS)
timeFrame: up to 2 years
measure: Overall Survival(OS)
timeFrame: up to 2 years
measure: Disease Control Rate(DCR)
timeFrame: up to 2 years
measure: Duration of Response(DoR)
timeFrame: up to 2 years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
Study officials:
References: