NCT06226350已完成2 期
An Open, Single-arm, Multicenter Phase II Trial of Efficacy and Safety of F520 Monotherapy in the Treatment of Advanced, Persistent, Recurrent, or Metastatic Cervical Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- Objective tumor response rate (ORR) assessed by RECIST1.1
研究概览
简要总结
This study was an open, single-arm, enriched, multicenter Phase II study.
详细描述
The trial was divided into screening period, treatment period and follow-up period. Participants entered the screening period after signing informed consent and met the inclusion criteria. Subjects who did not meet the exclusion criteria were treated with F520 monotherapy, intravenously, at 3mg/kg every 3 weeks until disease progression or intolerable toxicity or withdrawal for other reasons, for a maximum of 2 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged 18 years and above;
- •Cervical squamous cell carcinoma, adenosquamous cell carcinoma or adenocarcinoma confirmed by histopathology;
- •Patients with advanced (stage IVb) cervical cancer that is inoperable and/or radiotherapy-resistant, or patients with persistent, recurrent or metastatic cervical cancer that progresses after first-line or above chemotherapy;
- •According to RECIST1.1 criteria, subjects must have at least one measurable target lesion examined by enhanced CT and/or enhanced MRI (non-lymph node diameter ≥10mm, or lymph node lesion diameter ≥15mm);
- •Expected survival ≥3 months;
- •Those with 0-2 scores on the American Eastern Oncology Collaboration Group (ECOG) scale;
- •Those who agree to provide archived tumor tissue samples or fresh tissue samples;
- •The function of vital organs meets the following requirements (drugs with blood components and cell growth factors are not allowed to be used within 14 days before the first administration) :
- •Blood routine: Absolute neutrophil count ≥1.5×109/L; Platelet ≥75×109/L; Hemoglobin ≥90g/L; Liver function: TBIL≤1.5×ULN, ALT and AST≤2.5×ULN; If liver metastasis was present, TBIL≤3×ULN, ALT and AST≤5×ULN; Renal function: serum creatinine (Cr) ≤1.5×ULN; Thyroid stimulating hormone (TSH) in the normal range; If TSH is abnormal, free triiodothyronine (FT3) and free thyroxine (FT4) must be normal or abnormal without clinical significance.
- •International Normalized ratio (INR) ≤1.5×ULN and activated partial thromboplastin time (APTT) ≤1.5×ULN.
排除标准
- •Patients with specific pre-existing conditions such as active autoimmune disease, type 1 diabetes, hypothyroidism requiring hormone replacement, and severe mental illness;
- •a history of other malignancies within the last 3 years, except locally curable cancers (limited to basal cell or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the breast);
- •Patients with central nervous system metastasis with clinical symptoms;
- •Previously treated with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibodies or any other antibody or drug targeting T-cell co-stimulation or immune checkpoint pathways;
- •Immunosuppressive, systemic or local hormone therapy within 14 days prior to initial administration for immunosuppressive purposes (daily dose equivalent to prednisone > 10mg of systemic corticosteroid);
- •Active infection requiring systemic treatment or unexplained fever during screening or prior to initial dosing > 38.5℃ (according to the investigators' judgment, patients with fever caused by tumors could be included in the group);
- •Patients receiving systemic tumor therapy with radiotherapy, chemotherapy, hormone therapy, surgery, targeted therapy or antibody drugs within 4 weeks before the first dose; Those who had been treated with monoclonal antibody coupled radionuclides or cytotoxins within 10 weeks prior to initial administration; The toxicity of previous anti-tumor therapy did not return to ≤ grade 1 (except hair loss);
- •Those who have had previous organ transplantation or received autologous stem cell transplantation within 3 months before the first administration;
- •infected with active tuberculosis;
- •suffering from interstitial lung disease (except for interstitial lung disease caused by radiotherapy and chemotherapy and currently asymptomatic);
- •Active hepatitis;
- •HIV antibody positive;
- •have been treated with any other investigational drug/device within 4 weeks prior to initial dosing;
- •Have uncontrolled or severe cardiovascular disease, such as New York Heart Association (NYHA) Class II or above congestive heart failure, unstable angina, myocardial infarction and other cardiovascular disease within 6 months before the first dose; Difficult to control hypertension (systolic blood pressure ≥180mmHg and/or diastolic blood pressure ≥100mmHg);
- •Those who have a history of drug abuse or alcoholism within 6 months before the first dose;
- •Known patients with previous macromolecular protein preparations, or known anti-PD-1 /PD-L1 antibodies;
- •Those who received live attenuated vaccine within 4 weeks prior to the first dose (except inactivated influenza vaccines such as injectable seasonal influenza vaccine);
- •Pregnant or lactating women, women who planned to become pregnant during the study period and within 6 months after the last dose, and who did not wish to use a medically approved effective contraceptive method (such as an IUD or condom) during the trial period;
- •Those who were judged not suitable for inclusion by the researchers.
研究组 & 干预措施
F520 monotherapy
Experimental
干预措施: Recombinant Humanized Anti-PD-1 Monoclonal Antibody Injection (Drug)
结局指标
主要结局
Objective tumor response rate (ORR) assessed by RECIST1.1
时间窗: approximately 2 years
CR+PR
次要结局
未报告次要终点
研究者
研究点 (1)
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