NCT04150575Unknown2 期
A Single-Arm, Open-Label, Multicentre, Phase II Clinical Study to Evaluate Efficacy and Safety of HLX10 (Recombinant Humanized Anti-PD-1 Monoclonal Antibody Injection) Combined With Albumin-Bound Paclitaxel in Patients With Advanced Cervical Cancer Who Have Progressive Disease or Intolerable Toxicity After First-Line Standard Chemotherapy
Shanghai Henlius Biotech1 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2020年3月10日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- ORR
研究概览
简要总结
This is a single-arm, open-label, multicentre, phase II clinical study.Subjects can only enter this study after they meet the inclusion and exclusion criteria.All enrolled patients will receive the treatment with HLX10 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 HLX10 for up to 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 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Voluntarily participate and have signed the informed consent form (ICF);
- •Aged ≥ 18 years and ≤ 75 years at the time of signing the ICF
- •Patients histologically or cytologically diagnosed with cervical cancer (pathology report is required and pathological types are cervical squamous cell carcinoma, adenocarcinoma, and adenosquamous carcinoma).
- •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. First-line chemotherapy includes any of the following:
- •Platinum-based drugs + taxanes;
- •Platinum-based drugs + topotecan;
- •Taxanes + topotecan.
- •The radiological examination during screening confirms the presence of at least one measurable lesion evaluated according to the RECIST v1.1(IRRC).
- •Patients whose tumour specimens are tested positive for PD-L1 expression (CPS ≥ 1).
- •An ECOG score of 0 or
- •Conforming to laboratory measurements;
排除标准
- •Patients who have previously received albumin-bound paclitaxel.
- •Patients with other active malignancies within 5 years or at the same time.
- •Patients who are preparing for or have received an organ or bone marrow transplant.
- •Presence of uncontrollable pleural effusion, pericardial effusion, or ascites requiring repeated drainage.
- •Central nervous system (CNS) or leptomeningeal metastases confirmed by imaging or pathological examination.
- •Class III to IV cardiac insufficiency according to NYHA classification or an LVEF (left ventricular ejection fraction) < 50% by cardiac colour Doppler.
- •8.With human immunodeficiency virus (HIV) infection. 9.With active pulmonary tuberculosis. 10.Have received any T-cell costimulatory or immune checkpoint therapy, including but not limited to cytotoxic T lymphocyte-associated antigen-4 (CTLA-4) inhibitors, PD-1 inhibitors, PD-L1/2 inhibitors, or other agents that target T cells.
研究组 & 干预措施
HLX10
Experimental
HLX10+albumin-bound paclitaxel
干预措施: HLX10+Albumin-Bound Paclitaxel (Drug)
结局指标
主要结局
ORR
时间窗: up to 2 years
Objective response rate(assessed by independent radiological review committee (IRRC) based on the RECIST Version 1.1)
次要结局
- 6-month PFS rate(from the first dose until firstly confirmed and recorded disease progression or death (whichever occurs earlier),assessed up to 6 months)
- ORR(up to 2 years)
- PFS(from the first dose until firstly confirmed and recorded disease progression or death (whichever occurs earlier),assessed up to 2 years)
- OS(from the date of first dose until the date of death from any cause，assessed up to 2 years)
- 6-month OS rate(from the date of first dose until the date of 6-month)
研究者
研究点 (1)
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