A Single-arm, Open, Multicenter Phase II Trial to Evaluate the Efficacy and Safety of QL1706 in Patients With Recurrent or Metastatic Cervical Cancer
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- The Overall Response Rate (ORR) assessed by the Independent Image Review Board (IRC)
研究概览
简要总结
This is a single-arm, open-label, multicenter, phase II trial to evaluate the efficacy and safety of QL1706 in patients with recurrent or metastatic cervical cancer.
详细描述
This is a single-arm, open-label, multicenter, phase II trial to evaluate the efficacy and safety of QL1706 in patients with recurrent or metastatic cervical cancer who have failed at least first-line platinum-containing standard therapy.
The study was divided into screening period/baseline, treatment period, and post-treatment follow-up period. Efficacy evaluation and safety monitoring should be performed throughout the study.
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
- •The subject will participate voluntarily and sign the informed consent form.
- •Female, aged ≥18 years when signing the informed consent form.
- •Recurrent or metastatic cervical cancer (pathological types include squamous cell carcinoma, adenocarcinoma) which is not suitable for radical treatment such as surgery and radiotherapy.
- •At least one measurable lesion is needed.
- •The Eastern Collaborative Oncology Group (ECOG) physical status score was 0 or
- •Adequate reserves of organ function is needed.
排除标准
- •Active autoimmune disease.
- •Central nervous system (CNS) metastasis.
- •Concomitant diseases such as cardiovascular and cerebrovascular diseases.
- •Fistula of female genital tract.
- •Diseases for which systemic corticosteroids or other immunosuppressive agents are planned to be used during the study treatment.
- •Previous recipients of immune checkpoint inhibitors.
- •Received systemic antitumor drugs such as chemotherapy and targeted therapy within 4 weeks before the first use of the experimental drug; Received proprietary Chinese medicine with anti-tumor indications within 2 weeks before the first use of the experimental drug.
- •Received radical concurrent chemoradiotherapy or adjuvant chemoradiotherapy within 12 weeks before the first use of the investigational drug; Received palliative radiotherapy (e.g., reductive radiotherapy for pain or bleeding) or other local treatments (e.g., radiofrequency ablation, transarterial chemoembolization, etc.) within 2 weeks before the first use of the investigational drug.
- •History of immunodeficiency.
- •History of allogeneic hematopoietic stem cell transplantation or organ transplantation.
研究组 & 干预措施
QL1706 injection
The dosage of QL1706 is 5.0 mg/kg, and QL1706 is administered every 3 weeks (Q3W) by intravenous infusion
干预措施: QL1706 (Drug)
结局指标
主要结局
The Overall Response Rate (ORR) assessed by the Independent Image Review Board (IRC)
时间窗: Every 6 weeks, from the date of enrollment until the date of the last time that tumor imaging and assessment of disease has been done, assessed up to 2 years
The ORR assessed by the Independent Image Review Board (IRC) according to RECIST V1.1
次要结局
- Overall survival(From date of enrollment until the date of death from any cause or date of lost to visit, assessed up to 2 years after the last QL1706 injection has been administered.)
- The Overall Response Rate (ORR) assessed by the investigator according to RECIST V1.1(Every 6 weeks, from the date of enrollment until the date of the last time that tumor imaging and assessment of disease has been done, assessed up to 2 years)
- The Progression-free survival (PFS) assessed by the Independent Image Review Board (IRC) and the investigator(From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years after the last QL1706 injection has been administered.)
- The Disease Control Rate (DOR) assessed by the Independent Image Review Board (IRC) and the investigator(Every 6 weeks, from the date of enrollment until the date of the last time that tumor imaging and assessment of disease has been done, assessed up to 2 years)