NCT06055738招募中2 期
An Exploratory Clinical Study of Zimberelimab Combined With Albumin-bound Paclitaxel and Cisplatin in Neoadjuvant Treatment of Locally Advanced Cervical Cancer
Tang-Du Hospital1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2023年10月9日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Objective response rate (ORR)
研究概览
简要总结
This is a prospective, single arm, phase II clinical study to evaluate the efficacy and safety of Zimberelimab combined with albumin-bound paclitaxel and cisplatin as neoadjuvant therapy for locally advanced cervical cancer.
详细描述
This study will enroll patients with IB3 and IIA2 locally advanced cervical cancer who received three cycles of neoadjuvant Zimberelimab combined with albumin-bound paclitaxel and cisplatin to evaluate the efficacy and safety.
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
- •Voluntary participation in clinical research.
- •Age ≥18 years old, female.
- •Squamous cell carcinoma, adenocarcinoma or adenosquamous carcinoma of the cervix confirmed by histology/cytology.
- •Previously untreated locally advancedcervical cancer (2018 FIGO stage IB3, IIA2) .
- •At least one measurable lesion was suitable for target lesion according to RECIST v1.1 .
- •Within 14 days before the first treatment, the major organ functions were basically normal.
- •Eastern Cooperative Oncology Group (ECOG) performance status score 0-1;
- •Subjects agree to provide sufficient tumor tissue samples for PD-L1 expression detection;
- •If hepatitis B surface antigen (HBsAg) is positive and/or hepatitis B core antibody (HBcAb) is positive, hepatitis B virus DNA (HBV DNA) is detected, HBV DNA < 104 copies /ml or < 2000IU/mL can be enrolled. Or those who had received antiviral therapy for at least 4 weeks before the first dose of study drug and were willing to continue antiviral therapy during the study were eligible for enrollment. Those with HCV antibody positive should be excluded.
- •Subjects of childbearing age and their sexual partners agreed to consent to contraceptive use after signing an informed consent form, during treatment and for at least 6 months after the last dose of the study intervention.
排除标准
- •Patients with active autoimmune disease or a history of autoimmune disease.
- •Previous history of allogeneic hematopoietic stem cell transplantation or organ transplantation (except corneal transplantation).
- •Use of immunosuppressive drugs within 14 days prior to treatment, excluding nasal spray and inhaled corticosteroids or physiological doses of systemic steroids (i.e., not more than 10 mg/ day of prednisolone or another corticosteroid at the physiological dose of the drug).
- •Previous treatment with anti-PD-1 antibody, anti-PD-L1 antibody, anti-PD-L2 antibody, anti-CD137 antibody, or anti-lymphocyte antigen 4 (CTLA-4) antibody.
- •Arterial or venous thromboembolic events within the previous 6 months, including myocardial infarction, unstable angina, cerebrovascular accident, transient ischemic attack, pulmonary embolism, deep vein embolism or any other major thromboembolism, implantable venous access port or catheter-derived thrombosis, or superficial venous thrombosis. Except for patients with stable thrombus after conventional anticoagulant therapy, prophylactic use of low-dose low molecular weight heparin was allowed.
- •Previous history of gastrointestinal perforation, gastrointestinal fistula, genital fistula (such as vesicovaginal fistula, urethrovaginal fistula, vesicovaginal fistula, etc.); Patients were allowed if the perforation or fistula had been treated with diversion surgery, resection, or repair, and the disease was recovered or relieved as judged by the investigator.
- •Symptomatic congestive heart failure (New York Heart Association class II-IV) Arrhythmias with poorly controlled symptoms.
- •Active pulmonary tuberculosis, receiving anti-tuberculosis treatment.
- •Interstitial lung disease.
- •Severe infections that are active or poorly controlled clinically. Severe infection within 3 weeks before treatment, including but not limited to patients hospitalized for complications of infection, bacteremia, or severe pneumonia.
- •Central nervous system metastasis, leptomeningeal metastasis, spinal cord compression, or leptomeningeal disease.
- •Human immunodeficiency virus (HIV) infection, known syphilis infection.
- •Have received live vaccine within 4 weeks of the first use of the experimental drug, or plan to receive live vaccine during the study.
- •Known or suspected allergy to the trial drug or any drug related to the trial.
- •Pregnant or lactating women.
- •There were other conditions deemed by the investigator to be inappropriate for enrollment.
研究组 & 干预措施
Zimberelimab combined with albumin-bound paclitaxel and cisplatin
Experimental
Zimberelimab combined with albumin-bound paclitaxel and cisplatin in neoadjuvant treatment of locally advanced cervical cancer
干预措施: Zimberelimab (Drug)
Zimberelimab combined with albumin-bound paclitaxel and cisplatin
Experimental
Zimberelimab combined with albumin-bound paclitaxel and cisplatin in neoadjuvant treatment of locally advanced cervical cancer
干预措施: Albumin-bound Paclitaxel (Drug)
Zimberelimab combined with albumin-bound paclitaxel and cisplatin
Experimental
Zimberelimab combined with albumin-bound paclitaxel and cisplatin in neoadjuvant treatment of locally advanced cervical cancer
干预措施: Cisplatin (Drug)
结局指标
主要结局
Objective response rate (ORR)
时间窗: 3-4 months
Objective response rate based on RECIST v1.1, ORR was defined as the ratio of best complete response (CR) and partial response (PR) recorded from the start of treatment to the preoperative evaluation
次要结局
- Complete pathological response (pCR)(one year)
- Major Pathological Response (MPR)(one year)
- Overall survival (OS)(three years)
- Adverse Events(three years)
- R0 resection rate(one year)
- Event-free survival (EFS)(three years)
研究者
研究点 (1)
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