NCT06128460尚未招募2 期
Adjuvant Chemoradiotherapy Followed by Zimberelimab for Locally Advanced Cervical Cancer (IB3, IIA2) Patients
Obstetrics & Gynecology Hospital of Fudan University0 个研究点目标入组 24 人开始时间: 2023年12月1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
- 尚未招募
- 发起方
- 入组人数
- 24
- 主要终点
- changes in tumor-related biomarkers
研究概览
简要总结
Locally advanced cervical cancer (stage IB3, IIA2) patients with postoperative risk factors need better treatment. We initiated a clinical study to explore the effectiveness of adjuvant chemoradiotherapy followed by Zimberelimab for these patients.
详细描述
For cervical cancer, although clinical research on PD-1 monoclonal antibodies was launched relatively late, the research results so far show that PD-1 monoclonal antibodies combined with chemotherapy have a high clinical effectiveness and a relatively high efficacy in the treatment of advanced/recurrent cervical cancer. Good security. However, there is currently a lack of clinical evidence for the use of PD-1 monoclonal antibodies combined with chemoradiotherapy in the treatment of high-risk patients after cervical cancer surgery. Therefore, this study intends to explore the clinical efficacy of postoperative adjuvant radiochemotherapy followed by PD-1 monoclonal antibody in the treatment of high-risk patients with locally advanced (IB3, IIA2) cervical cancer after surgery, and provide a new solution for clinical treatment.
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 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed cervical squamous cell carcinoma, cervical adenocarcinoma, or cervical adenosquamous carcinoma;
- •According to FIGO2018 staging, patients with locally advanced cervical cancer (IB3, IIA2) who require concurrent radiotherapy and chemotherapy;
- •Patients with radical surgery for cervical cancer;
- •Female patients: 18-70 years old;
- •ECOG physical condition score: 0~1 point;
- •Subjects have not received previous immunotherapy;
- •Expected survival ≥6 months;
- •Women of reproductive age should agree to use contraceptives (such as Iuds, contraceptives, or condoms) during the study period and for 6 months after the study ends; Have a negative serum or urine pregnancy test within 7 days prior to study enrollment and must be a non-lactating patient;
- •For adequate organ function as defined in the protocol, test samples must be collected within 7 days prior to initiation of the study therapy
- •Subjects voluntarily joined the study, signed informed consent, had good compliance, and cooperated with follow-up.
排除标准
- •Subjects have histological subtypes other than those permitted by inclusion criteria;
- •Severe hypersensitivity to cepalizumab and/or any of its excipients (≥ grade 3);
- •Participate in or have participated in other clinical trials within 4 weeks before enrollment;
- •Have received or will receive inactivated vaccine within 30 days prior to the first study treatment;
- •Received a combination of systemic immune stimulants, colony-stimulating factors, interferon, interleukin, and vaccine within 6 weeks or 5 half-lives (if shorter) prior to initial administration;
- •Have been diagnosed with an immune deficiency or are receiving chronic systemic steroid therapy (doses greater than 10mg daily equivalent of prednisone) or any other form of immunosuppressive therapy within 7 days prior to the first dose;
- •Have an active autoimmune disease in the past 2 years that requires systemic treatment (such as the use of disease-modulating drugs, corticosteroids, or immunosuppressive drugs);
- •Have a history of (non-infectious) pneumonia requiring steroid treatment or have a current (non-infectious) pneumonia;
- •An active infection requiring systematic treatment;
- •Known history of HIV infection;
- •A known history of hepatitis B (defined as HBsAg reactive) or known active hepatitis C virus (defined as detection of HCV RNA[qualitative]) infection;
- •Known active tuberculosis (TB; Tuberculosis) medical history;
- •Has received allogeneic tissue/solid organ transplantation;
- •Suffering from central nervous system metastases such as brain metastases;
- •Patients with uncontrolled chest and abdominal fluid;
- •Patients with mobility disorders such as pathological fractures caused by tumor bone metastasis;
- •Insufficient hematopoietic function of bone marrow;
- •Abnormal liver;
- •Abnormal kidney;
- •Bleeding risk;
- •Cardiovascular and cerebrovascular abnormalities.
研究组 & 干预措施
Concurrent themoradiotherapy Followed by Zimberelimab
Experimental
- Radiotherapy: Intensity modulated conformal radiation therapy (IMRT) is used for external irradiation, and the pelvic target volume dose (PTV) is: 45-50 Gy/1.8Gy/25-28f; the stump margin is positive, and after the external irradiation is completed, Additional CT-guided three-dimensional conformal brachytherapy, HR-CTV: 24--30Gy/4-5f.
- Concurrent chemotherapy: performed during external radiotherapy. Starting from the first week of radiochemotherapy, cisplatin 40 mg/m2 was given. Chemotherapy is given every 7 days, up to 5-6 times;
- Zimberelimab injection: 240 mg/time, intravenous infusion, administered every 21 days, starting within four weeks after completing concurrent chemoradiotherapy, and maintained for 8 cycles
干预措施: Zimberelimab (Drug)
Concurrent themoradiotherapy Followed by Zimberelimab
Experimental
- Radiotherapy: Intensity modulated conformal radiation therapy (IMRT) is used for external irradiation, and the pelvic target volume dose (PTV) is: 45-50 Gy/1.8Gy/25-28f; the stump margin is positive, and after the external irradiation is completed, Additional CT-guided three-dimensional conformal brachytherapy, HR-CTV: 24--30Gy/4-5f.
- Concurrent chemotherapy: performed during external radiotherapy. Starting from the first week of radiochemotherapy, cisplatin 40 mg/m2 was given. Chemotherapy is given every 7 days, up to 5-6 times;
- Zimberelimab injection: 240 mg/time, intravenous infusion, administered every 21 days, starting within four weeks after completing concurrent chemoradiotherapy, and maintained for 8 cycles
干预措施: Platinum (Drug)
Concurrent themoradiotherapy Followed by Zimberelimab
Experimental
- Radiotherapy: Intensity modulated conformal radiation therapy (IMRT) is used for external irradiation, and the pelvic target volume dose (PTV) is: 45-50 Gy/1.8Gy/25-28f; the stump margin is positive, and after the external irradiation is completed, Additional CT-guided three-dimensional conformal brachytherapy, HR-CTV: 24--30Gy/4-5f.
- Concurrent chemotherapy: performed during external radiotherapy. Starting from the first week of radiochemotherapy, cisplatin 40 mg/m2 was given. Chemotherapy is given every 7 days, up to 5-6 times;
- Zimberelimab injection: 240 mg/time, intravenous infusion, administered every 21 days, starting within four weeks after completing concurrent chemoradiotherapy, and maintained for 8 cycles
干预措施: radiotherapy (Radiation)
结局指标
主要结局
changes in tumor-related biomarkers
时间窗: 3 years
changes of tumor- related biomarkers (T cell receptor library profile and peripheral blood ctDNA content analysis)
次要结局
- OS(5 years)
- DFS(2 years)
- AE(3 years)
研究者
Keqin Hua
Director of Gynecological Oncology
Obstetrics & Gynecology Hospital of Fudan University
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