PD-1 Inhibitor Combined With Progesterone Treatment in Early Stage Endometrial Cancer Patients Who Want to Preserve Fertility
试验速览
- 阶段
- 早期 1 期
- 入组人数
- 60
- 主要终点
- Pathologic complete remission rate of endometrial curettage tissues
研究概览
简要总结
We want to make a comparison of PD-1 inhibitor combined with progesterone versus progesterone alone in the treatment of early stage endometrial cancer patients who want to preserve fertility.
详细描述
Approximately 63,400 new cases of endometrial cancer are diagnosed annually in China. While the initial treatment for early-stage disease is surgical staging with lymphadenectomy, it is apparently inappropriate for young patients who want to preserve fertility. Currently the standardize treatment for these patients are high-dose progesterone, which will be effective in approximately 40~70% patients. Mirena have been used recently as a new available treatment option, however, no concrete evidence shows it is more effective than the traditional progesterone treatment.
PD-1 inhibitor has been utilized as a salvage treatment in many cancers including ovarian cancer, cervical cancer, lung cancer, gastric cancer and endometrial cancer. As endometrial cancer showed high microsatellite instability-high/deficient mismatch repair (MSI-H/dMMR) rates, it is assumed to be highly responsive to PD-1 inhibitor treatment. Published clinical trial results showed that PD-1 inhibitor treatment was effective in 6/24 late-stage endometrial cancer patients, with little or mild side effects. Here we want to investigate the efficacy of PD-1 inhibitor combined with progesterone in early stage endometrial cancer patients who want to preserve fertility.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Early endometrial cancer patients (cancer confined in the endometrium, endometrioid histology, G1-2)
- •Patients want to preserve fertility
- •Informed consent acquired
- •Age <18, >= 45
- •Eastern Cooperative Oncology Group (ECOG) performance status score <=1
- •Normal blood routine test
- •Normal hepatic and renal function
- •Normal thyroid function
- •Patients willing to accept three times of hysteroscopy: before treatment, 3 months after treatment, 6 months after treatment.
- •Pregnancy test negative before treatment
排除标准
- •Patients are receiving immune-checkpoint inhibitor therapy
- •Patients need or request to receive other anti-cancer drug treatment such as chemotherapy
- •Patients are allergic to immune-checkpoint inhibitor agents
- •Patients have abnormal blood routine test results or impaired hepatic and renal functions
- •Patients have a history of cardiovascular disease, including severe hypertension, frequent cardiac arrhythmia, history of myocardial infarction
- •Patients have a history of hepatitis B or hepatitis C infection, with detectable virus load
- •Severe obstructive lung disease
- •Autoimmune disease
- •Need to receive daily corticosteroid or other immune-inhibitory agents
- •Active tuberculosis patients
- •Patients have a history of other malignant tumors
- •Patients with acute infectious disease
研究组 & 干预措施
progesterone
Megestrol Acetate Tablets, 160mg, po, once a day.
干预措施: progesterone (Drug)
pd-1 inhibitor and progesterone
Toripalimab. 240mg intravenous injection, every 3 weeks, 4 times. Megestrol Acetate Tablets, 160mg, po, once a day.
干预措施: PD-1 inhibitor combined progesterone (Drug)
结局指标
主要结局
Pathologic complete remission rate of endometrial curettage tissues
时间窗: 6 months
Hysteroscopy was performed 6 months after treatment. If the pathological results are normal, it is considered to be complete remission
Pathologic partial remission rate of endometrial curettage tissues
时间窗: 6 months
Hysteroscopy was performed 6 months after treatment. If the pathological results showed hyperplasia, it is considered to be partial remission
次要结局
- pregnancy rate(up to 2 years after treatment)
- adverse effects(up to 1 year after treatment)
研究者
Xiaoping Wan
Dean, Professor
Shanghai First Maternity and Infant Hospital