PD-1 Inhibitor Combined With Progesterone Treatment in Fertility Sparing Therapy for Mismatch Repair-deficient Endometrial Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Complete remission (CR) rate
研究概览
简要总结
The objective of this study was to investigate the feasibility of a PD-1 inhibitor in combination with progesterone as a means of preserving fertility in patients with early-stage mismatch repair-deficient (MMRd) endometrial cancer who wish to preserve fertility.
详细描述
Endometrial cancer (EC) is a prevalent gynecological cancer with an escalating global incidence. The standard treatment for endometrial cancer is total hysterectomy and bilateral salpingo-oophorectomy. However, given the rising incidence of endometrial cancer in younger individuals and the the delay in the age of human reproduction, the conservation of endometrial cancer has garnered heightened attention. Clinical practice has demonstrated that high-dose progesterone can reverse the lesioned endometrium, thereby providing a rationale for the conservative treatment of early-stage endometrial cancer.
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 MMRd rates, it is assumed to be highly responsive to PD-1 inhibitor treatment. Previous literature has reported that the efficacy of progesterone therapy is limited in patients with a MMRd status.Here we want to investigate the feasibility 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
- 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 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Be between the ages of 18-45 years old;
- •Stage IA (FIGO 2009) ;
- •Confirmed diagnosis of endometrial adenocarcinoma G1-G2 based upon D&C or hysteroscopy;
- •Molecular classification of MMRd, determined by immunohistochemical (IHC) for MMR proteins and by the second generation sequencing (NGS) or microsatellite polymerase chain reaction (PCR);
- •With a strong desire for fertility preservation;
- •Sign the informed consent.
排除标准
- •Stage IB(FIGO 2009) and above；
- •Tumour differentiation of G3 or non-endometrioid adenocarcinoma；
- •Complicated with any other malignancy；
- •Contraindicated to conservative treatment or the use of pharmaceuticals.
- •Contraindications to pregnancy, or judged by the researcher to be unfit for pregnancy or delivery.
研究组 & 干预措施
PD-1 Inhibitor Combined With Progesterone Treatment
All participants
干预措施: Sintilimab or Pembrolizumab and medroxyprogesterone acetate (MPA)/ megestrol acetate (MA) (Drug)
结局指标
主要结局
Complete remission (CR) rate
时间窗: From start of treatment to trial completion, an average of 3 months
No endometrioid carcinoma or any proliferative lesion is found by pathology; imaging examination shows no evidence of a tumor
Time to CR
时间窗: From start of treatment to trial completion, an average of 3 months
Time to CR was calculated from the commencement of fertility-preserving treatment to the date of the initial hysteroscopic examination to confirm CR
次要结局
- Pregnancy rate(1 year after CR)
- Pathological biomarker(From the start of treatment to CR，including 3 months, 6 months, 9 months, and so forth.)
- CA125(From the start of treatment to trial completion，including 3 months, 6 months, 9 months, and so forth.)
- Adverse reactions(From the start of treatment to trial completion，including 3 months, 6 months, 9 months, and so forth.)
- Live birth rate(1 year after pregnancy)
- Recurrence rate(6 months, 1 year, 2 year, 3 year, 4 year, 5 year after CR)
研究者
Wang Jianliu
Vice-president of Peking University People's Hospital
Peking University People's Hospital