PD-1 Inhibitor Combined With Progesterone Treatment in Fertility Sparing Therapy for Mismatch Repair-deficient Endometrial Cancer
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Complete remission (CR) rate
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Arms & Interventions
PD-1 Inhibitor Combined With Progesterone Treatment
All participants
Intervention: Sintilimab or Pembrolizumab and medroxyprogesterone acetate (MPA)/ megestrol acetate (MA) (Drug)
Outcomes
Primary Outcomes
Complete remission (CR) rate
Time Frame: 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
Time Frame: 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
Secondary Outcomes
- Live birth rate(1 year after pregnancy)
- 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.)
- Recurrence rate(6 months, 1 year, 2 year, 3 year, 4 year, 5 year after CR)
Investigators
Wang Jianliu
Vice-president of Peking University People's Hospital
Peking University People's Hospital