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Clinical Trial NCT06549855 for Endometrial Cancer, Endometrioid Carcinoma, Mismatch Repair Deficiency is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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PD-1 Inhibitor Combined With Progesterone Treatment in FST for Patients With MMRd Endometrial Cancer 10
Clinical Trial NCT06549855 is an interventional study for Endometrial Cancer, Endometrioid Carcinoma, Mismatch Repair Deficiency and is currently not yet recruiting. Enrollment is planned to begin on October 1, 2024 and continue until the study accrues 10 participants. Led by Peking University People's Hospital, this study is expected to complete by October 1, 2029. The latest data from ClinicalTrials.gov was last updated on August 12, 2024.
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 pr...Show More
Official Title
PD-1 Inhibitor Combined With Progesterone Treatment in Fertility Sparing Therapy for Mismatch Repair-deficient Endometrial Cancer
Conditions
Endometrial CancerEndometrioid CarcinomaMismatch Repair DeficiencyOther Study IDs
- 2024MMRdECFerSp
NCT ID Number
Start Date (Actual)
2024-10
Last Update Posted
2024-08-12
Completion Date (Estimated)
2029-10
Enrollment (Estimated)
10
Study Type
Interventional
PHASE
N/A
Status
Not yet recruiting
Keywords
Fertility preservation
Endometrioid Carcinoma
PD-1 inhibitor
Endometrioid Carcinoma
PD-1 inhibitor
Primary Purpose
Treatment
Design Allocation
N/A
Interventional Model
Single Group
Masking
None (Open Label)
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalPD-1 Inhibitor Combined With Progesterone Treatment All participants | Sintilimab or Pembrolizumab and medroxyprogesterone acetate (MPA)/ megestrol acetate (MA) 1. Sintilimab or Pembrolizumab 200mg intravenous injection, every 3 weeks
2. MA, 320mg/MPA, 500mg, po, once a day |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Complete remission (CR) rate | No endometrioid carcinoma or any proliferative lesion is found by pathology; imaging examination shows no evidence of a tumor | From start of treatment to trial completion, an average of 3 months |
Time to CR | Time to CR was calculated from the commencement of fertility-preserving treatment to the date of the initial hysteroscopic examination to confirm CR | From start of treatment to trial completion, an average of 3 months |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Recurrence rate | After complete remission, there is evidence of recurrence in pathology, and the imaging examination shows that the lesion recurrences. | 6 months, 1 year, 2 year, 3 year, 4 year, 5 year after CR |
Pregnancy rate | A pregnancy test shows pregnancy after CR. | 1 year after CR |
Live birth rate | The live birth rate is defined as the ratio of live births to pregnancies. | 1 year after pregnancy |
Pathological biomarker | pathological markers(such as Ki-67, estrogen receptor, progesterone receptor, p53, PTEN, MLH1, PMS2, MSH2, and MSH6) at each hysteroscopy | From the start of treatment to CR，including 3 months, 6 months, 9 months, and so forth. |
CA125 | Used as a tumor marker for disease monitoring | From the start of treatment to trial completion，including 3 months, 6 months, 9 months, and so forth. |
Adverse reactions | Any unfavorable response resulting from the administration of any pharmaceutical agent utilized as part of the therapeutic regimen. | From the start of treatment to trial completion，including 3 months, 6 months, 9 months, and so forth. |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult
Minimum Age
18 Years
Eligible Sexes
Female
- 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.
- 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.
Peking University People's HospitalStudy Responsible Party
Wang Jianliu, Principal Investigator, Vice-president of Peking University People's Hospital
Study Central Contact
Contact: Jianliu Wang, Professor, 0086-010-88324381, [email protected]
Contact: Yiqin Wang, [email protected]
1 Study Locations in 1 Countries
Beijing Municipality
Peking University People's Hospital, Beijing, Beijing Municipality, China
Jianliu Wang, Contact