Status:
NOT_YET_RECRUITING
PD-1 Inhibitor Combined With Progesterone Treatment in FST for Patients With MMRd Endometrial Cancer
Lead Sponsor:
Peking University People's Hospital
Collaborating Sponsors:
Peking Union Medical College Hospital
Peking University Third Hospital
Conditions:
Endometrial Cancer
Endometrioid Carcinoma
Eligibility:
FEMALE
18-45 years
Phase:
NA
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-defi...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2029
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT06549855
Start Date
October 1 2024
End Date
October 1 2029
Last Update
August 12 2024
Active Locations (1)
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1
Peking University People's Hospital
Beijing, Beijing Municipality, China