Clinical trial · Interventional
PD-1 Inhibitor Combined With Progesterone Treatment in FST for Patients With MMRd Endometrial Cancer
PD-1 Inhibitor Combined With Progesterone Treatment in Fertility Sparing Therapy for Mismatch Repair-deficient Endometrial Cancer
NCT06549855CI-TRIAL-00121178recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Endometrial Cancer | Malignant Endometrial Neoplasm | CURATED_BROADER | 0.80 |
| Endometrioid Carcinoma | Endometrioid Adenocarcinoma | ALIAS | 0.90 |
| Mismatch Repair Deficiency | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Sintilimab or Pembrolizumab and medroxyprogesterone acetate (MPA)/ megestrol acetate (MA) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- PD-1 Inhibitor Combined With Progesterone Treatment
- description
- All participants
- interventionNames
- Drug: Sintilimab or Pembrolizumab and medroxyprogesterone acetate (MPA)/ megestrol acetate (MA)
Primary outcomes (2)
- measure
- Complete remission (CR) rate
- timeFrame
- From start of treatment to trial completion, an average of 3 months
- description
- No endometrioid carcinoma or any proliferative lesion is found by pathology; imaging examination shows no evidence of a tumor
- measure
- Time to CR
- timeFrame
- From start of treatment to trial completion, an average of 3 months
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 45 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.