PD-1 Inhibitor Combined With Progesterone Treatment in FST for Patients With MMRd Endometrial Cancer
NCT ID: NCT06549855
Last Updated: 2024-08-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
10 participants
INTERVENTIONAL
2024-10-31
2029-10-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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PD-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
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
45 Years
FEMALE
No
Sponsors
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Peking Union Medical College Hospital
OTHER
Peking University Third Hospital
OTHER
Huazhong University of Science and Technology
OTHER
Tianjin Medical University
OTHER
Shandong University
OTHER
Shengjing Hospital
OTHER
Beijing Chao Yang Hospital
OTHER
Peking University People's Hospital
OTHER
Responsible Party
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Wang Jianliu
Vice-president of Peking University People's Hospital
Principal Investigators
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Jianliu Wang, Professor
Role: STUDY_CHAIR
Peking University People's Hospital
Locations
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Peking University People's Hospital
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Jianliu Wang
Role: primary
Other Identifiers
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2024MMRdECFerSp
Identifier Type: -
Identifier Source: org_study_id
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