GnRHa + Letrozole in Obese Progestin-insensitive Endometrial Cancer Patients
Recruiting now · Phase 2/Phase 3
Conditions studied: Endometrial Neoplasms, Atypical Endometrial Hyperplasia, Progesterone Resistance, Obesity
In brief
To investigate the efficacy of GnRHa plus letrozole in obese progestin-insensitive EEC patients.
Key facts
- Study ID
- NCT06379113
- Run by
- Xiaojun Chen
- People needed
- 29
- Starts
- 2022-07-13
- Expected to finish
- 2027-03-30
- Last updated by the study team
- 2025-08-11
Who can join
Age: 18 and older, up to 45. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Have a confirmed initial pathological diagnosis based upon hysteroscopy: histologically prove well-differentiated EEC G1 without myometrial invasion
- BMI≥30kg/m2
- No signs of suspicious extrauterine involvement on enhanced magnetic resonance imaging (MRI) or enhanced computed tomography (CT) or ultrasound
- Using progestin, any of the following therapy, as first-line treatment:
- Megestrol acetate ≥ 160 mg qd using, combined with Levonorgestrel Lntrauterine System (LNG-IUS) inserted or not
- Medroxyprogesterone acetate ≥ 250 mg qd using, combined with LNG-IUS inserted or not
- LNG-IUS inserted
- Progestin-insensitive:
- remained with stable disease after 7 months of progestin use
- did not achieve CR after 10 months of progestin use
- Have a desire for remaining reproductive function or uterus
- Good compliance with adjunctive treatment and follow-up
You may not qualify if…
- Combined with severe medical disease or severely impaired liver and kidney function
- Pathologically confirmed as endometrial cancer with suspicious myometrial invasion or extrauterine metastasis
- Patients with other types of endometrial cancer or other malignant tumors of the reproductive system
- Patients with breast cancer or other hormone- dependent tumors or diseases that cannot be used with GnRHa or Letrozole
- Strong request for uterine removal or other conservative treatment
- Known or suspected pregnancy
- Acute severe disease such as stroke or heart infarction or a history of thrombosis disease
- Smoker(>15 cigarettes a day)
Where it is running
- Tenth People's Hospital of Tongji University — Shanghai, Shanghai Municipality, China (enrolling)
- Obstetrics and Gynecology Hospital, Fudan University — Shanghai, China (enrolling)
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.