Tests GnRHa with letrozole in non-obese women with early endometrial cancer
Compares GnRHa plus letrozole with Diane-35 plus metformin in women with early endometrial cancer.
Plain-language title generated from the registry record
Registry title: GnRHa + Letrozole in Non-obese Progestin-insensitive Endometrial Cancer and Atypical Hyperplasia Patients
Key facts
- Where
- Shanghai, ChinaSee the 2 sites
- Phase
- Phase 2/3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 45 years old?
Source: NCT05316935, who can take part
Where in China
- Obstetrics and Gynecology Hospital, Fudan UniversityShanghai, ChinaTaking people
- Tenth People's Hospital of Tongji UniversityShanghai, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Xiaojun Chen
- Trial code
- NCT05316935
- Record updated
- 10 September 2026
- Original description
To investigate the efficacy of GnRHa plus letrozole vs Diane-35 plus metformin in non-obese progestin-insensitive early-stage endometrial cancer (EEC) and atypical hyperplasia(EAH) patients asking for conservative treatment.Read full original descriptionShow less
Gonadotropin-releasing Hormone Agonist (GnRHa) Plus Letrozole in Non-obese Progestin-insensitive Early-stage Endometrial Cancer and Atypical Hyperplasia Patients With Conservative Treatment
To investigate the efficacy of GnRHa plus letrozole vs Diane-35 plus metformin in non-obese progestin-insensitive early-stage endometrial cancer (EEC) and atypical hyperplasia(EAH) patients asking for conservative treatment.
Inclusion: Have a confirmed initial pathological diagnosis based upon hysteroscopy: histologically prove EAH or 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.
Exclusion: 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 Diane-35, GnRHa, Letrozole or MET; Acute severe disease such as stroke or heart infarction or a history of thrombosis disease; Strong request for uterine removal or other conservative treatment; Known or suspected pregnancy; Smoker(>15 cigarettes a day).