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Clinical Trials in China / NCT05316935
Recruiting Phase 2/3

GnRHa + Letrozole in Non-obese Progestin-insensitive Endometrial Cancer and Atypical Hyperplasia Patients

NCT05316935 · tracked via the Priya Life Science China tracker
Sponsor
Xiaojun Chen
Phase
Phase 2/3
Started
2022-07-13
Last updated
2026-09-10

Condition(s) studied

Endometrial NeoplasmsAtypical Endometrial HyperplasiaProgesterone Resistance

Investigational drug(s) / intervention(s)

GnRHaLetrozole 2.5mgDiane-35MET

GnRHa: Gonadotropin-releasing hormone analogue, intramuscular injection of 3.75mg will be given every 4 weeks , and the maximum using courses will be 6.

Letrozole 2.5mg: 2.5mg po qd and no more than 24 weeks

Diane-35: Periodic use. Patients will receive one pill po qd for 21 days, and next period should be started after 7 days.

MET: 500mg po tid

Study summary

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.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
45 Years
Healthy volunteers
No
Inclusion Criteria: * 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: 1. Megestrol acetate ≥ 160 mg qd using, combined with Levonorgestrel Lntrauterine System (LNG-IUS) inserted or not 2. Medroxyprogesterone acetate ≥ 250 mg qd using, combined with LNG-IUS inserted or not 3. LNG-IUS inserted * Progestin-insensitive: 1. remained with stable disease after 7 months of progestin use 2. 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 Criteria: * 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 * 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)

Primary outcome measure(s)

Trial sites (2)

FacilityCityRegionStatus
Obstetrics and Gynecology Hospital, Fudan University Shanghai Shanghai Municipality Recruiting
Tenth People's Hospital of Tongji University Shanghai Shanghai Municipality Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05316935 on ClinicalTrials.gov ↗ ← All trials in China