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Endometrial NeoplasmsPhase 2/3NCT05316935

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

A Phase 2/3 study testing GnRHa, Letrozole 2.5mg and Diane-35 in people with Endometrial Neoplasms and Atypical Endometrial Hyperplasia, run by Xiaojun Chen at 2 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 45 years, women only
What is being tested?
GnRHa, Letrozole 2.5mg and Diane-35
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
2 sitesChina
Study dates
13 Jul 2022to 30 Mar 2028
Phase
Phase 2/3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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
Show all 12Show fewer
  • 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

Who cannot join

  • 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)

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Xiaojun Chen, PhD contact

8602133189900 ext. 6429

cxjlhjj@163.com

Bingyi Yang contact

8602133189900 ext. 6429

xiaomihaoku@163.com

China2 sites, 2 recruiting

  • Obstetrics and Gynecology Hospital, Fudan University

    Shanghai, Shanghai Municipality, 200011

    Xiaojun Chen, PhD, 862133189900 ext. 6429, cxjlhjj@163.com

    Bingyi Yang, MD, 862133189900 ext. 6429, xiaomihaoku@163.com

    Recruiting

  • Tenth People's Hospital of Tongji University

    Shanghai, Shanghai Municipality

    Weina Wang, 8602166300588, wangweinals@163.com

    Recruiting

Other trials in China

About this study

Official title: 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.

Read the detailed description

There were more and more women with early endometrioid endometrial cancer (EEC) and atypical endometrial hyperplasia (EAH) who want to preserve fertility. Approximately 70% to 80% of females who meet the criteria for conservation treatment are able to achieve CR after progestin therapy, with a median time of 6-7 months, but about 20% to 30% of patients get no response or need to take longer time to achieve remission (over one year). With long duration of treatment, there will be more side effects such as weight gain, impaired liver function, endometrial injury, ovarian reserve inhibition etc. which will decrease the efficacy of conservative treatment. Previous researches had shown that GnRHa plus letrozole or ethinylestradiol cyproterone plus metformin could be a better second-line treatment for progestin-insensitive patients. Till now, no similar studies were found, so we design this study to explore the efficacy of GnRHa plus letrozole and ethinylestradiol cyproterone plus metformin in progestin-insensitive EEC and EAH patients to provide new evidences for improving conservative treatment efficacy. Considered there will be more thrombotic risks in obese patients using ethinylestradiol cyproterone, we enrolled patients with BMI < 30kg/m2 only in this study.

This will be a single-centred prospective pilot study. Patients diagnosed as progestin-insensitive EAH or EEC by dilatation and curettage (D\&C) or hysteroscopy will be enrolled. Non-obese patients will be stratified by pathological diagnosis (EEC or EAH) and then they will be randomly assigned (1:1) to two arms. One will be GnRHa + letrozole group and another will be ethinylestradiol cyproterone + metformin group.

The primary endpoint is cumulative complete response (CR) rate at 28 weeks of treatment. The secondary endpoints include adverse events, duration of complete response, recurrent rate, pregnancy rate and quality of life of patients.

Being tested
GnRHa, Letrozole 2.5mg, Diane-35, MET
Medical subject headings
Endometrial Neoplasms, Endometrial Hyperplasia, Progesterone Resistance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GnRHaDrug

    Also called Triprorelin acetate

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

  • Letrozole 2.5mgDrug

    2.5mg po qd and no more than 24 weeks

  • Diane-35Drug

    Also called ethinylestradiol cyproterone

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

  • METDrug

    500mg po tid

Study groups in NCT05316935
Study groupRoleWhat they receive
Non-obese EEC group (G)Experimental20 non-obese EEC patients will be randomized to GnRHa + Letrozole group.Then every 12 weeks, an hysteroscope will be used to evaluate the endometrial condition, and the pathological findings will be recorded.
Receives: Drug: GnRHa; Drug: Letrozole 2.5mg
Non-obese EEC group (D)Experimental20 non-obese EEC patients will be randomized to Diane-35 + metformin group.Then every 12 weeks, an hysteroscope will be used to evaluate the endometrial condition, and the pathological findings will be recorded.
Receives: Drug: Diane-35; Drug: MET
Non-obese EAH group (G)Experimental20 non-obese EAH patients will be randomized to GnRHa + Letrozole group.Then every 12 weeks, an hysteroscope will be used to evaluate the endometrial condition, and the pathological findings will be recorded.
Receives: Drug: GnRHa; Drug: Letrozole 2.5mg
Non-obese EAH group (D)Experimental20 non-obese EAH patients will be randomized to Diane-35 + metformin group.Then every 12 weeks, an hysteroscope will be used to evaluate the endometrial condition, and the pathological findings will be recorded.
Receives: Drug: Diane-35; Drug: MET

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Complete response rates within 28 weeks of treatment

    The cumulative 28-week CR rates will be calculated in two groups. Patients will be evaluated with an hysteroscopy every 12 weeks. For some may delay the evaluation as personal reasons, we define the primary outcome measure as complete response rates within 28 weeks of treatment.

    Measured: From date of randomization until the date of CR, assessed up to 28 weeks

Secondary outcomes (5)

  1. Adverse events

    Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 will be recorded, as well as incidence of adverse events.

    Measured: From date of randomization until the date of CR or date of hysterectomy, assessed up to 28 weeks

  2. Time to achieve complete response

    The median CR time will be calculated in two groups

    Measured: From date of randomization until the date of CR or date of hysterectomy, assessed up to 28 weeks.

  3. Relapse rates

    Measured: Up to 2 years after the treatment

  4. Rates of fertility outcomes

    Including pregnancy and live-birth rates

    Measured: Up to 2 years after the treatment

  5. Compliance

    Measured: Data on treatment and hysteroscopy management will be collected, and deviations from study protocol will be recorded in writing. For example, the time of drug interruptions due to related toxicities or AEs, and delay of hysteroscopy for personal reasons.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Apr 2022
  2. Study start13 Jul 2022
  3. Primary completion30 Mar 2028 (estimated)
  4. Study completion30 Mar 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05316935
Sponsor's protocol ID
53211030
Status last verified
Sep 2026
First submitted
29 Mar 2022
Last updated
10 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Zhou S, Xu Z, Yang B, Guan J, Shan W, Shi Y, Chen X. Characteristics of progestin-insensitive early stage endometrial cancer and atypical hyperplasia patients receiving second-line fertility-sparing treatment. J Gynecol Oncol. 2021 Jul;32(4):e57. doi: 10.3802/jgo.2021.32.e57.

    PubMed 34085795

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing GnRHa, Letrozole 2.5mg and Diane-35 in people with Endometrial Neoplasms and Atypical Endometrial Hyperplasia, run by Xiaojun Chen at 2 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Xiaojun Chen, PhD (8602133189900 ext. 6429, cxjlhjj@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Complete response rates within 28 weeks of treatment (time frame: From date of randomization until the date of CR, assessed up to 28 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05316935, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.

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