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NCT Number: NCT06942377

Calcium Channel Blocker Amlodipine for Endometrial Cancer Therapy

To explore the treatment efficacy of Progesterone Therapeutic Regimen Plus Amlodipine in patients with early endometrial carcinoma (EEC) for conservative treatment.

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

About this study

After diagnosed of EEC by hysteroscopy, patients meet the study criteria will be enrolled. The age, height, weight, waistline, blood pressure, drug load, basic history of infertility and family cancer will be collected. Blood tests, including calcium, albumin, fasting blood glucose (FBG), fasting insulin (FINS), blood lipids, sex hormone levels, anti-müllerian hormone (AMH) and renal/liver function tests will be performed before treatment to evacuate their basic conditions.

Patients with endometrial cancer who met the inclusion criteria were randomly divided into the control group and the experimental group in a 1:1 ratio according to the random numbers generated in advance. The administration regimen for the two groups was as follows:

Control group: progesterone regimen (oral medroxyprogesterone acetate tablet 250mg-500mg/ day or Mirena +GnRHa 3.75mg subcutaneous injection monthly); Trial group: progesterone regimen (oral medroxyprogesterone acetate tablet 250mg-500mg/ day or Mirena +GnRHa3.75mg subcutaneous injection monthly) combined with Amlodipine (oral Amlodipine 5mg/ day); The specific selection of progesterone regimen was based on whether the patients had oral progesterone contraindications and if BMI≥28kg/m2 was not suitable for oral progesterone, Mirena +GnRHa regimen was selected. The choice of Amlodipine is based on the results that Amlodipine can inhibite growth in several endometrial cancer cells, PDX model and patient-derived cells.

For patients remained SD after 9 months of treatment but refused hysterectomy, a multiple disciplinary discussion would be held for individual case, and alternative treatment would be given. Maintenance treatment will be recommended for patients with CR, and participants will be followed up for at least 1 year.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Pathological diagnosis of endometrial adenocarcinoma G1-2 of the endometrium
  • If the pathology is endometrial cancer, MRI or ultrasound confirms that the lesion is limited to the endometrium or invading the muscle<1/2, that is, FIGO (2009) stage IA
  • Age ≤ 45 years old
  • Require those who wish to retain their reproductive function to sign informed consent
  • No serious internal medicine complications (severe liver and kidney dysfunction)
  • No contraindications for progesterone treatment or pregnancy
  • Has not experienced hypotension more than three times in the past six months and can be regularly monitored for blood pressure
  • Imaging shows no evidence of distant metastasis
  • A. Initial treatment patients: have not used any protective treatment drugs (progestogens, GNRH-a); B. One course of treatment (12 weeks) with incomplete remission of the lesion (partial remission, persistent or progressive lesion); C. Two courses of treatment (24 weeks) with incomplete remission (partial remission, persistent or progressive lesions);

Exclusion criteria

  • Tumor invasion of muscle layer>1/2, FIGO (2009) stage IB or above
  • Tumor differentiation into G3 or non endometrioid adenocarcinoma
  • Merge malignant tumors from other parts
  • Individuals with contraindications to conservative treatment or medication use
  • Patients known to have experienced hypotension
  • Patients who have taken other types of antihypertensive drugs regularly in the past

Treatment and study plan

Amlodipine

Drug

Progesterone regimen (oral medroxyprogesterone acetate tablet 250mg-500mg/ day or Mirena +GnRHa3.75mg subcutaneous injection monthly) combined with Amlodipine

Primary outcomes

  1. Pathological cumulative complete response rate after 6 months treatment

    Time frame: Day 1:take medication orally every day;Every three months, undergo hysteroscopy to obtain endometrium for HE and IHC of ER/PR; assessed up to 6-7 months

    No endometrioid carcinoma or any proliferative lesion is found by pathology; imaging examination shows no evidence of a tumor

Secondary outcomes

  1. Recurrence rate

    Time frame: Day 1:take medication orally every day;Every three months, undergo hysteroscopy to obtain endometrium for HE and IHC of ER/PR; up to 12 months after the end of treatment.

    After complete remission, there is evidence of recurrence in pathology, and the imaging examination shows that the lesion recurrences.

  2. Pathological cumulative complete response rate after 12 months treatment

    Time frame: assessed up to 12 months

    The ratio of woman achieved CR after 12 months treatment

  3. Pregnancy rate

    Time frame: Day 1:take medication orally every day;Every three months, undergo hysteroscopy to obtain endometrium for HE and IHC of ER/PR; Through study completion, an average of 1 year

    A pregnancy test shows pregnancy after CR.

  4. Pathological biomarker

    Time frame: Day 1:take medication orally every day;Every three months, undergo hysteroscopy to obtain endometrium for HE and IHC of ER/PR; Through study completion, an average of 1 year

    pathological markers(such as Ki-67, estrogen receptor, progesterone receptor, p53, PTEN, MLH1, PMS2, MSH2, and MSH6) at each hysteroscopy

  5. Adverse reactions

    Time frame: Day 1:take medication orally every day;Every three months, serological testing confirms the effects of drugs on the liver and kidneys; Through study completion, an average of 1 year

    Any unfavorable response resulting from the administration of any pharmaceutical agent utilized as part of the therapeutic regimen.

Study contacts

Contact information is provided by the study sponsor or research team.

Huang Dr. Huang Ting, ph.d

CONTACT

[email protected]

010-88324474 ext. 18817819137

Wang JL Prof. Wang Jianliu, Ph.d

CONTACT

[email protected]

0086-010-88324381

Sponsors and collaborators

Lead sponsor

Peking University People's Hospital

Other

Registry information

Official study title

Peking University People's Hospital

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Apr 24, 2025
Registry last updated
Jul 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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