Calcium Channel Blocker Amlodipine for Endometrial Cancer Therapy

Peking University People's Hospital

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

Study Overview

• Status: Not yet recruiting
• Conditions: Endometrial Cancer
• Intervention / Treatment: Drug: Amlodipine

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 140
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Wang JL Prof. Wang Jianliu, Ph.d; Phone Number: 0086-010-88324381; Email: wangjianliu1203@163.com
• Study Contact Backup: Name: Huang Dr. Huang Ting, ph.d; Phone Number: 18817819137 010-88324474; Email: 18817819137@163.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100044
      • Peking University People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Pathological diagnosis of endometrial adenocarcinoma G1-2 of the endometrium
2. 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
3. Age ≤ 45 years old
4. Require those who wish to retain their reproductive function to sign informed consent
5. No serious internal medicine complications (severe liver and kidney dysfunction)
6. No contraindications for progesterone treatment or pregnancy
7. Has not experienced hypotension more than three times in the past six months and can be regularly monitored for blood pressure
8. Imaging shows no evidence of distant metastasis
9. 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:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Participant Group; Progesterone regimen (oral medroxyprogesterone acetate tablet 250mg-500mg/ day or mirena +GnRHa 3.75mg subcutaneous injection monthly)
Experimental: Amlodipine Intervention; Progesterone regimen (oral medroxyprogesterone acetate tablet 250mg-500mg/ day or Mirena +GnRHa3.75mg subcutaneous injection monthly) combined with Amlodipine 5mg/day. If the patient's blood pressure is higher than 140/90mmHg at 5mg/d, the dose of amlodipine can be increased to 10mg/day	Drug: Amlodipine; Progesterone regimen (oral medroxyprogesterone acetate tablet 250mg-500mg/ day or Mirena +GnRHa3.75mg subcutaneous injection monthly) combined with Amlodipine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pathological cumulative complete response rate after 6 months treatment	No endometrioid carcinoma or any proliferative lesion is found by pathology; imaging examination shows no evidence of a tumor	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pregnancy rate	A pregnancy test shows pregnancy after CR.	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 biomarker	pathological markers(such as Ki-67, estrogen receptor, progesterone receptor, p53, PTEN, MLH1, PMS2, MSH2, and MSH6) at each hysteroscopy	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
Adverse reactions	Any unfavorable response resulting from the administration of any pharmaceutical agent utilized as part of the therapeutic regimen.	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
Recurrence rate	After complete remission, there is evidence of recurrence in pathology, and the imaging examination shows that the lesion recurrences.	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.
Pathological cumulative complete response rate after 12 months treatment	The ratio of woman achieved CR after 12 months treatment	assessed up to 12 months

Collaborators and Investigators

• Sponsor: Peking University People's Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): July 15, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: March 10, 2025
• First Submitted That Met QC Criteria: April 16, 2025
• First Posted (Actual): April 24, 2025

Study Record Updates

• Last Update Posted (Estimated): July 8, 2025
• Last Update Submitted That Met QC Criteria: July 2, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: endometrial cancer; calcium channel blocker
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Uterine Diseases; Genital Diseases, Female; Genital Neoplasms, Female; Uterine Neoplasms; Endometrial Neoplasms; Calcium-Regulating Hormones and Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Membrane Transport Modulators; Calcium Channel Blockers; Vasodilator Agents; Antihypertensive Agents; Amlodipine
• Other Study ID Numbers: Peking University (Peking University)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No