Calcium Channel Blocker Amlodipine for Endometrial Cancer Therapy

NCT ID: NCT06942377

Last Updated: 2025-07-08

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-15
• Study Completion Date: 2027-12-01

Brief Summary

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

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.

Conditions

Endometrial Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Participant Group

Progesterone regimen (oral medroxyprogesterone acetate tablet 250mg-500mg/ day or mirena +GnRHa 3.75mg subcutaneous injection monthly)

Group Type: NO_INTERVENTION

No interventions assigned to this group

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

Group Type: EXPERIMENTAL

Amlodipine

Intervention Type: DRUG

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

Interventions

Amlodipine

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Peking University People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Wang Jianliu

Peking University People's Hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Peking University People's Hospital

Beijing, Beijing Municipality, China

Countries

China

Central Contacts

Wang JL Prof. Wang Jianliu, Ph.d

Role: CONTACT

wangjianliu1203@163.com

0086-010-88324381

Huang Dr. Huang Ting, ph.d

Role: CONTACT

18817819137@163.com

010-88324474 ext. 18817819137

Other Identifiers

Peking University

Identifier Type: -

Identifier Source: org_study_id