Calcium Channel Blocker Amlodipine for Endometrial Cancer Therapy

Peking University

Status and phase: Not yet enrolling; Phase 2

Conditions: Endometrial Cancer; Atypical Endometrial Hyperplasia

Treatments: Drug: Amlodipine

Study type: Interventional

Funder types: Other

Identifiers

NCT06942377

Peking University

Details and patient eligibility

About

To explore the treatment efficacy of Progesterone Therapeutic Regimen Plus Azelnidipine in patients with atypical endometrial hyperplasia (AEH) and early endometrial carcinoma (EEC) for conservative treatment.

Full description

After diagnosed of AEH or 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 Azelnidipine (oral Azelnidipine 8mg/ 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 Azelnidipine is based on the results that Azelnidipine 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.

Enrollment: 140 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Pathological diagnosis of endometrial adenocarcinoma G1-2 or atypical hyperplasia 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. Have not experienced hypotension in the past six months and can regularly monitor my blood pressure
8. Imaging shows no evidence of distant metastasis

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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140 participants in 2 patient groups

Participant Group

No Intervention group

Description:

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

Amlodipine Intervention

Experimental group

Description:

Progesterone regimen (oral medroxyprogesterone acetate tablet 250mg-500mg/ day or Mirena +GnRHa3.75mg subcutaneous injection monthly) combined with Amlodipine 5mg/day

Treatment:

Drug: Amlodipine