Clinical trial NCT06942377: Calcium Channel Blocker Amlodipine for Endometrial Cancer Therapy
Official title: Peking University People's Hospital
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Endometrial Cancer
Atypical Endometrial Hyperplasia
Keywords: endometrial cancer
atypical hyperplasia
calcium channel blocker
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
First posted: 2025-04-24
Enrollment: 140
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 (no preset position, no specific object).
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Pathological cumulative complete response rate
timeFrame: 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
measure: Time to Complete remission
timeFrame: 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
Secondary outcomes:
measure: Recurrence rate
timeFrame: 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
measure: Pregnancy rate
timeFrame: 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
measure: Live birth rate
timeFrame: Day 1:take medication orally every day；Every three months, undergo hysteroscopy to obtain endometrium for HE and IHC of ER/PR; Observe the pregnancy and delivery rates within 3 years of complete remission of patients
measure: Pathological biomarker
timeFrame: 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
measure: Adverse reactions
timeFrame: 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
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University People's Hospital
state: Beijing
Study officials:
References: