Calcium Channel Blocker Amlodipine for Endometrial Cancer Therapy
- Conditions
- Endometrial CancerAtypical Endometrial Hyperplasia
- Interventions
- Registration Number
- NCT06942377
- Lead Sponsor
- Peking University People's Hospital
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- Female
- Target Recruitment
- 140
- Pathological diagnosis of endometrial adenocarcinoma G1-2 or atypical hyperplasia 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
- Have not experienced hypotension in the past six months and can regularly monitor my blood pressure
- Imaging shows no evidence of distant metastasis
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Amlodipine Intervention Amlodipine Progesterone regimen (oral medroxyprogesterone acetate tablet 250mg-500mg/ day or Mirena +GnRHa3.75mg subcutaneous injection monthly) combined with Amlodipine 5mg/day
- Primary Outcome Measures
Name Time Method Pathological cumulative complete response rate 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 No endometrioid carcinoma or any proliferative lesion is found by pathology; imaging examination shows no evidence of a tumor
Time to Complete remission 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 Time to CR was calculated from the commencement of fertility-preserving treatment to the date of the initial hysteroscopic examination to confirm CR
- Secondary Outcome Measures
Name Time Method Recurrence rate 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 After complete remission, there is evidence of recurrence in pathology, and the imaging examination shows that the lesion recurrences.
Pregnancy rate 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.
Live birth rate 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 The live birth rate is defined as the ratio of live births to pregnancies
Pathological biomarker 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
Adverse reactions 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.
Trial Locations
- Locations (1)
Peking University People's Hospital
🇨🇳Beijing, Beijing, China