To explore the treatment efficacy of Progesterone Therapeutic Regimen Plus Amlodipine in patients with early endometrial carcinoma (EEC) for conservative treatment.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
140
Progesterone regimen (oral medroxyprogesterone acetate tablet 250mg-500mg/ day or Mirena +GnRHa3.75mg subcutaneous injection monthly) combined with Amlodipine
Peking University People's Hospital
Beijing, Beijing Municipality, China
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
Time frame: 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
Recurrence rate
After complete remission, there is evidence of recurrence in pathology, and the imaging examination shows that the lesion recurrences.
Time frame: 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
Time frame: assessed up to 12 months
Pregnancy rate
A pregnancy test shows pregnancy after CR.
Time frame: 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
Time frame: 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.
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Time frame: 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