Calcium Channel Blocker Amlodipine for Endometrial Cancer Therapy
- Registration Number
- NCT06942377
- Lead Sponsor
- Peking University People's Hospital
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- Female
- Target Recruitment
- 140
- Pathological diagnosis of endometrial adenocarcinoma G1-2 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
- Has not experienced hypotension more than three times in the past six months and can be regularly monitored for blood pressure
- Imaging shows no evidence of distant metastasis
- 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);
- 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. If the patient's blood pressure is higher than 140/90mmHg at 5mg/d, the dose of amlodipine can be increased to 10mg/day
- Primary Outcome Measures
Name Time Method Pathological cumulative complete response rate after 6 months treatment 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 No endometrioid carcinoma or any proliferative lesion is found by pathology; imaging examination shows no evidence of a tumor
- 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; up to 12 months after the end of treatment. After complete remission, there is evidence of recurrence in pathology, and the imaging examination shows that the lesion recurrences.
Pathological cumulative complete response rate after 12 months treatment assessed up to 12 months The ratio of woman achieved CR after 12 months treatment
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.
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
Peking University People's Hospital🇨🇳Beijing, Beijing, China