Status:
NOT_YET_RECRUITING
Calcium Channel Blocker Amlodipine for Endometrial Cancer Therapy
Lead Sponsor:
Peking University People's Hospital
Conditions:
Endometrial Cancer
Eligibility:
FEMALE
18-45 years
Phase:
PHASE2
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...
Eligibility Criteria
Inclusion
- 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);
Exclusion
- 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
Key Trial Info
Start Date :
July 15 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT06942377
Start Date
July 15 2025
End Date
December 1 2027
Last Update
July 8 2025
Active Locations (1)
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1
Peking University People's Hospital
Beijing, Beijing Municipality, China, 100044