Calcium Channel Blocker Amlodipine for Endometrial Cancer Therapy

NCT06942377 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: Peking University
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

To explore the treatment efficacy of Progesterone Therapeutic Regimen Plus Amlodipine in patients with early endometrial carcinoma (EEC) for conservative treatment.

Conditions

Endometrial Cancer

Keywords

endometrial cancer; calcium channel blocker

Outcome Measures

Primary Outcomes (1)

• 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

  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

Secondary Outcomes (5)

• 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.

• Pathological cumulative complete response rate after 12 months treatment

  assessed up to 12 months

• 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

• 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

• 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

Study Arms (2)

Participant Group

NO INTERVENTION

Progesterone regimen (oral medroxyprogesterone acetate tablet 250mg-500mg/ day or mirena +GnRHa 3.75mg subcutaneous injection monthly)

Amlodipine Intervention

EXPERIMENTAL

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

Drug: Amlodipine

Interventions

Amlodipine DRUG

Progesterone regimen (oral medroxyprogesterone acetate tablet 250mg-500mg/ day or Mirena +GnRHa3.75mg subcutaneous injection monthly) combined with Amlodipine

Amlodipine Intervention

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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);

You may not qualify if:

• 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

Sponsors & Collaborators

• Peking University People's Hospital: lead

Study Sites (1)

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

Location

MeSH Terms

Conditions

Endometrial Neoplasms

Interventions

Amlodipine

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Wang JL Prof. Wang Jianliu, Ph.d

CONTACT

0086-010-88324381; wangjianliu1203@163.com

Huang Dr. Huang Ting, ph.d

CONTACT

010-88324474; 18817819137@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Peking University People's Hospital

Model Details: 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).

Study Record Dates

• First Submitted: March 10, 2025
• First Posted: April 24, 2025
• Study Start: July 15, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: July 8, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)