Endometrial CancerPhase 2NCT06942377
Calcium Channel Blocker Amlodipine for Endometrial Cancer Therapy
A Phase 2 study testing Amlodipine in people with Endometrial Cancer, run by Peking University People's Hospital at 1 site in China.
Trial summary
To explore the treatment efficacy of Progesterone Therapeutic Regimen Plus Amlodipine in patients with early endometrial carcinoma (EEC) for conservative treatment. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Endometrial Cancer
- What is being tested?
- Amlodipine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteChina
- Study dates
- 15 Jul 2025to 1 Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
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- 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);
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Peking University People's Hospital
Beijing, Beijing Municipality, 100044
About this study
Official title: Peking University People's Hospital
To explore the treatment efficacy of Progesterone Therapeutic Regimen Plus Amlodipine in patients with early endometrial carcinoma (EEC) for conservative treatment.
Read the 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.
- Conditions
- Endometrial Cancer
- Being tested
- Amlodipine
- Keywords
- endometrial cancer, calcium channel blocker
- Medical subject headings
- Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AmlodipineDrug
Progesterone regimen (oral medroxyprogesterone acetate tablet 250mg-500mg/ day or Mirena +GnRHa3.75mg subcutaneous injection monthly) combined with Amlodipine
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Amlodipine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
After complete remission, there is evidence of recurrence in pathology, and the imaging examination shows that the lesion recurrences.
Measured: 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
Measured: assessed up to 12 months
Pregnancy rate
A pregnancy test shows pregnancy after CR.
Measured: 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
Measured: 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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2025
- Study start15 Jul 2025 (estimated)
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometrial CancerStudies of the same condition, open and under way.
- More trials run by Peking University People's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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).
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wang Jianliu, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06942377
- Sponsor's protocol ID
- Peking University
- Status last verified
- Apr 2025
- First submitted
- 10 Mar 2025
- Last updated
- 8 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peking University People's Hospital
- ClinicalTrials.gov ID
- NCT06942377
- Acronym / sponsor ID
- Peking University
- Conditions
- Endometrial Cancer
- Keywords
- endometrial cancer, calcium channel blocker
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- 15 Jul 2025 (estimated)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 24 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| Participant Group | No intervention | –Progesterone regimen (oral medroxyprogesterone acetate tablet 250mg-500mg/ day or mirena +GnRHa 3.75mg subcutaneous injection monthly) |
| Amlodipine Intervention | Experimental | Drug: AmlodipineProgesterone 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 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AmlodipineProgesterone regimen (oral medroxyprogesterone acetate tablet 250mg-500mg/ day or Mirena +GnRHa3.75mg subcutaneous injection monthly) combined with Amlodipine | Drug | Amlodipine Intervention |
Primary outcome
Pathological cumulative complete response rate after 6 months treatment
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
No endometrioid carcinoma or any proliferative lesion is found by pathology; imaging examination shows no evidence of a tumor
5 secondary outcomes
Recurrence rate
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
Time frame: assessed up to 12 months
Pregnancy rate
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
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Amlodipine in people with Endometrial Cancer, run by Peking University People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wang JL Prof. Wang Jianliu, Ph.d (0086-010-88324381, wangjianliu1203@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological cumulative complete response rate after 6 months treatment (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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2025.