2025-523877-40-00招募中2 期
TREAT-EC (Tirzepatide in the treatment of endometrial cancer) - a clinical trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 78
- 试验地点
- 2
- 主要终点
- The proportion (%) of patients with a pCR in each group 12 months (52 weeks ±14 days) post randomisation. pCR will be defined as the absence of any EAC or endometrial hyperplasia on endometrial biopsy using a H&E slide assessed by an independent pathologist after 12 months (Visit 14, 52 weeks ±14 days) of treatment.
研究概览
简要总结
The proportion (%) of patients with a pCR in each group 12 months (Visit 14, 52 weeks ±14 days) post randomization.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed FIGO grade 1 or 2 endometrioid adenocarcinoma on a curette or endometrial biopsy, p53 WT, MMR proficient.
- •Serum CA125 ≤30 U/mL.
- •No known hypersensitivity or contraindications for LNG-IUS (severe liver disease, personal history of breast cancer, active pelvic inflammatory disease, congenital uterine abnormality) or GLP-1 agonist
- •Ability to comply with endometrial biopsies at specified 3 monthly intervals
- •Inclusion of patients, who in the opinion of the gynaecological multidisciplinary team, at screening, are not suitable candidates for radiotherapy.
- •Negative serum pregnancy test in pre-menopausal women and women < 2 years after the onset of menopause
- •No LNG-IUS or LNG-IUS inserted < 6 weeks prior to enrolment
- •Subjects must be able and willing to give written informed consent and to comply with the requirements of this study protocol
- •Females with a BMI > 27 kg/m2 at high risk of surgical complications due to co-morbidities (diabetes, hypertension, cardiovascular disease, obstructive sleep apnoea) or BMI > 30 kg/m2 with no comorbidities and who are at risk of surgical complications or have decided not to opt for immediate surgical intervention (having been advised that this is the standard of care).
- •Over 18 years of age at time of randomisation
- •CT scan of pelvis, abdomen and chest (or chest X-Ray) suggesting the absence of extrauterine disease in patients with endometrial cancer only
- •Myometrial invasion on MRI of not more than 50%
- •No lymph vascular invasion on biopsy.
排除标准
- •ECOG performance status ≥3
- •Obesity induced by other endocrine disorders (e.g., Cushing syndrome)
- •Current or history of treatment with medications that may cause significant weight gain within 3 months prior to screening visit, including systemic corticosteroids (except for a short course of treatment, i.e., 7-10 days), promtri-cyclic antidepressants, atypical antipsychotic and mood stabilisers (e.g., imipramine, amitriptyline, mirtazapine, phenelzine, chlorpromazine, thioridazine, clozapine, olanzapine, valproic acid and its derivatives, and lithium)
- •Grade 1 or 2 endometrioid adenocarcinoma of the endometrium with myometrial invasion deeper than 50% on MRI or any patients with grade 3 endometrioid adenocarcinoma
- •Participation in a clinical trial of weight control within the last 3 months prior to screening for this trial
- •Previous surgical treatment for obesity (excluding liposuction if performed >1 year before study entry)
- •History of major depressive disorder or a PHQ-9 >15 within the last 2 years (completed at visit 1) or history of other severe psychiatric disorders (e.g., schizophrenia or bipolar disorder) or diagnosis of an eating disorder such as restrained eating, binge eating, or bulimia (based on Questionnaire for Diagnosing Binge Eating Disorder and Bulimia Nervosa completed at visit 1)
- •Participants with a lifetime history of a suicide attempt or history of any suicidal behaviour within the past month before entry into the trial
- •Surgery scheduled for the trial duration period, except for minor surgical procedures, at the discretion of the Investigator
- •Impaired liver function, defined as screening aspartate aminotransferase or alanine aminotransferase ≥ 2.5 times upper normal range (one re-test analyzed at the local laboratory within 1 week prior to screening is permitted with the last sample being conclusive)
- •Impaired renal function defined as eGFR <90mL/min/1.73L2 (1 retest within 1 week prior to screening through the local laboratory is permitted with the result of the last sample conclusive)
- •Evidence of extra-uterine extension on cross sectional imaging
- •Known clinically significant active cardiovascular disease, including history of unstable angina, acute coronary event, other significant cardiac events (including history of arrhythmias, myocardial infarction (MI), or conduction delays on electrocardiogram [ECG]), or cerebral stroke within the past 6 months and/or heart failure (New York Heart Association [NYHA] Class III or IV) at the discretion of the Investigator
- •Uncontrolled treated/untreated hypertension (systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥80 mmHg). If white-coat hypertension is suspected at the screening visit a repeated measurement at run-in prior to other trial-related activities is allowed
- •Known or suspected abuse of alcohol or narcotics
- •MMR deficient or p53 mutated endometrial cancer.
- •Language barrier, mental incapacity, unwillingness or ability to understand and being able to complete the mental health questionnaire in the provided language
- •History of breast, thyroid or colon cancer
- •Current other cancer (past or present, except basal cell skin cancer or squamous cell skin cancer)
- •Breastfeeding mothers
- •Histological (cell) type other than endometrioid adenocarcinoma (sarcomas or high risk endometrial e.g. papillary serous, clear cell)
- •Pregnant or planning to become pregnant during trial period
- •Congenital or acquired uterine anomaly which distorts the uterine cavity
- •Prior treatment for EAC
- •Patients with a history of pelvic or abdominal radiotherapy
- •Unwilling to have additional endometrial biopsies or unable to attend monthly clinical assessments
- •Unable to provide informed consent or complete questionnaires
- •Participants with a history of severe gastrointestinal disease, gastroparesis or significant dysmotility, or prior aspiration with anaesthesia
- •Acute pelvic inflammatory disease and/or untreated sexually transmitted diseases and genital infections
- •Genital actinomycosis
- •History of pancreatitis
- •Diagnosis of Type 1 diabetes
- •Previous treatment with GLP-1 receptor agonists within the last 3 months
- •Visit 1 thyroid-stimulatory hormone (TSH) outside of the range of 0.4-6.0 mIUl-1
研究组 & 干预措施
Mirena 52 mg Intrauterine delivery system
Test
干预措施: Mirena 52 mg Intrauterine delivery system (Drug)
Mounjaro 7.5 mg/dose KwikPen solution for injection in pre-filled pen, Mounjaro 10 mg/dose KwikPen solution for injection in pre-filled pen, Mounjaro 2.5 mg/dose KwikPen solution for injection in pre-filled pen, Mounjaro 12.5 mg/dose KwikPen solution for injection in pre-filled pen, Mounjaro 15 mg/dose KwikPen solution for injection in pre-filled pen, Mounjaro 5 mg/dose KwikPen solution for injection in pre-filled pen
Test
干预措施: Mounjaro 7.5 mg/dose KwikPen solution for injection in pre-filled pen (Drug)
Mounjaro 7.5 mg/dose KwikPen solution for injection in pre-filled pen, Mounjaro 10 mg/dose KwikPen solution for injection in pre-filled pen, Mounjaro 2.5 mg/dose KwikPen solution for injection in pre-filled pen, Mounjaro 12.5 mg/dose KwikPen solution for injection in pre-filled pen, Mounjaro 15 mg/dose KwikPen solution for injection in pre-filled pen, Mounjaro 5 mg/dose KwikPen solution for injection in pre-filled pen
Test
干预措施: Mounjaro 10 mg/dose KwikPen solution for injection in pre-filled pen (Drug)
Mounjaro 7.5 mg/dose KwikPen solution for injection in pre-filled pen, Mounjaro 10 mg/dose KwikPen solution for injection in pre-filled pen, Mounjaro 2.5 mg/dose KwikPen solution for injection in pre-filled pen, Mounjaro 12.5 mg/dose KwikPen solution for injection in pre-filled pen, Mounjaro 15 mg/dose KwikPen solution for injection in pre-filled pen, Mounjaro 5 mg/dose KwikPen solution for injection in pre-filled pen
Test
干预措施: Mounjaro 2.5 mg/dose KwikPen solution for injection in pre-filled pen (Drug)
Mounjaro 7.5 mg/dose KwikPen solution for injection in pre-filled pen, Mounjaro 10 mg/dose KwikPen solution for injection in pre-filled pen, Mounjaro 2.5 mg/dose KwikPen solution for injection in pre-filled pen, Mounjaro 12.5 mg/dose KwikPen solution for injection in pre-filled pen, Mounjaro 15 mg/dose KwikPen solution for injection in pre-filled pen, Mounjaro 5 mg/dose KwikPen solution for injection in pre-filled pen
Test
干预措施: Mounjaro 12.5 mg/dose KwikPen solution for injection in pre-filled pen (Drug)
Mounjaro 7.5 mg/dose KwikPen solution for injection in pre-filled pen, Mounjaro 10 mg/dose KwikPen solution for injection in pre-filled pen, Mounjaro 2.5 mg/dose KwikPen solution for injection in pre-filled pen, Mounjaro 12.5 mg/dose KwikPen solution for injection in pre-filled pen, Mounjaro 15 mg/dose KwikPen solution for injection in pre-filled pen, Mounjaro 5 mg/dose KwikPen solution for injection in pre-filled pen
Test
干预措施: Mounjaro 15 mg/dose KwikPen solution for injection in pre-filled pen (Drug)
Mounjaro 7.5 mg/dose KwikPen solution for injection in pre-filled pen, Mounjaro 10 mg/dose KwikPen solution for injection in pre-filled pen, Mounjaro 2.5 mg/dose KwikPen solution for injection in pre-filled pen, Mounjaro 12.5 mg/dose KwikPen solution for injection in pre-filled pen, Mounjaro 15 mg/dose KwikPen solution for injection in pre-filled pen, Mounjaro 5 mg/dose KwikPen solution for injection in pre-filled pen
Test
干预措施: Mounjaro 5 mg/dose KwikPen solution for injection in pre-filled pen (Drug)
结局指标
主要结局
The proportion (%) of patients with a pCR in each group 12 months (52 weeks ±14 days) post randomisation. pCR will be defined as the absence of any EAC or endometrial hyperplasia on endometrial biopsy using a H&E slide assessed by an independent pathologist after 12 months (Visit 14, 52 weeks ±14 days) of treatment.
The proportion (%) of patients with a pCR in each group 12 months (52 weeks ±14 days) post randomisation. pCR will be defined as the absence of any EAC or endometrial hyperplasia on endometrial biopsy using a H&E slide assessed by an independent pathologist after 12 months (Visit 14, 52 weeks ±14 days) of treatment.
次要结局
- The mean percentage fasting weight loss at 12 months (Visit 14, 52 weeks ±14 days) post randomization.
- The change in Ki-67 PI 12 months (Visit 14, 52 weeks ±14 days) post randomization.
- Quality of life assessment at baseline (day -30 to 0), 3 (Visit 4, Week 12, 6 (Visit 7, Week 24), and 12 months (Visit 14, 52 weeks ±14 days).
- Safety - The proportion of patients who develop progressive disease during the trial at 6 and 12 months. Progression is defined in section 3.4.
- Progression to surgery - The proportion of patients who progress to surgical management of endometrial cancer ie. hysterectomy following weight loss
研究者
prof. Donal Brennan
Scientific
University College Dublin
研究点 (2)
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