Набор скоро начнётся NCT04976478

Study of Nimotuzumab Combined With IMRT in Elder Patients With Cervical Squamous Cell Carcinoma

— Наблюдательное Cervical Squamous Cell Carcinoma

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Nimotuzumab, EBRT combined with brachytherapy.
Кому может быть актуально: Состояния в реестре: Cervical Squamous Cell Carcinoma. Базовые параметры: от 65 лет · Женщины.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Китай
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

A Perspective, Multi-center, Single Arm Study of Nimotuzumab Combined With IMRT in Elder Patients With Cervical Squamous Cell Carcinoma

Обзор

To evaluate the efficacy and safety of Nimotuzumab combined with IMRT in elder patients with locally advanced cervical squamous cell carcinoma

Подробное описание

This is a perspective, multi-center, open-label and single arm study.

Вмешательства

Препарат Nimotuzumab
Patients receive Nimotuzumab: 200mg, intravenous infusion, weekly for 6 weeks.
Лучевая терапия EBRT combined with brachytherapy
IMRT/VMAT are adopted. A total dose of 45-50.4 Gy, 1.8\~2.0Gy/f, 25\~ 28F in pelvic and/or extension filed. For patients with metastasis in pelvic lymph node and abdominal para-aortic lymph node, the dose of radiation in local lesion will be increased to 60\~66Gy. For patients at stage IIIB, concurrent radiation will be given in parametrial extension or in the late course the dose will be increased to 60Gy. Brachytherapy: Three dimensional high dose rate brachytherapy is used with HR-CTV D90 cu

Первичные конечные точки

3-year disease-free survival(DFS) [Срок оценки: up to 3 years]

Вторичные конечные точки (7)

Complete response rate(CRR) [Срок оценки: 3 months later after treatment]
Objective response rate(ORR) [Срок оценки: 3 months later treatment]
3-year overall survival(OS) [Срок оценки: up to 3 years]
The change of tumor related markers [Срок оценки: up to 3 years]
The change of cervical tumor [Срок оценки: At diagnosis and before brachytherapy]
QUALITY OF LIFE(QoL) [Срок оценки: up to 3 years]
SAFETY [Срок оценки: up to 3 years]

Критерии участия

Критерии включения

Age≥65 years old
Histologically confirmed primary cervical squamous cell carcinoma in stage IB3-IVA (FIGO 2018)
At least one measurable lesion according to RECIST 1.1 guideline
Patients are intolerant to or refuse chemotherapy.
No serious hematopoietic dysfunction, nor abnormal heart, lung, liver and kidney function, nor immunity deficiency. And the results of lab test meet the following criteria:

Hemoglobin ≥90g/L Absolute count of neutrophils≥2×109/L orwhite blood cell count≥4.0×109/L； Platelet count≥100×109/L； AST≤2.5×ULN ALT≤2.5×ULN TBIL≤1.5×ULN；

Serum creatinine≤1.5×ULN or CrCl> 60 mL/min(according toCockcroft-Gault):

Serum creatinine≤1.5×ULN Female CrCl=(140-Age)×Weight（kg）×0.85 / (72×Scr mg/dl)

ECOG score 0-2
Expectancy of life is at least 3 months.
Eligible for pelvic MRI examination.
The patients voluntarily received nimotuzumab combined with radiotherapy.
Patients can comply with the protocol and are willing to sign informed consent.

Критерии исключения

Patients who have received treatment for cervical cancer, including surgery, radiotherapy, chemotherapy, targeted therapy and immunotherapy
Patients who have bilateral ureteral obstruction, who cannot be placed ureteral stents or perform pyelostomy.
Patients with rectovaginal fistula/vaginovesical fistula/uncontrolled vaginal bleeding or with fistula risk.

.4)Patients infected with HIV. 5)Active hepatitis B (HBV DNA quantitative test results exceed the detection threshold), or HCV infection (HCV RNA quantitative test results exceed the detection threshold) 6)Patients with severe underlying disease that makes it possible to safely receive the treatment. And the severe underlying disease include but not limited to active infections requiring systemic medication, decompensated heart failure (NYHA grade III and IV), unstable angina pectoris, and acute myocardial infarction occurred within the first 3 months of enrollment.

7)Patients with a history of prior malignancy other than cured basal cell carcinoma of the skin.

8)Patients with Crohn's disease and ulcerative colitis. 9)Patients are allergic to Nimotuzumab or its compounds. 10)Patients with neurological or psychiatric abnormalities that affect cognitive ability.

11)Intracavitary brachytherapy cannot be performed that was assessed by the investigator.

12)Other factors were assessed by investigators to be unsuitable to this study.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет