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Набор скоро начнётся NCT07266350

A Non-interventional Registration Study of Monotherapy or Combination Regimens Based on Camrelizumab or Famitinib for the Treatment of Cervical Cancer

— Наблюдательное Cervical Cancer Metastatic Cervical Cancer Recurrent

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: Camrelizumab, Famitinib.
Кому может быть актуально
Состояния в реестре: Cervical Cancer Metastatic, Cervical Cancer Recurrent. Базовые параметры: от 18 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
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

This trial is a national multicenter, open-label, non-interventional study to observe and evaluate the safety and efficacy of monotherapy or combination regimens based on camrelizumab or famitinib in patients with cervical cancer. This study included patients with cervical cancer who used monotherapy or combination regimens based on camrelizumab or famitinib. The administration regimens include but are not limited to camrelizumab monotherapy, camrelizumab in combination with mitinib, famitinib monotherapy, camrelizumab in combination with other treatment regimens selected by the investigator, camrelizumab in combination with mitinib and other treatment regimens selected by the investigator, and famitinib in combination with other treatment regimens selected by the investigator. It is planned to include cervical cancer patients who have decided to be treated with monotherapy or combination regimens based on camrelizumab or famitinib before enrollment, with an estimated 1,300 cases. According to the treatment plan received by the patients, after enrollment, they can be respectively placed in one of the following six cohorts: Queue 1: Only receiving camrelizumab monotherapy Queue 2: Only receiving famitinib monotherapy Queue 3: Only combination therapy of camrelizumab and famitinib was received Queue 4: Receiving camrelizumab in combination with other treatment regimens Queue 5: Receiving famitinib in combination with other treatment regimens Queue 6: Receiving camrelizumab and famitinib in combination with other treatment regimens Data from the baseline period, treatment period and follow-up period were collected respectively according to the cohort category (prospective or retrospective) of the enrolled patients.

Вмешательства

  • Препарат Camrelizumab
    200mg IV Q3W
  • Препарат Famitinib
    20mg QD PO

Первичные конечные точки

  • safety according to CTCAE v5.0 [Срок оценки: From the first administration to 30 days after the end of the medication]
Вторичные конечные точки (2)
  • real world ORR [Срок оценки: from the initiation of monotherapy or combination regimens, per 6-8 weeks]
  • overall survival [Срок оценки: From date of treatment until the date of date of death from any cause, assessed up to 3 years]

Критерии участия

Критерии включения

  • Age ≥18 years old;
  • Sign the informed consent form and voluntarily join this study;
  • Patients with cervical cancer diagnosed by histopathology;
  • Receive treatment with monotherapy or combination regimens based on camrelizumab or famitinib;
  • It is necessary to agree to take effective contraceptive measures and avoid egg donation from the time of signing the informed consent form until 2 months after the last administration of camrelizumab, 3 months after the last administration of famitinib, or within the contraceptive period specified in the instructions of the last administration of other study drugs (whichever is longer).

If a patient has had menstruation but has not yet reached postmenopausal status (with no menstruation for a continuous period of ≥12 months and no other causes found except menopause), and has not undergone sterilization surgery (such as hysterectomy, bilateral tubal ligation or bilateral oophorectomy), the patient is considered to have fertility.

Критерии исключения

  • There is already evidence indicating that the patient is a pregnant or lactating woman.
  • Currently participating in any research involving intervention measures outside of regular clinical practice;
  • The researcher determines other circumstances that are not suitable for inclusion in the study.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Другое

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07266350 · CZLL2025-042-001

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗