Autologous Tumor Infiltrating Lymphocytes (GT101 Injection) in Patients With Recurrent or Metastatic Cervical Cancer

Официальное название

A Phase 2, Multicenter Randomized Controlled Open-label Study of Autologous Tumor Infiltrating Lymphocytes (GT101 Injection) in Patients With Recurrent or Metastatic Cervical Cancer

Обзор

This is a Phase II, multicenter, open-label, randomized, parallel group, treatment study to assess the efficacy and safety of Autologous Tumor Infiltrating Lymphocytes (GT101 injection) compared with Gemcitabine in participants with recurrent or metastatic cervical cancer.

Вмешательства

• Биопрепарат GT101 injection
  GT101 injection to treat cervical cancer
• Препарат Gemcitabine injection
  Gemcitabine injection to treat cervical cancer

Первичные конечные точки

• Progression Free Survival [Срок оценки: 3 years]

Вторичные конечные точки (2)

• Duration of Response [Срок оценки: 3 years]
• Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 [Срок оценки: 3 years]

Критерии участия

Критерии включения

• 1\. The Patients (or legally authorized representative) Patients (or legally authorized representative) must have the ability to understand the requirements of the study, have provided written informed consent as evidenced by signature on an informed consent form (ICF) approved by an Institutional Review Board/Independent Ethics Committee (IRB/IEC) ,must have the ability to understand the requirements of the study);
• 2\. The patient must be 18 to 70 years of age at the time of consent;
• 3\. Must have a confirmed diagnosis of malignancy of their receptive histologies or cytology: unresectable recurrent or metastatic cervical carcinomas and previously received≥ 1 prior systemic therapy;
• 4\. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;
• 5\. Expected survival time of ≥ 12 weeks;
• 6\. Adequate normal organ and marrow function;
• 7\. Before tumor resection, the confirmatory imaging of disease progress since last treatment should be documented.
• 8.Patients must have measurable disease measured by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria (in addition to the resected lesion).

Критерии исключения

• 1.Patients with uncontrollable tumor-related pain as judged by the investigator; participants requiring painkiller must already have had a stable pain management options at the time of study entry; symptomatic lesions suitable for palliative radiotherapy should be completed prior to study entry;
• 2.Patients who have psychiatric disorders, alcohol, drug or substance abuse;
• 3.Women who are pregnant or breastfeeding, or planning to become pregnant within 1 year after cell infusion;
• 4.Participate in other clinical trials within 4 weeks prior to screening, or planning to participate in this study and other clinical trials at the same time;
• 5.Any other conditions that would make the patient unsuitable candidate for the study at the discretion of the investigator.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 24 центра

• The Fifth Medical Center of the General Hospital of the People's Liberation Army of China — Пекин
• Fujian Cancer Hospital — Фучжоу
• Chinese Academy of Medical Sciences Cancer Hospital Shenzhen Hospital — Шэньчжэнь
• Guangxi Medical University Affiliated Cancer Hospital — Guilin
• Harbin Medical University Affiliated Cancer Hospital — Ha’erbin
• The First Affiliated Hospital of Henan University of Science and Technology — Luoyang
• Henan Cancer Hospital — Чжэнчжоу
• Hubei Cancer Hospital — Ухань
• … и ещё 16 центров

Идентификаторы

NCT: NCT06241781 · GT-CD-CHN-101-02

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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