Adjuvant Chemoradiotherapy Followed by Zimberelimab for Locally Advanced Cervical Cancer.

Официальное название

Adjuvant Chemoradiotherapy Followed by Zimberelimab for Locally Advanced Cervical Cancer (IB3, IIA2) Patients

Обзор

Locally advanced cervical cancer (stage IB3, IIA2) patients with postoperative risk factors need better treatment. We initiated a clinical study to explore the effectiveness of adjuvant chemoradiotherapy followed by Zimberelimab for these patients.

Подробное описание

For cervical cancer, although clinical research on PD-1 monoclonal antibodies was launched relatively late, the research results so far show that PD-1 monoclonal antibodies combined with chemotherapy have a high clinical effectiveness and a relatively high efficacy in the treatment of advanced/recurrent cervical cancer. Good security. However, there is currently a lack of clinical evidence for the use of PD-1 monoclonal antibodies combined with chemoradiotherapy in the treatment of high-risk patients after cervical cancer surgery. Therefore, this study intends to explore the clinical efficacy of postoperative adjuvant radiochemotherapy followed by PD-1 monoclonal antibody in the treatment of high-risk patients with locally advanced (IB3, IIA2) cervical cancer after surgery, and provide a new solution for clinical treatment.

Вмешательства

• Препарат Zimberelimab
  240mg, q3w，8 cycles
• Препарат Platinum
  cisplatin 40mg/m2 for 5-6 cycles
• Лучевая терапия radiotherapy
  45-50Gy/1.8Gy/25-28f

Первичные конечные точки

• changes in tumor-related biomarkers [Срок оценки: 3 years]

Вторичные конечные точки (3)

• OS [Срок оценки: 5 years]
• DFS [Срок оценки: 2 years]
• AE [Срок оценки: 3 years]

Критерии участия

Критерии включения

• Histologically confirmed cervical squamous cell carcinoma, cervical adenocarcinoma, or cervical adenosquamous carcinoma;
• According to FIGO2018 staging, patients with locally advanced cervical cancer (IB3, IIA2) who require concurrent radiotherapy and chemotherapy;
• Patients with radical surgery for cervical cancer;
• Female patients: 18-70 years old;
• ECOG physical condition score: 0\~1 point;
• Subjects have not received previous immunotherapy;
• Expected survival ≥6 months;
• Women of reproductive age should agree to use contraceptives (such as Iuds, contraceptives, or condoms) during the study period and for 6 months after the study ends; Have a negative serum or urine pregnancy test within 7 days prior to study enrollment and must be a non-lactating patient;
• For adequate organ function as defined in the protocol, test samples must be collected within 7 days prior to initiation of the study therapy
• Subjects voluntarily joined the study, signed informed consent, had good compliance, and cooperated with follow-up.

Критерии исключения

• Subjects have histological subtypes other than those permitted by inclusion criteria;
• Severe hypersensitivity to cepalizumab and/or any of its excipients (≥ grade 3);
• Participate in or have participated in other clinical trials within 4 weeks before enrollment;
• Have received or will receive inactivated vaccine within 30 days prior to the first study treatment;
• Received a combination of systemic immune stimulants, colony-stimulating factors, interferon, interleukin, and vaccine within 6 weeks or 5 half-lives (if shorter) prior to initial administration;
• Have been diagnosed with an immune deficiency or are receiving chronic systemic steroid therapy (doses greater than 10mg daily equivalent of prednisone) or any other form of immunosuppressive therapy within 7 days prior to the first dose;
• Have an active autoimmune disease in the past 2 years that requires systemic treatment (such as the use of disease-modulating drugs, corticosteroids, or immunosuppressive drugs);
• Have a history of (non-infectious) pneumonia requiring steroid treatment or have a current (non-infectious) pneumonia;
• An active infection requiring systematic treatment;
• Known history of HIV infection;
• A known history of hepatitis B (defined as HBsAg reactive) or known active hepatitis C virus (defined as detection of HCV RNA\[qualitative\]) infection;
• Known active tuberculosis (TB; Tuberculosis) medical history;
• Has received allogeneic tissue/solid organ transplantation;
• Suffering from central nervous system metastases such as brain metastases;
• Patients with uncontrolled chest and abdominal fluid;
• Patients with mobility disorders such as pathological fractures caused by tumor bone metastasis;
• Insufficient hematopoietic function of bone marrow;
• Abnormal liver;
• Abnormal kidney;
• Bleeding risk;
• Cardiovascular and cerebrovascular abnormalities.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06128460 · GLS-010-672

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗