A Phase III Clinical Study of Adebrelimab Combined With Concurrent Chemoradiotherapy Versus Placebo Combined With Concurrent Chemoradiotherapy for the Treatment of Locally Advanced Cervical Cancer

Официальное название

A Randomized, Controlled, Double-blind, Multicenter Phase III Clinical Study of Adebrelimab Combined With Concurrent Chemoradiotherapy Versus Placebo Combined With Concurrent Chemoradiotherapy for the Treatment of Locally Advanced Cervical Cancer

Обзор

This study aims to evaluate the efficacy of Adebrelimab plus concurrent chemoradiotherapy compared with placebo plus concurrent chemoradiotherapy for the treatment of locally advanced cervical cancer by evaluating progression-free survival (PFS).

Вмешательства

• Препарат SHR-1316 Injection
  SHR-1316 injection.
• Препарат Cisplatin Injection
  Cisplatin injection.
• Препарат Carboplatin Injection
  Carboplatin injection.
• Препарат Paclitaxel Injection
  Paclitaxel injection.
• Препарат SHR-1316 Placebo Injection
  SHR-1316 placebo injection.

Первичные конечные точки

• Progression-free survival (PFS) [Срок оценки: Up to approximately 36 months.]

Вторичные конечные точки (10)

• Overall survival (OS) [Срок оценки: Up to approximately 60 months.]
• 3-year overall survival (OS) rate [Срок оценки: Up to approximately 60 months.]
• 2-year progression-free survival (PFS) [Срок оценки: Up to approximately 24 months.]
• Objective Response Rate (ORR) [Срок оценки: Up to approximately 36 months.]
• Duration of response (DoR) [Срок оценки: Up to approximately 60 months.]
• Local recurrence rate [Срок оценки: Up to approximately 36 months.]
• Distant metastasis rate [Срок оценки: Up to approximately 60 months.]
• The second disease progression assessed by the investigator [Срок оценки: Up to approximately 60 months.]
• Adverse events (AEs) including incidence and grade correlation with study drugs [Срок оценки: Up to approximately 60 months.]
• Rate of suspension and discontinuation due to an adverse event correlation with study drugs [Срок оценки: Up to approximately 60 months.]

Критерии участия

Критерии включения

• Participate in the study voluntarily, sign the informed consent form.
• Subjects were able to provide primary or metastatic cancer samples.
• At least one measurable lesion.
• Expected survival > 3 months.
• ECOG 0 \~ 1.
• With adequate organ functions.

Критерии исключения

• Pathologically or radiologically confirmed presence of distant metastatic disease, including lymph nodes above the first lumbar vertebra (L1) (cephalad) or in the inguinal region.
• Administering live vaccines within 4 weeks before enrollment or during planned study treatment.
• Participants who received immunosuppressive therapy within 4 weeks before enrolment.
• For participants who are receiving thrombolytic/anticoagulant therapy, prophylactic anticoagulant therapy is allowed.
• Participants who have had other uncured malignant tumors in the past (within 5 years) or concurrently have had other uncured malignant tumors, excluding cured basal cell carcinoma of the skin and carcinoma in situ.
• Known allergy to the investigational drug or any of its excipients; or severe allergic reaction to other monoclonal antibodies.
• Pregnant or breastfeeding women.
• According to the investigator's judgment, there are diseases or any other conditions that may seriously endanger the safety of the subjects, may confound the research results, or affect the subjects' ability to complete the study.

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

Четверное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Fudan University Shanghai Cancer Center — Шанхай

Идентификаторы

NCT: NCT07168200 · SHR-1316-305

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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