Serplulimab for Locally Advanced Cervical Cancer

Официальное название

Chemoradiotherapy Combined With Serplulimab for Locally Advanced Cervical Cancer: A Prospective, Multicenter, Randomized, Phase II Clinical Trial

Обзор

This study is a randomized, controlled, open-label, phase II clinical trial designed to enroll patients with previously untreated locally advanced cervical cancer. The study aims to evaluate the efficacy and safety of adding chemotherapy to serplulimab combined with concurrent chemoradiotherapy. The primary endpoint of this study is progression-free survival (PFS).

Подробное описание

This study is a randomized, controlled, open-label, phase II clinical trial designed to evaluate the efficacy and safety of serplulimab in combination with chemotherapy and concurrent chemoradiotherapy in patients with locally advanced cervical cancer. Eligible patients are women aged 18-75 years with FIGO 2014 (International Federation of Gynecology and Obstetrics) stage IB2-IIB disease with lymph node positivity or stage III-IVA disease. Patients will be randomly assigned to two groups. Patients in the control group will receive serplulimab immunotherapy combined with concurrent chemoradiotherapy, followed by maintenance serplulimab for up to 2 years. Patients in the experimental group will receive, in addition to the above treatment, two cycles of induction chemotherapy and four cycles of consolidation chemotherapy, consisting of paclitaxel and platinum-based agents. The primary endpoint of this study is progression-free survival (PFS), which will be assessed by investigators according to RECIST version 1.1.

Вмешательства

• Препарат Serplulimab
  intravenous infusion of 300 mg, administered every 3 weeks as one cycle, on the first day of each cycle, with a maximum treatment duration of 2 years (up to 35 treatment cycles)
• Лучевая терапия radiotherapy
  Pelvic external beam radiotherapy was delivered with a prescribed dose of 45.0-50.4 Gy in 25-28 fractions to the PTV, administered once daily, five days per week; the PGTVnd received a simultaneous integrated boost to 53.50-59.92 Gy in 25-28 fractions. During radiotherapy, concurrent chemotherapy with weekly cisplatin was administered. Brachytherapy was delivered with 28 Gy in 4 fractions, prescribed to the 100% isodose line covering the CTV.
• Препарат Chemotherapy
  Two cycles of induction chemotherapy were administered prior to concurrent chemoradiotherapy, consisting of cisplatin 60-75 mg/m² on days 1 and 2 of each cycle, once every 3 weeks (21 days), and nab-paclitaxel 135-175 mg/m² by intravenous infusion on day 1 of each cycle, once every 3 weeks (21 days). After completion of concurrent chemoradiotherapy, patients received four cycles of consolidation chemotherapy using the same cisplatin and nab-paclitaxel regimen as above.

Первичные конечные точки

• PFS [Срок оценки: through study completion, an average of 2 year]
• OS [Срок оценки: through study completion, an average of 2 year]

Вторичные конечные точки (1)

• safety assessment [Срок оценки: through study completion, an average of 2 year]

Критерии участия

Критерии включения

• Voluntarily willing to participate in the clinical study, fully informed about the study, and signed the informed consent form (ICF);
• Willing and able to comply with all study procedures;
• Female aged 18-75 years;
• ECOG performance status of 0 or 1;
• PD-L1 status not restricted;
• Histologically confirmed cervical squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma;
• FIGO 2014 (International Federation of Gynecology and Obstetrics) stage IB2-IIB with positive lymph nodes, or stage III-IVA;
• Patients must meet the following hematologic, renal, and hepatic function criteria:
• Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L; Platelet count ≥ 100 × 10⁹/L; Total bilirubin, alanine aminotransferase (ALT), and aspartate aminotransferase (AST) ≤ 1.5 × upper limit of normal (ULN); Serum creatinine ≤ upper limit of normal (ULN); No prior anti-tumor treatment; Expected survival > 6 months;
• Female subjects must have a negative serum pregnancy test within 14 days prior to study treatment, agree to use effective contraception during treatment and for 6 months after treatment, and breastfeeding is prohibited during the study.

Критерии исключения

• Histologically confirmed small cell cervical cancer;
• Recurrent cervical cancer or presence of distant metastases;
• Prior anti-tumor treatment;
• Current or history of another active, untreated malignancy within the past 5 years, except for adequately treated basal cell carcinoma of the skin or carcinoma in situ;
• Any active or known autoimmune disease;
• Active infection;
• Requirement for systemic treatment with corticosteroids or other immunosuppressive agents within 14 days prior to randomization;
• Arterial or venous thromboembolic events within 6 months prior to enrollment;
• Uncontrolled clinically significant cardiac symptoms or disease;
• Known allergy to the investigational drug or any of its excipients, or prior severe allergic reaction to other monoclonal antibodies;
• Pregnant or breastfeeding women;
• Neurological or psychiatric abnormalities affecting cognitive function;
• Any other condition or situation that, in the investigator's judgment, would pose a serious risk to the subject's safety, potentially confound study results, or interfere with the subject's 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

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Tianjin Medical University Cancer Institute & Hospital, — Тяньцзинь

Идентификаторы

NCT: NCT07340489 · E20251312

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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