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El ensayo clínico NCT07340489 para Cáncer de cuello uterino está reclutando. Consulte la vista de tarjeta del Radar de Ensayos Clínicos y las herramientas de descubrimiento de IA para conocer todos los detalles. O haga cualquier pregunta aquí.
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Serplulimab for Locally Advanced Cervical Cancer Fase II 216 Aleatorizado Etiqueta abierta

Reclutando
Los detalles del ensayo clínico están disponibles principalmente en inglés. ¡Sin embargo, IA Trial Radar puede ayudar! Simplemente haga clic en 'Explicar el estudio' para ver y discutir la información del estudio en el idioma que haya seleccionado.
El ensayo clínico NCT07340489 está diseñado para estudiar el tratamiento de Cáncer de cuello uterino. Es un estudio intervencionista de Fase II. Su estado actual es: reclutando. El estudio se inició el 3 de diciembre de 2025, con el objetivo de reclutar a 216 participantes. Dirigido por la Universidad Médica de Tianjin, se espera que finalice el 30 de noviembre de 2027. Los datos se actualizaron por última vez en ClinicalTrials.gov el 14 de enero de 2026.
Resumen
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).
Descripción detallada
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...Mostrar más
Título oficial

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

Condiciones médicas
Cáncer de cuello uterino
Otros ID del estudio
  • E20251312
Número del NCT
NCT07340489
Inicio del estudio (real)
2025-12-03
Última actualización
2026-01-14
Fecha de finalización (estimada)
2027-11-30
Inscripción (prevista)
216
Tipo de estudio
Intervencionista
FASE
Fase II
Estado general
Reclutando
Palabras clave
cervical cancer
immunotherapy
chemoradiotherapy
Objetivo principal
Tratamiento
Método de asignación
Aleatorizado
Modelo de intervención
Paralelo
Enmascaramiento
Ninguno (Abierto)
Brazos / Intervenciones
Grupo de participantesIntervención/Tratamiento
ExperimentalExperimental: chemotherapy combined with immunotherapy and radiotherapy
chemotherapy an Serplulimab plus chemoradiotherapy group
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)
Radioterapia
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% iso...Mostrar más
Quimioterapia
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 th...Mostrar más
Comparador placeboControl group: immunotherapy and radiotherapy
Serplulimab plus chemoradiotherapy group
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)
Radioterapia
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% iso...Mostrar más
Resultado primario
Medida de resultadoDescripción de la medidaPeriodo de tiempo
PFS
defined as the time from randomization to the first occurrence of disease progression or death from any cause.
through study completion, an average of 2 year
OS
The time from random assignment to death because of any cause.
through study completion, an average of 2 year
Resultado secundario
Medida de resultadoDescripción de la medidaPeriodo de tiempo
safety assessment
Adverse events occurring throughout the study period will be evaluated according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0.
through study completion, an average of 2 year
Asistente de participación
Criterios de elegibilidad

Criterios de edad
Adulto, Adulto mayor
Edad mínima
18 Years
Criterios de sexo
Mujer
  1. Voluntarily willing to participate in the clinical study, fully informed about the study, and signed the informed consent form (ICF);
  2. Willing and able to comply with all study procedures;
  3. Female aged 18-75 years;
  4. ECOG performance status of 0 or 1;
  5. PD-L1 status not restricted;
  6. Histologically confirmed cervical squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma;
  7. FIGO 2014 (International Federation of Gynecology and Obstetrics) stage IB2-IIB with positive lymph nodes, or stage III-IVA;
  8. Patients must meet the following hematologic, renal, and hepatic function criteria:
  9. 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;
  10. 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.

  1. Histologically confirmed small cell cervical cancer;
  2. Recurrent cervical cancer or presence of distant metastases;
  3. Prior anti-tumor treatment;
  4. 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;
  5. Any active or known autoimmune disease;
  6. Active infection;
  7. Requirement for systemic treatment with corticosteroids or other immunosuppressive agents within 14 days prior to randomization;
  8. Arterial or venous thromboembolic events within 6 months prior to enrollment;
  9. Uncontrolled clinically significant cardiac symptoms or disease;
  10. Known allergy to the investigational drug or any of its excipients, or prior severe allergic reaction to other monoclonal antibodies;
  11. Pregnant or breastfeeding women;
  12. Neurological or psychiatric abnormalities affecting cognitive function;
  13. 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.
Tianjin Medical University Cancer Institute and Hospital logoUniversidad Médica de Tianjin378 estudios activos para explorar
Contactos centrales del estudio
Contacto: Maobin Meng, Dr., +86 15202231270, [email protected]
Contacto: Ying Chen, Dr., +86 13132032398, [email protected]
1 Centros del estudio en 1 países

Tianjin Municipality

Tianjin Medical University Cancer Institute & Hospital,, Tianjin, Tianjin Municipality, 300060, China
Maobin Meng, Dr., Contacto, +86 15202231270, [email protected]
Ying Chen, Dr., Contacto, +86 13132032398, [email protected]
Reclutando