- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07607210
A Clinical Study of SHR-1701 Combined With Chemotherapy for the Perioperative Treatment of Locally Advanced Resectable Siewert Type II Adenocarcinoma of the Esophagogastric Junction
Descripción general del estudio
Estado
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- Fase 2
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Ziqiang Tian
- Número de teléfono: 18531118000
- Correo electrónico: tizq12@vip.163.com
Ubicaciones de estudio
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Hebei
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Shijiazhuang, Hebei, Porcelana
- The Fourth Hospital of Hebei Medical University
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Contacto:
- Ziqiang Tian
- Número de teléfono: +8618531118000
- Correo electrónico: tizq12@vip.163.com
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-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
1.Age:18-75 years old, male or female; 2.Pathologically confirmed Siewert Type II adenocarcinoma of the gastroesophageal junction; 3.Clinical stage cT3-4aN1-3M0; 4.Low to moderate HER2 expression or no expression (IHC 2+ and FISH- / IHC 1+ / IHC -); 5.Eastern Cooperative Oncology Group (ECOG) performance status of 0-1; 6.At least one measurable lesion (according to RECIST 1.1 criteria); 7.Expected survival ≥ 3 months; 8.Normal functioning of major organs, i.e. meeting the following criteria:
routine blood tests:
- HB≥90g/L;
- ANC≥1.5×109/L;
- PLT≥100×109/L;
biochemical examination:
- ALT and AST<2.5ULN(liver metastasis: ALT and AST<5ULN);
- TBIL≤1.5ULN;
- Creatinine ≤1.5ULN; 9.Left ventricular ejection fraction is >50%; 10.Women of childbearing potential must have a negative pregnancy test (serum or urine) within 14 days prior to enrollment and must agree to use appropriate contraception during the observation period and for 8 weeks following the last administration of the study drug; for men, they must be surgically sterilized or agree to use appropriate contraception during the observation period and for 8 weeks following the last administration of the study drug; 11. Participants were willing to join in this study, written informed consent, good adherence and co-operation with follow up.
Exclusion Criteria:
- Known signs of active bleeding from the lesion (except for a positive fecal occult blood test);
- Diagnosis of HER2-positive adenocarcinoma of the stomach or gastroesophageal junction;
- Cardia or pyloric obstruction;
- Currently participating in an interventional clinical trial, or having received treatment with another investigational drug or device within 4 weeks prior to the first dose;
- Known hypersensitivity to any monoclonal antibody or component of a chemotherapy agent (such as tegafur or albumin-bound paclitaxel) (history of Grade 3 or higher hypersensitivity reaction);
- Previous exposure to any anti-PD-1 or anti-PD-L1, PD-L2, CD137, or CTLA-4 antibody therapy, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways;
- Receipt of an attenuated live vaccine within 4 weeks prior to the first dose of study treatment, or planned administration during the study period;
- Use of immunosuppressants or systemic corticosteroids for immunosuppressive purposes within 14 days prior to the start of study treatment (dose > 10 mg/day of prednisone or other corticosteroids of equivalent potency);
- History of active autoimmune disease requiring systemic treatment within 2 years prior to the first dose;
- Congenital or acquired immunodeficiency (e.g., HIV infection);
- The investigator determines that the subject has other factors that may affect the study results or lead to the premature termination of the study, such as alcohol abuse, substance abuse, other serious illnesses (including mental disorders) requiring concomitant treatment, severe laboratory abnormalities, or family or social factors that may compromise the subject's safety;
- Pregnant or breastfeeding women;
- Evidence of medical history or disease that may interfere with trial results or prevent the subject from participating in the study throughout its duration, abnormal treatment or laboratory test results, or other circumstances deemed by the investigator to make the subject unsuitable for enrollment; or other potential risks identified by the investigator that render the subject unsuitable for participation in this study.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: SHR-1701+SOX
SHR-1701: 1800mg, iv, d1, q3w; SOX: S-1:40 mg (BSA<1.25 m2) , 50 mg (BSA1.25-1.5 m2) , or 60 mg (BSA≥ 1.5 m2) , po bid d1-14; Oxaliplatin:130 mg/m2 IV D1;
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SHR-1701: 1800mg, iv, d1, q3w; SOX: S-1:40 mg (BSA<1.25 m2) , 50 mg (BSA1.25-1.5 m2) , or 60 mg (BSA≥ 1.5 m2) , po bid d1-14; Oxaliplatin:130 mg/m2 IV D1;
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
pathological Complete Response(pCR)
Periodo de tiempo: 1-year
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No residual invasive cancer cells were found under microscopic examination of the resected tumor tissue and regional lymph node samples.
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1-year
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R0 resection rate
Periodo de tiempo: 1-year
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The tumor was completely removed during surgery, and microscopic examination of the resected tissue margins revealed no residual cancer cells.
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1-year
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Major Pathological Response(MPR)
Periodo de tiempo: 1-year
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Following neoadjuvant therapy, the proportion of viable tumor cells observed under a microscope in the surgically resected specimen is ≤10%.
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1-year
|
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PFS(Progression-Free Survival)
Periodo de tiempo: 3 years
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The time from the start of treatment until tumor progression or death from any cause.
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3 years
|
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OS(Overall Survival )
Periodo de tiempo: 3 years
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Time from enrollment to death from any cause.
For subjects who were still alive at the time of the last follow-up, their overall survival was censored on the date of the last follow-up.
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3 years
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Ziqiang Tian, Hebei Medical University Fourth Hospital
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- AZL-EJC
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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