Esta página se tradujo automáticamente y no se garantiza la precisión de la traducción. por favor refiérase a versión inglesa para un texto fuente.

Quimioterapia perioperatoria con radioterapia de baja dosis y tislelizumab para el adenocarcinoma gástrico o de la unión gastroesofágica localmente avanzado

3 de noviembre de 2026 actualizado por: Gang Li, Jiangsu Cancer Institute & Hospital

Un ensayo de fase II multicéntrico, aleatorizado y controlado de quimioterapia perioperatoria combinada con radioterapia de baja dosis y tislelizumab frente a quimioterapia sola en pacientes con adenocarcinoma gástrico localmente avanzado o de la unión gastroesofágica

This study is a prospective, multicenter, randomized, phase II clinical trial enrolling patients with resectable locally advanced gastric or gastroesophageal junction adenocarcinoma. The study aims to compare the efficacy and safety of perioperative chemotherapy combined with low-dose radiotherapy and tislelizumab versus perioperative chemotherapy alone in this patient population.

Descripción general del estudio

Tipo de estudio

Intervencionista

Inscripción (Estimado)

114

Fase

  • Fase 2

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: Gang Li, PhD. MD.
  • Número de teléfono: +8618351992292
  • Correo electrónico: Ligang@njmu.edu.cn

Ubicaciones de estudio

    • Jiangsu
      • Nanjing, Jiangsu, Porcelana, 210009
        • Reclutamiento
        • Jiangsu Cancer Institute & Hospital
        • Contacto:
          • Gang Li, PhD. MD.
          • Número de teléfono: +8618351992292
          • Correo electrónico: Ligang@njmu.edu.cn
        • Investigador principal:
          • Gang Li, PhD. MD.

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

20 años a 80 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

1.Voluntary participation with written informed consent obtained; 2. Histologically confirmed gastric or gastroesophageal junction adenocarcinoma (Siewert type II/III) by endoscopic biopsy (pathology from outside institutions must be reviewed by the study center); 3. Staged as cT1-2N1-3M0 or cT3-4aN0-3M0 according to the AJCC 8th edition, based on endoscopy and imaging (CT, MRI, or PET-CT); 4. Age ≥20 and ≤80 years, male or female; ECOG performance status of 0-1; 5. Presence of measurable and/or non-measurable disease per RECIST v1.1; 6.No prior systemic antitumor therapy, including chemotherapy, radiotherapy, targeted therapy, immunotherapy, biologic therapy, local therapy, or investigational agents; Adequate organ function (no blood products or growth factors within 2 weeks prior to screening); 7. Women of childbearing potential must have a negative pregnancy test within 72 hours prior to first dosing and agree to use effective contraception during the study and for 5 months after the last dose; men with partners of childbearing potential must use effective contraception during the study and for 7 months after the last dose.

Exclusion Criteria:

  1. History of surgery for gastric or gastroesophageal junction tumors;
  2. Prior history of fistula formation caused by invasion of the primary tumor; 3.High risk of gastrointestinal bleeding or perforation;

4.Poor nutritional status, defined as BMI <18.5 kg/m² or PG-SGA score ≥9; 5. Major surgery or severe trauma within 4 weeks prior to first study drug administration; Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage; 6. Prior or ongoing treatment with anti-PD-1/PD-L1 antibodies, chemotherapy, radiotherapy, or targeted therapy; 7. Use of any investigational drug within 4 weeks prior to first study drug administration; Requirement for systemic corticosteroids; 8. Prior receipt of antitumor vaccines or live vaccines within 4 weeks before first study drug administration; 9. Active autoimmune disease or history of autoimmune disease; 10.History of immunodeficiency, including HIV infection, other acquired or congenital immunodeficiency, solid organ transplantation, or allogeneic bone marrow transplantation; 11.Any condition requiring systemic corticosteroid or immunosuppressive therapy within 14 days prior to treatment, except for minimal systemic absorption routes or short-term (≤7 days) prophylactic use; 12.Uncontrolled clinically significant cardiac disease, including NYHA class II or higher heart failure, unstable angina, myocardial infarction within 1 year, or clinically significant arrhythmias requiring intervention; 13.Severe infection (CTCAE grade >2) within 4 weeks prior to treatment, including infections requiring hospitalization; evidence of active pulmonary infection at baseline imaging or infections requiring antibiotics within 2 weeks prior to enrollment (prophylactic antibiotics excluded); 14.History of interstitial lung disease, noninfectious pneumonitis, pulmonary fibrosis, or other uncontrolled acute pulmonary disease; 15.Active tuberculosis, history of active tuberculosis within 1 year prior to enrollment, or inadequately treated tuberculosis more than 1 year prior; 16.Active hepatitis B (HBV DNA ≥2,000 IU/mL) or hepatitis C infection (HCV antibody positive with detectable HCV RNA); 17.Any condition requiring systemic corticosteroid or immunosuppressive therapy within 14 days prior to treatment, except for minimal systemic absorption routes or short-term (≤7 days) prophylactic use; 18.Uncontrolled clinically significant cardiac disease, including NYHA class II or higher heart failure, unstable angina, myocardial infarction within 1 year, or clinically significant arrhythmias requiring intervention; 19.Severe infection (CTCAE grade >2) within 4 weeks prior to treatment; History of interstitial lung disease, noninfectious pneumonitis, pulmonary fibrosis, or other uncontrolled acute pulmonary disease; 20.Active tuberculosis, history of active tuberculosis within 1 year prior to enrollment, or inadequately treated tuberculosis more than 1 year prior; 21.Active hepatitis B (HBV DNA ≥2,000 IU/mL) or hepatitis C infection (HCV antibody positive with detectable HCV RNA); 22.Grade >1 abnormalities in serum sodium, potassium, or calcium within 2 weeks prior to enrollment that cannot be corrected with treatment.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador activo: Quimioterapia

Chemotherapy: Oxaliplatin 130 mg/m² on days 1 and 22 plus capecitabine 1000 mg/m² twice daily on days 1-14, for a total of 3 cycles.

Experimental: Quimioterapia combinada con Tislelizumab

Chemotherapy: Oxaliplatin 130 mg/m² on days 1 and 22 plus capecitabine 1000 mg/m² twice daily on days 1-14, for a total of 3 cycles.Tislelizumab: 200 mg administered concurrently with chemotherapy on days 1 and 22 via intravenous infusion, for a total of 3 cycles. Low Dose Radiotherapy: Initiated within one week after the start of chemotherapy; total dose (DT): 30 Gy.

Radiotherapy: Initiated within one week after the start of chemotherapy; total dose (DT): 30 Gy.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Pathological Complete Response (pCR) Rate (ITT Population)
Periodo de tiempo: At the time of surgery following completion of neoadjuvant therapy, based on pathological evaluation of the resected surgical specimen.

The pathological complete response (pCR) rate is defined as the proportion of patients in the intention-to-treat (ITT) population who achieve pathological complete response after neoadjuvant treatment. Pathological complete response is defined as the absence of residual viable tumor cells in the resected primary tumor and all sampled regional lymph nodes (ypT0N0), as determined by histopathological examination of the surgical specimens according to standardized pathological assessment criteria.

At the time of surgery following completion of neoadjuvant therapy, based on pathological evaluation of the resected surgical specimen.

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Pathological Complete Response (pCR) Rate (Surgical Population)
Periodo de tiempo: At the time of surgery following completion of neoadjuvant therapy, based on pathological evaluation of the resected surgical specimen.

The pathological complete response (pCR) rate in the surgical population is defined as the proportion of patients who undergo surgical resection and achieve pathological complete response after neoadjuvant treatment. Pathological complete response is defined as the absence of residual viable tumor cells in the resected primary tumor and all sampled regional lymph nodes (ypT0N0), as determined by histopathological examination of the surgical specimens according to standardized pathological assessment criteria.

At the time of surgery following completion of neoadjuvant therapy, based on pathological evaluation of the resected surgical specimen.
R0 Resection Rate
Periodo de tiempo: At the time of surgery, based on pathological evaluation of the resected surgical specimen.

The R0 resection rate is defined as the proportion of patients who undergo surgical resection and achieve microscopically margin-negative resection (R0). R0 resection is defined as no residual tumor at the resection margins on histopathological examination of the surgical specimen, as assessed according to standard pathological criteria.

At the time of surgery, based on pathological evaluation of the resected surgical specimen.
Event-Free Survival (EFS)
Periodo de tiempo: From the date of randomization until the occurrence of disease progression, recurrence, death, or end of follow-up, whichever occurs first, assessed up 60 months.

Event-free survival (EFS) is defined as the time from randomization (or from treatment initiation in single-arm studies) to the first occurrence of any of the following events: disease progression precluding surgical resection, local or distant recurrence after surgery, or death from any cause. Patients who do not experience any of these events at the time of analysis will be censored at the date of the last disease assessment.

From the date of randomization until the occurrence of disease progression, recurrence, death, or end of follow-up, whichever occurs first, assessed up 60 months.
Overall Survival (OS)
Periodo de tiempo: From the date of randomization until death from any cause or end of follow-up, whichever occurs first, assessed up to 60 months.

Overall survival (OS) is defined as the time from randomization to death from any cause. Patients who are alive at the time of analysis will be censored at the date of last follow-up.

From the date of randomization until death from any cause or end of follow-up, whichever occurs first, assessed up to 60 months.

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Investigadores

  • Investigador principal: Gang Li, PhD. MD., Jiangsu Cancer Institute & Hospital

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

14 de mayo de 2026

Finalización primaria (Estimado)

20 de febrero de 2029

Finalización del estudio (Estimado)

20 de febrero de 2031

Fechas de registro del estudio

Enviado por primera vez

6 de febrero de 2026

Primero enviado que cumplió con los criterios de control de calidad

12 de febrero de 2026

Publicado por primera vez (Actual)

13 de febrero de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

6 de noviembre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

3 de noviembre de 2026

Última verificación

1 de noviembre de 2026

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • GAS-Jiangsu04

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

producto fabricado y exportado desde los EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

Suscribir