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Neoadjuvant and Adjuvant Therapy Studies of Sintilimab Combined With Chemotherapy With or Without Ipilimumab N01 in Resectable Gastric/Gastroesophageal Junction Adenocarcinoma

12 de agosto de 2026 actualizado por: Innovent Biopharmaceutical Technology (Hangzhou) Co., LTD.

A Randomized, Double-Blind, Phase II/III Clinical Study of the Efficacy and Safety of Sintilimab Combined With Chemotherapy With or Without Ipilimumab N01 in Perioperative Treatment of Resectable Gastric/Gastroesophageal Junction Adenocarcinoma

This is a Randomized, Double-Blind, Phase II/III Clinical Study of the Efficacy and Safety of Sintilimab Combined with Chemotherapy With or Without Ipilimumab N01 in Perioperative Treatment of Resectable Gastric/Gastroesophageal Junction Adenocarcinoma.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Estimado)

720

Fase

  • Fase 2
  • Fase 3

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

Ubicaciones de estudio

  • Porcelana
    • Guangdong
      • Guangzhou, Guangdong, Porcelana, 510060
        • Reclutamiento
        • Sun Yat-sen University Cancer Center
        • Contacto:

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

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

Inclusion Criteria

  1. Signed written Informed Consent Form (ICF) and ability to comply with protocol-specified visits and related procedures.
  2. Age ≥ 18 years.
  3. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
  4. Expected survival ≥ 6 months.
  5. Histologically confirmed adenocarcinoma of the stomach or gastroesophageal junction (GEJ). For GEJ cancer, only Siewert type III and Siewert type II participants not requiring combined thoracotomy are eligible.
  6. Clinical stage T3-4Nany or TanyN+M0 (stage II-IVa) gastric/GEJ adenocarcinoma confirmed by endoscopic ultrasound or contrast-enhanced CT/MRI within 4 weeks before the first dose, per the American Joint Committee on Cancer (AJCC) 8th edition gastric cancer TNM staging system.
  7. Within 4 weeks before the first dose, evaluated by a responsible surgeon based on medical history and confirmed to meet study requirements for radical R0 resection.

Exclusion Criteria

  1. Histologically or cytologically confirmed other pathologic types (e.g., squamous cell carcinoma, sarcoma, undifferentiated carcinoma) or combined gastrointestinal stromal tumor (GIST) before randomization.
  2. Suspicious metastatic lesions or locally advanced unresectable disease, regardless of stage.
  3. History of gastrointestinal perforation or fistula within 6 months before randomization. May be enrolled if perforation/fistula has been surgically treated (repaired/resected) and disease recovery/remission is confirmed by the investigator.
  4. Active diverticulitis, intra-abdominal abscess, or gastrointestinal obstruction.
  5. Inability to swallow, malabsorption syndrome, or uncontrolled nausea/vomiting/diarrhea, or other severe gastrointestinal diseases affecting drug intake/absorption.
  6. Any life-threatening bleeding event within 3 months before randomization, or grade 3/4 gastrointestinal/variceal bleeding requiring endoscopic/surgical intervention.
  7. Active uncontrolled bleeding or known bleeding diathesis.

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: Único

Armas e Intervenciones

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

Neoadjuvant Treatment period: up to 3 cycles of sintilimab plus chemotherapy in combination with Ipilimumab N01 prior to surgery.

adjuvant Treatment period: Subjects will receive 5 cycles of sintilimab plus chemotherapy, and then receive sintilimab therapy after surgery until disease recurrence, unacceptable toxicity, receiving new anti-tumor therapy, withdrawal of informed consent (ICF), lost to follow-up or death, or other conditions that require treatment discontinuation (whichever occurs first). The maximum duration of postoperative treatment with either sintilimab or placebo is 13 cycles.
Droga: tegafur, Gimeracil and Oteracil Potassium Capsules
40mg/m2, D1-14 BID PO Q3W
Droga: Sintilimab
200mg D1 IV Q3W
Droga: Oxaliplatin for injection
130 mg/m2 D1 IV Q3W
Droga: Ipilimumab N01 Placebo
1mg/kg, D1 IV Q6W
Experimental: Sintilimab+Ipilimumab N01

Neoadjuvant Treatment period: up to 3 cycles of sintilimab plus chemotherapy in combination with Ipilimumab N01 prior to surgery.

adjuvant Treatment period: Subjects will receive 5 cycles of sintilimab plus chemotherapy, and then receive sintilimab therapy after surgery until disease recurrence, unacceptable toxicity, receiving new anti-tumor therapy, withdrawal of informed consent (ICF), lost to follow-up or death, or other conditions that require treatment discontinuation (whichever occurs first). The maximum duration of postoperative treatment with either sintilimab or placebo is 13 cycles.
Droga: tegafur, Gimeracil and Oteracil Potassium Capsules
40mg/m2, D1-14 BID PO Q3W
Droga: Sintilimab
200mg D1 IV Q3W
Droga: Oxaliplatin for injection
130 mg/m2 D1 IV Q3W
Droga: Ipilimumab N01
1mg/kg, D1 IV Q6W
Comparador activo: Sintilimab placebo+Ipilimumab N01 placebo

Neoadjuvant Treatment period: up to 3 cycles of sintilimab placebo plus chemotherapy in combination with Ipilimumab N01 Placebo prior to surgery.

adjuvant Treatment period: Subjects will receive 5 cycles of sintilimab placebo plus chemotherapy, and then receive sintilimab placebo therapy after surgery until disease recurrence, unacceptable toxicity, receiving new anti-tumor therapy, withdrawal of informed consent (ICF), lost to follow-up or death, or other conditions that require treatment discontinuation (whichever occurs first). The maximum duration of postoperative treatment with either sintilimab or placebo is 13 cycles.
Droga: tegafur, Gimeracil and Oteracil Potassium Capsules
40mg/m2, D1-14 BID PO Q3W
Droga: Oxaliplatin for injection
130 mg/m2 D1 IV Q3W
Droga: Ipilimumab N01 Placebo
1mg/kg, D1 IV Q6W
Droga: Sintilimab Placebo
200 mg, D1 IV Q3W

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Major Pathological Response (MPR) rate in Resectable Gastric/Gastroesophageal Junction Adenocarcinoma
Periodo de tiempo: Up to approximately 6 weeks following the beginning of Post-operative Assessment baseline(up to Study 2 years )
The MPR rate is defined as the proportion of participants with a Tumor Regression Grade (TRG) score of 0 or 1 in the primary tumor after radical surgical resection following neoadjuvant therapy.
Up to approximately 6 weeks following the beginning of Post-operative Assessment baseline(up to Study 2 years )
Event-Free Survival (EFS)
Periodo de tiempo: Up to approximately 5 years
The EFS is defined as the time from randomization to the first occurrence of disease progression precluding curative resection, postoperative local recurrence, distant metastasis, or death from any cause.
Up to approximately 5 years

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Supervivencia global (SG)
Periodo de tiempo: Hasta 5 años aproximadamente
La OS se define como el tiempo desde la aleatorización hasta la muerte por cualquier causa.
Hasta 5 años aproximadamente
pathological Complete Response (pCR) rate
Periodo de tiempo: Up to approximately 6 weeks following the beginning of Post-operative Assessment baseline(up to Study 2 years )
The pCR rate is defined as the proportion of participants with no residual viable tumor in both the primary tumor and lymph nodes after radical surgical resection following neoadjuvant therapy.
Up to approximately 6 weeks following the beginning of Post-operative Assessment baseline(up to Study 2 years )
Clinical Down-staging Rate
Periodo de tiempo: Up to approximately 6 weeks following the beginning of Post-operative Assessment baseline(up to Study 2 years )
Clinical downstaging rate refers to the proportion of participants with a reduction in clinical TNM (cTNM) stage after neoadjuvant therapy.
Up to approximately 6 weeks following the beginning of Post-operative Assessment baseline(up to Study 2 years )
R0 resection rate
Periodo de tiempo: Up to approximately 6 weeks following the beginning of Post-operative Assessment baseline(up to Study 2 years )
The R0 resection rate is defined as the proportion of participants who underwent R0 resection.
Up to approximately 6 weeks following the beginning of Post-operative Assessment baseline(up to Study 2 years )
numbers of subjects with adverse events
Periodo de tiempo: Up to approximately 5 years
defined as any untoward medical occurrence, whether or not there is a causal relationship with the study drug, in a clinical study subject from the time informed consent form is signed
Up to approximately 5 years
numbers of subjects with serious adverse events
Periodo de tiempo: Up to approximately 5 years
Defined as any serious untoward medical occurrence, whether or not there is a causal relationship with the study drug, in a clinical study subject from the time informed consent form is signed
Up to approximately 5 years

Colaboradores e Investigadores

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

Patrocinador

Innovent Biopharmaceutical Technology (Hangzhou) Co., LTD.

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)

31 de julio de 2026

Finalización primaria (Estimado)

31 de diciembre de 2031

Finalización del estudio (Estimado)

31 de diciembre de 2031

Fechas de registro del estudio

Enviado por primera vez

4 de junio de 2026

Primero enviado que cumplió con los criterios de control de calidad

9 de junio de 2026

Publicado por primera vez (Actual)

11 de junio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

14 de agosto de 2026

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

12 de agosto de 2026

Última verificación

1 de agosto de 2026

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • CIBI310M301

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

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. .

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