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Mannatide Combined With CAPOX and Tislelizumab for Advanced Gastric Cancer.

13 de junio de 2026 actualizado por: Ming Liu

A Multicenter, Single-Arm, Phase II Study of Mannatide Combined With CAPOX and Tislelizumab as First-Line Treatment for Recurrent or Metastatic Gastric and Gastroesophageal Junction Adenocarcinoma.

This is a multicenter, open-label, single-arm phase II study evaluating the efficacy and safety of mannatide in combination with CAPOX chemotherapy and tislelizumab as first-line treatment for patients with recurrent or metastatic gastric adenocarcinoma or gastroesophageal junction adenocarcinoma.

Eligible patients will receive oxaliplatin, capecitabine, tislelizumab, and oral mannatide. Tumor response will be assessed according to RECIST version 1.1. Patients without disease progression after induction treatment may continue maintenance therapy with capecitabine, tislelizumab, and mannatide.

The primary objective is to evaluate objective response rate (ORR). Secondary objectives include progression-free survival (PFS), overall survival (OS), disease control rate (DCR), duration of response (DoR), and safety. Exploratory analyses will investigate immune microenvironment changes and potential predictive biomarkers using blood, tumor tissue, and stool samples.

Descripción general del estudio

Estado

Aún no reclutando

Condiciones

Intervención / Tratamiento

Descripción detallada

Gastric cancer remains one of the leading causes of cancer-related mortality worldwide. Although immune checkpoint inhibitors combined with chemotherapy have improved outcomes in advanced gastric and gastroesophageal junction adenocarcinoma, many patients still fail to achieve durable responses.

Mannatide is an immunomodulatory agent that has been shown to enhance both innate and adaptive immune responses. Preclinical and clinical studies suggest that mannatide may improve antitumor immunity through activation of macrophages, enhancement of antigen presentation, stimulation of T-cell proliferation, and promotion of natural killer cell activity. These properties provide a rationale for combining mannatide with chemotherapy and immune checkpoint blockade.

This study is a multicenter, open-label, single-arm phase II trial enrolling approximately 52 patients with unresectable recurrent or metastatic gastric or gastroesophageal junction adenocarcinoma. Participants will receive CAPOX chemotherapy (oxaliplatin plus capecitabine), tislelizumab, and oral mannatide as first-line treatment.

Treatment will be administered for six induction cycles. Tumor assessments will be performed every two cycles according to RECIST version 1.1. Patients without disease progression may continue maintenance therapy consisting of capecitabine, tislelizumab, and mannatide until disease progression, unacceptable toxicity, withdrawal of consent, initiation of another anticancer therapy, death, or completion of the maximum treatment duration.

The primary endpoint is objective response rate (ORR). Secondary endpoints include progression-free survival (PFS), overall survival (OS), disease control rate (DCR), duration of response (DoR), and safety. Exploratory endpoints include single-cell RNA sequencing, single-cell T-cell receptor sequencing, multiplex immunofluorescence analysis, and gut microbiome profiling to identify biomarkers associated with treatment response.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

52

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: Ming Liu, MD
  • Número de teléfono: +8618980606324
  • Correo electrónico: liuming629@wchscu.cn

Ubicaciones de estudio

  • Porcelana
    • Sichuan
      • Chengdu, Sichuan, Porcelana, 610041
        • West China Hospital of Sichuan University
        • 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. Histologically or cytologically confirmed gastric adenocarcinoma or gastroesophageal junction adenocarcinoma, including signet ring cell carcinoma, mucinous adenocarcinoma, and hepatoid adenocarcinoma.
  2. Unresectable recurrent or metastatic disease confirmed by imaging and surgical evaluation.
  3. Age 18 to 75 years.
  4. Expected survival greater than 3 months.
  5. No prior systemic therapy for recurrent or metastatic gastric or gastroesophageal junction adenocarcinoma. Previous neoadjuvant or adjuvant therapy is allowed if completed at least 6 months before enrollment without evidence of recurrence or progression.
  6. ECOG performance status 0-1.
  7. At least one measurable lesion according to RECIST version 1.1.
  8. Availability of tumor tissue for PD-L1 testing.
  9. Adequate hematologic, hepatic, renal, and coagulation function.
  10. Recovery of prior treatment-related toxicities to Grade 0-1 or baseline level.
  11. Negative pregnancy test for women of childbearing potential and agreement to use effective contraception.
  12. Ability to understand and willingness to sign informed consent.

Exclusion Criteria:

  1. HER2-positive gastric or gastroesophageal junction adenocarcinoma.
  2. Squamous cell carcinoma, undifferentiated carcinoma, or mixed histology.
  3. Active or uncontrolled central nervous system metastases.
  4. Uncontrolled pleural effusion, ascites, or clinically significant pericardial effusion.
  5. Weight loss greater than 20% within 2 months before enrollment.
  6. Major surgery within 28 days before enrollment.
  7. Prior anti-PD-1, anti-PD-L1, anti-CTLA-4, or other immune checkpoint inhibitor therapy.
  8. Active autoimmune disease requiring systemic treatment.
  9. Active hepatitis B, hepatitis C, or HIV infection.
  10. Interstitial lung disease or uncontrolled systemic disease.
  11. Significant cardiovascular disease within 6 months before enrollment.
  12. Known hypersensitivity to study drugs or their components.
  13. Participation in another interventional clinical trial within 4 weeks before enrollment.
  14. History of substance abuse or severe psychiatric disorder.
  15. History of rheumatic heart disease or known hypersensitivity to mannatide.
  16. Any condition that, in the opinion of the investigator, would make participation unsafe or interfere with study evaluation.

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: N / A
  • Modelo Intervencionista: Asignación de un solo grupo
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: CAPOX + Tislelizumab + Mannatide
Participants will receive CAPOX chemotherapy (oxaliplatin and capecitabine), tislelizumab, and oral mannatide as first-line treatment for recurrent or metastatic gastric or gastroesophageal junction adenocarcinoma.
Droga: Oxaliplatin
Oxaliplatin 130 mg/m² administered intravenously on Day 1 of each 21-day treatment cycle as part of the CAPOX regimen.
Droga: Capecitabine
Capecitabine 1000 mg/m² orally twice daily on Days 1-14 of each 21-day treatment cycle.
Droga: Tislelizumab
Tislelizumab 200 mg administered intravenously on Day 1 of each 21-day treatment cycle.
Droga: Mannatide
Mannatide 10 mg administered orally three times daily throughout study treatment.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Objective Response Rate (ORR)
Periodo de tiempo: From treatment initiation until disease progression, assessed every 6 weeks during induction treatment and every 6 to 8 weeks during maintenance treatment, up to 24 months.
Objective response rate defined as the proportion of participants achieving a complete response (CR) or partial response (PR) according to RECIST version 1.1.
From treatment initiation until disease progression, assessed every 6 weeks during induction treatment and every 6 to 8 weeks during maintenance treatment, up to 24 months.

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Supervivencia general (SG)
Periodo de tiempo: Hasta 24 meses
Hasta 24 meses
Tasa de Control de Enfermedades (DCR)
Periodo de tiempo: Hasta 24 meses
Hasta 24 meses
Duration of Response (DoR)
Periodo de tiempo: Up to 24 months
Up to 24 months
Incidence of Adverse Events
Periodo de tiempo: From first dose through 30 days after the last dose, up to 24 months.
Adverse events assessed according to NCI CTCAE version 5.0.
From first dose through 30 days after the last dose, up to 24 months.
Quality of Life (QoL)
Periodo de tiempo: Baseline through completion of study treatment, up to 24 months.
Quality of life assessed using the EORTC QLQ-C30 questionnaire.
Baseline through completion of study treatment, up to 24 months.

Colaboradores e Investigadores

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

Patrocinador

Ming Liu

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 (Estimado)

1 de julio de 2026

Finalización primaria (Estimado)

1 de julio de 2028

Finalización del estudio (Estimado)

1 de julio de 2029

Fechas de registro del estudio

Enviado por primera vez

13 de junio de 2026

Primero enviado que cumplió con los criterios de control de calidad

13 de junio de 2026

Publicado por primera vez (Actual)

18 de junio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

18 de junio de 2026

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

13 de junio de 2026

Última verificación

1 de junio de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 2025 Review (2538)

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

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. .

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