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TAIC FOLFOX for Locally Advanced G/GEJA (TFLAG)

15 de junio de 2026 actualizado por: Quanda Liu, Guang'anmen Hospital of China Academy of Chinese Medical Sciences

FOLFOX-Based Transarterial Infusion Chemotherapy for Locally Advanced Gastric Cancer and Gastroesophageal Junction Adenocarcinoma: Protocol of an Open-Label, Multicentre, Single-arm, Phase Ⅱ Trial

Gastric cancer is the fifth most common malignancy worldwide in terms of both incidence and mortality. The majority of cases are diagnosed at advanced stage-often presenting with severe complications such as malignant stricture, obstruction, bleeding, and cancer-related malnutrition-which impinge on quality of life and survival outcomes. For patients with unresectable or metastatic gastric cancer and gastroesophageal junction adenocarcinoma (G/GEJA), first-line systemic therapy remains predominantly platinum- and fluoropyrimidine-based combination chemotherapy, and targeted agents or immunotherapy can be added based on the expression of biomarkers. Under this standard approach, the median overall survival (mOS) for localized unresectable G/GEJA is approximately 14-20 months. For metastatic G/GEJA, the prognosis remains poor with an mOS of less than 1 year, despite the proven efficacy of chemotherapeutic agents. Moreover, up to 25% of cancer survivors report a significant decline in quality of life due to gastrointestinal symptoms during, soon after, or many years after treatment.

Interventional oncology approaches-including trans-arterial infusion chemotherapy (TAIC), embolization (TAE), and chemoembolization (TACE)-represent promising locoregional therapeutic strategies. TAIC allows for the direct delivery of cytotoxic agents into the tumor-feeding arteries, thereby maximizing intra-tumoral drug concentration. As one of the most well-recognized applications, hepatic arterial infusion chemotherapy (HAIC) has been demonstrated in liver cancer by elevating local drug exposure, markedly enhancing antitumor efficacy while minimizing systemic adverse effects. Moreover, chemotherapeutic agents may exert secondary systemic activity against clinically or subclinically disseminated metastases upon systemic circulation, contributing to a sustained "secondary chemotherapy" effect. Owing to its favorable safety profile and preserved antitumor activity, TAIC is particularly suited for frail or elderly patients who are ineligible for surgery or conventional systemic chemotherapy.

Given the persistent limitations of current therapeutic paradigms, the feasibility and safety of trans-arterial therapy in the treatment of anti-tumor, hemostasis and obstruction relief for locally advanced G/GEJC remains urgent. The present study aimed to assess the efficacy and safety of TAIC for locally advanced G/GEJA.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Estimado)

31

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: Yan Sun, PhD
  • Número de teléfono: +86 15010797262
  • Correo electrónico: 632739616@qq.com

Copia de seguridad de contactos de estudio

Ubicaciones de estudio

  • Porcelana
      • Beijing, Porcelana
        • Reclutamiento
        • Department of General Surgery, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, No. 5 Beixiange St, West-city District, Beijing, China
        • Contacto:
          • Yan Sun, PhD
          • Número de teléfono: +86 15010797262
          • Correo electrónico: 6327391616@qq.com

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:

  • Age ≥ 18 years
  • Pathologically diagnosed with G/GEJA
  • Confirmed by the surgeon as initially unresectable advanced G/GEJC
  • Contraindicated to surgery due to frailty or comorbidities
  • Expected survival period ≥ 3 months

Exclusion Criteria:

  • Primary malignant tumors
  • Gastrointestinal obstruction caused by lesions in the distal stomach, duodenum, pancreas or other organs
  • Acute infection, severe liver or kidney dysfunction or coagulation disorder
  • Allergic to the drugs or with mental disorders

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: the TAIC group
Patients in the TAIC group will undergo FOLFOX-based TAIC at weeks 0 and 4 and receive FOLFOX-based IVC at weeks 2 and 6. The FOLFOX-based TAIC consists of oxaliplatin (85 mg/m²) administered as a 2-hour transarterial infusion, leucovorin (400 mg/m²) administered as a 2-hour transarterial infusion, and fluorouracil (2400 mg/m²) administered as a 44-hour transarterial infusion. According to the results of the genetic mutation status, HER2-positive patients are administered trastuzumab in combination every cycle.
Procedimiento: TAIC
The Seldinger method was used to insert a vascular sheath through the unilateral femoral artery. A 5 F angiographic catheter (C2, RLG, or RH TYPE, Cook Corporation, Bloomington, IN, USA) was inserted into left gastric, short gastric, and esophageal proper arteries under fluoroscopy guidance, and the condition of each branch vessel was visualized by catheter angiography. Then a 2.7 F microcatheter was introduced into the artery that delivered blood supply to the tumor using the coaxial catheter technology. TAIC were performed based on the blood supply and staining degree of the tumor. For the target vessel, by selective catheterization and DSA (Digital Subtraction Angiography), the vascular distribution and staining degree of the tumor can be directly observed.
Droga: FOLFOX (5-fluorouracil, Leucovorin, Oxaliplatin)
Patients in the TAIC group will undergo FOLFOX-based TAIC at weeks 0 and 4 and receive FOLFOX-based IVC at weeks 2 and 6. The FOLFOX-based TAIC consists of oxaliplatin (85 mg/m²) administered as a 2-hour transarterial infusion, leucovorin (400 mg/m²) administered as a 2-hour transarterial infusion, and fluorouracil (2400 mg/m²) administered as a 44-hour transarterial infusion. According to the results of the genetic mutation status, HER2-positive patients are administered trastuzumab in combination every cycle.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
The quality of life
Periodo de tiempo: From enrollment to the end of treatment at 10 weeks, 3 days before each administration period and within 2 weeks after the end of the treatment.
The quality of life was assessed using the EORTC QLQ-C30. The QLQ-C30 is composed of both multi-item scales and single-item measures. These include five functional scales, three symptom scales, a global health status / QoL scale, and six single items. Each of the multi-item scales includes a different set of items - no item occurs in more than one scale. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Thus a high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status /QoL represents a high QoL, but a high score for a symptom scale /item represents a high level of symptomatology / problems.
From enrollment to the end of treatment at 10 weeks, 3 days before each administration period and within 2 weeks after the end of the treatment.

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
DCR
Periodo de tiempo: The DCR is assessed at 4 and 8 weeks by the local investigator.
According to RECIST1.1, DCR (disease control rate) was defined as the sum of complete remission, partial response, and stable disease.
The DCR is assessed at 4 and 8 weeks by the local investigator.
ORR
Periodo de tiempo: ORR is defined as the percentage of patients with complete response (CR) and partial response (PR) according to Response Evaluation Criteria in Solid Tumor (RECIST) 1.1.The ORR is assessed at 4 and 8 weeks by the local investigator.
ORR is defined as the percentage of patients with complete response (CR) and partial response (PR) according to Response Evaluation Criteria in Solid Tumor (RECIST) 1.1.The ORR is assessed at 4 and 8 weeks by the local investigator.

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
The patients' dysphagia degree
Periodo de tiempo: From enrollment to the end of treatment at 10 weeks, 3 days before each administration period and within 2 weeks after the end of the treatment.
The patients' dysphagia degree was evaluated based on the Stooler Dysphagia Grading Scale . The Stooler Dysphagia Grading Scale (often referred to as the Stooler Classification) is a clinical assessment tool primarily used to evaluate the severity of dysphagia (swallowing difficulties), particularly in patients with esophageal cancer or other conditions causing progressive obstruction. It categorizes swallowing ability into five distinct levels based on the type of food the patient can tolerate. Grade 0 Normal Swallowing. Grade 1 Mild Dysphagia. Grade 2 Moderate Dysphagia. Grade 3 Severe Dysphagia. Grade 4 Complete Obstruction.
From enrollment to the end of treatment at 10 weeks, 3 days before each administration period and within 2 weeks after the end of the treatment.
The general condition of the patients
Periodo de tiempo: From enrollment to the end of treatment at 10 weeks, 3 days before each administration period and within 2 weeks after the end of the treatment.
The Eastern Cooperative Oncology Group (ECOG) performance status. ECOG 0-1: Patients generally have good functional status. ECOG 2: Patients have compromised functional status. ECOG ≥3: Patients are generally considered unfit for aggressive cytotoxic chemotherapy due to poor tolerance and increased risk of severe adverse events.
From enrollment to the end of treatment at 10 weeks, 3 days before each administration period and within 2 weeks after the end of the treatment.
OS
Periodo de tiempo: From enrollment until the date of death from any cause, assessed up to 100 months
Overall Survival (OS) was used as the outcome measure.
From enrollment until the date of death from any cause, assessed up to 100 months
Pathological response
Periodo de tiempo: Surgical resectability assessment should be performed within 2 weeks after the completion of the entire treatment cycle, and pathological response should be conducted if surgery is performed.
Pathological response was assessed using surgical specimens according to the Becker's tumor regression grade system
Surgical resectability assessment should be performed within 2 weeks after the completion of the entire treatment cycle, and pathological response should be conducted if surgery is performed.
The nutritional status
Periodo de tiempo: From enrollment to the end of treatment at 10 weeks, 3 days before each administration period and within 2 weeks after the end of the treatment.
The nutritional status was evaluated using the NRS-2002. NRS-2002 is a standardized tool designed to identify hospital patients who are at nutritional risk. Total Score ≥ 3: Indicates the presence of nutritional risk. Total Score < 3: Indicates no current nutritional risk.
From enrollment to the end of treatment at 10 weeks, 3 days before each administration period and within 2 weeks after the end of the treatment.
Adverse events
Periodo de tiempo: From enrollment to the end of treatment at 10 weeks, 3 days before each administration period and within 2 weeks after the end of the treatment.
Adverse events were classified according to the Common Terms Criteria for Adverse Events (V 6.0).
From enrollment to the end of treatment at 10 weeks, 3 days before each administration period and within 2 weeks after the end of the treatment.
Frailty
Periodo de tiempo: From enrollment to the end of treatment at 10 weeks, 3 days before each administration period and within 2 weeks after the end of the treatment.
CFS (clinical frailty scale) utilizes a 9-point scale. Level 1 (Very Fit) to Level 9 (Terminally Ill).
From enrollment to the end of treatment at 10 weeks, 3 days before each administration period and within 2 weeks after the end of the treatment.
Grip strength
Periodo de tiempo: From enrollment to the end of treatment at 10 weeks, 3 days before each administration period and within 2 weeks after the end of the treatment.
Hand grip strength is a convenient measure for both clinical practice. Grip strength is assessed using a digital hand dynamometer model. The patient should be comfortably seated with the elbow supported at an angle of 90 degrees to the body under the seated method. Grip strength was tested 3 consecutive times consisting of a grip duration of three seconds with a one-minute rest in between. Alternating bilateral assessment of hands should be performed with no warm-up tests. The measured grip value for each hand defined as the average value obtained from repeated measures. The kilogram (kg) is the only unit of measurement.
From enrollment to the end of treatment at 10 weeks, 3 days before each administration period and within 2 weeks after the end of the treatment.

Colaboradores e Investigadores

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

Patrocinador

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Investigadores

  • Director de estudio: Quanda Liu, PhD, Guanganmen 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)

1 de noviembre de 2025

Finalización primaria (Estimado)

1 de enero de 2028

Finalización del estudio (Estimado)

1 de diciembre de 2028

Fechas de registro del estudio

Enviado por primera vez

8 de mayo de 2026

Primero enviado que cumplió con los criterios de control de calidad

15 de junio de 2026

Publicado por primera vez (Actual)

17 de junio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

17 de junio de 2026

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

15 de junio de 2026

Última verificación

1 de abril de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 2025-276-KY

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Descripción del plan IPD

The investigators agree to allow the auditors/inspectors/monitors to have direct access to the trial records for review. The investigator will make every effort to help with the performance of the audits and inspections, giving access to all necessary facilities, data, and documents.

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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