Resumen

Elegibilidad

Detalles del diseño

Brazos e Intervenciones

Medidas de resultado

Sitios del ensayo

Fuente: NCT06774222

Reclutando

A Study of Fruquintinib Plus Chemotherapy for Postoperative Treatment of HER2-Negative Gastric Cancer With Poor TRG

Intervencionista

Fase 2

Henan Cancer Hospital

Patrocinador: Henan Cancer Hospital

Última actualización: 25 de marzo de 2025
Aviso: La información proviene de registros públicos y puede no reflejar cambios en tiempo real en el centro local.

Given that a significant proportion of locally advanced gastric cancer patients still die from tumor recurrence after surgery, with long-term therapeutic outcomes stagnating and difficult to further improve, especially for patients with poor tumor regression grade (TRG) after surgery, this study aims to explore a new model of adjuvant therapy by conducting research on the use of Fruquintinib in combination with standard chemotherapy for postoperative treatment of HER2-negative gastric cancer patients with poor TRG, in order to bring greater survival benefits to patients.

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Categoría de tratamiento

Terapia dirigida

Erforderliche Mutationen

Ninguna

Ensayo iniciado

12 de septiembre de 2023

Última actualización por el patrocinador

25 de marzo de 2025

Finalización estimada

31 de diciembre de 2025

Contacto del estudio

Nombre:Fei Ma, M.D.

Correo electrónico:mafeizzu@outlook.com

Teléfono:+8613703923592

Elegibilidad

Criterios de inclusión

1. Fully understand the study and voluntarily sign the informed consent form;

2. Age between 18 and 75 years;

3. Histologically confirmed resectable or potentially resectable locally advanced gastric/gastroesophageal junction adenocarcinoma;

4. Tumor Regression Grade (TRG) 2 or 3 after preoperative adjuvant therapy;

5. R0 resection after neoadjuvant chemotherapy;

6. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;

7. Life expectancy of at least 2 years;

8. No prior anti-cancer treatment received;

9. Good compliance and cooperation with follow-up.

Criterios de exclusión

1. Inability to comply with the study protocol or procedures;

2. History of prior gastric cancer surgery;

3. Contraindications to surgical treatment and chemotherapy or physical condition and organ function that do not allow for major abdominal surgery;

4. Distant metastasis to organs other than the liver, such as lung, brain, and bone;

5. Known HER2-positive patients;

6. Uncontrolled hypertension despite medication prior to enrollment;

7. Poorly controlled diabetes despite medication prior to enrollment;

8. Urine routine indicating proteinuria ≥2+, and a 24-hour urine protein quantification >1.0g;

9. Presence of conditions requiring intervention such as bleeding, perforation, or obstruction prior to enrollment;

10. Patients deemed ineligible for this study by the investigator.

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Detalles del diseño

AsignaciónN/A

Modelo de intervenciónSingle Group Assignment

EnmascaramientoNone (Open Label)

Número a inscribir69

Brazos e Intervenciones

Brazos

Intervenciones

Tipo: Experimental

Descripción: Fruquintinib Combined with Standard Chemotherapy

Intervenciones:

Fruquintinib

Medidas de resultado

Medidas de resultado primarias

3-year recurrence-free survival rateThree years after surgery

Percentage of recurrence-free patients within 3 years of surgery

Medidas de resultado secundarias

Overall survivalOS is the time interval from the start of treatment to death due to any reason or lost of follow-up，whichever came first, assessed up to 3 years"

From the start of treatment to the date of death from any cause

AEs-Number of participants with treatment-related adverse events as assessed by CTCAE v5.0from the first drug administration to within 30 days for the last dose

Patients' blood and non-blood abnormal values or conditions were collected according to the frequency of visits per cycle and recorded for evaluation using CTCAE5.0 criteria

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Sitios del ensayo

Este estudio tiene 1 sitio de ensayo

Henan Cancer Hospital

Zhengzhou, CN

Nombre:Fei Ma

Reclutando

Zhengzhou, CN

Henan Cancer Hospital

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