Panoramica

Idoneità

Dettagli del Disegno

Bracci e Interventi

Misure di Esito

Siti dello Studio

Fonte: NCT06774222

Reclutamento in corso

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

Interventistico

Fase 2

Henan Cancer Hospital

Sponsor: Henan Cancer Hospital

Ultimo Aggiornamento: 25 marzo 2025
Avviso - Le informazioni provengono da registri pubblici e potrebbero non riflettere i cambiamenti in tempo reale presso il centro locale.

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.

Mostra Descrizione Dettagliata

Categoria di Trattamento

Terapia Mirata

Mutazioni richieste

Nessuno

Studio Iniziato

12 settembre 2023

Ultimo Aggiornamento dello Sponsor

25 marzo 2025

Completamento Stimato

31 dicembre 2025

Contatto dello studio

Nome:Fei Ma, M.D.

Email:mafeizzu@outlook.com

Telefono:+8613703923592

Idoneità

Criteri di Inclusione

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.

Criteri di Esclusione

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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Dettagli del Disegno

AllocazioneN/A

Modello di InterventoSingle Group Assignment

MascheramentoNone (Open Label)

Numero da Arruolare69

Bracci e Interventi

Bracci

Interventi

Tipo: Experimental

Descrizione: Fruquintinib Combined with Standard Chemotherapy

Interventi:

Fruquintinib

Misure di Esito

Misure di Esito Primarie

3-year recurrence-free survival rateThree years after surgery

Percentage of recurrence-free patients within 3 years of surgery

Misure di Esito Secondarie

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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Siti dello Studio

Questo studio ha 1 sito

Henan Cancer Hospital

Zhengzhou, CN

Nome:Fei Ma

In fase di reclutamento

Zhengzhou, CN

Henan Cancer Hospital

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