RecruitingPhase 2NCT06774222

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

A Phase II, Single-Arm, Single-Center Study of Fruquintinib Combined With Standard Chemotherapy for Postoperative Treatment of HER2-Negative Gastric Cancer Patients With Poor Tumor Regression Grade.


Sponsor

Henan Cancer Hospital

Enrollment

69 participants

Start Date

Sep 12, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding a drug called fruquintinib (a targeted therapy that blocks blood vessel growth in tumors) to standard chemotherapy helps prevent cancer from coming back in people with stomach or stomach-junction cancer that did not respond well to pre-surgery chemotherapy. 'Poor response' means the tumor did not shrink much during initial treatment. **You may be eligible if...** - You are between 18 and 75 years old - You have stomach or gastroesophageal junction cancer confirmed by biopsy - Your cancer did not respond well to pre-surgery chemotherapy (Tumor Regression Grade 2 or 3) - You had successful surgery to remove the cancer (R0 resection) - You are in good general health (ECOG 0–1) - Your expected survival is at least 2 years **You may NOT be eligible if...** - You have had previous stomach cancer surgery - You have HER2-positive cancer - You have other serious health conditions that prevent surgery or chemotherapy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGFruquintinib

Fruquinitinib: Take 4 mg QD for 2 weeks and stop for 1 week, every 3 weeks for a cycle; Standard chemotherapy: The selection of drugs is recommended by the 2024CSCO Guidelines for the Diagnosis and Treatment of Gastric Cancer, including SOX, XLOX or S-1, and the treatment cycle is one every 3 weeks


Locations(1)

Henan Cancer Hospital

Zhengzhou, China

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NCT06774222


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