Actively Recruiting

Phase 2
Age: 18Years - 75Years
All Genders
NCT06774222

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

Led by Henan Cancer Hospital · Updated on 2025-01-14

69

Participants Needed

1

Research Sites

172 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Fully understand the study and voluntarily sign the informed consent form
  • Age between 18 and 75 years
  • Histologically confirmed resectable or potentially resectable locally advanced gastric/gastroesophageal junction adenocarcinoma
  • Tumor Regression Grade (TRG) 2 or 3 after preoperative adjuvant therapy
  • R0 resection after neoadjuvant chemotherapy
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
  • Life expectancy of at least 2 years
  • No prior anti-cancer treatment received
  • Good compliance and cooperation with follow-up
Not Eligible

You will not qualify if you...

  • Inability to comply with the study protocol or procedures
  • History of prior gastric cancer surgery
  • Contraindications to surgical treatment and chemotherapy or physical condition and organ function that do not allow for major abdominal surgery
  • Distant metastasis to organs other than the liver, such as lung, brain, and bone
  • Known HER2-positive patients
  • Uncontrolled hypertension despite medication prior to enrollment
  • Poorly controlled diabetes despite medication prior to enrollment
  • Urine routine indicating proteinuria 652+, and a 24-hour urine protein quantification >1.0g
  • Presence of conditions requiring intervention such as bleeding, perforation, or obstruction prior to enrollment
  • Patients deemed ineligible for this study by the investigator

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Henan Cancer Hospital

Zhengzhou, China

Actively Recruiting

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Research Team

F

Fei Ma, M.D.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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