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Recruiting NCT06774222

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

Phase II Interventional Gastric/Gastroesophageal Junction Adenocarcinoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Fruquintinib.
Who it may be relevant to
Registry conditions: Gastric/Gastroesophageal Junction Adenocarcinoma. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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.

Overview

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.

Detailed description

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. The primary endpoint of this study is to evaluate the recurrence-free survival (RFS) in patients with poor TRG after neoadjuvant chemotherapy for gastric cancer who receive adjuvant therapy with Fruquintinib combined with standard chemotherapy postoperatively. Secondary endpoints include overall survival (OS) and safety .

Interventions

  • Drug Fruquintinib
    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

Primary outcome measures

  • 3-year recurrence-free survival rate [Time frame: Three years after surgery]
Secondary outcome measures (2)
  • Overall survival [Time frame: OS 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"]
  • AEs-Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 [Time frame: from the first drug administration to within 30 days for the last dose]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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 ≥2+, 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Henan Cancer Hospital — Zhengzhou

Identifiers

NCT: NCT06774222 · 2022-421

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗