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

Recruiting now · Phase 2

Conditions studied: Gastric/Gastroesophageal Junction Adenocarcinoma

In brief

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.

Key facts

Study ID

NCT06774222

Run by

Henan Cancer Hospital

People needed

69

Starts

2023-09-12

Expected to finish

2026-12-31

Last updated by the study team

2025-01-14

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Henan Cancer Hospital — Zhengzhou, China (enrolling)

Full record on ClinicalTrials.gov

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