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

Phase 2

Recruiting

• Conditions: Gastric/Gastroesophageal Junction Adenocarcinoma
• Interventions: Drug: Fruquintinib

• Registration Number: NCT06774222
• Lead Sponsor: Henan Cancer Hospital

Brief 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.

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 .

Study Timeline

• Study Start: 2023-09-12
• Status Verified: 2024-11
• Study First Submitted: 2024-12-12
• Study First Submitted QC: 2025-01-13
• Last Update Submitted: 2025-01-13
• Study First Posted: 2025-01-14
• Last Update Posted: 2025-01-14
• Primary Completion: 2025-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 69

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental group	Fruquintinib	Fruquintinib Combined with Standard Chemotherapy

Primary Outcome Measures

Name	Time	Method
3-year recurrence-free survival rate	Three years after surgery	Percentage of recurrence-free patients within 3 years of surgery

Secondary Outcome Measures

Name	Time	Method
Overall survival	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"	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 v5.0	from 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

Trial Locations

Locations (1)

Henan Cancer Hospital; 🇨🇳 Zhengzhou, China