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.

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.

Study Overview

• Status: Recruiting
• Conditions: Gastric/Gastroesophageal Junction Adenocarcinoma
• Intervention / Treatment: Drug: Fruquintinib

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 Type: Interventional
• Enrollment (Estimated): 69
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Fei Ma, M.D.; Phone Number: +8613703923592; Email: mafeizzu@outlook.com

Study Locations

• China
  • Zhengzhou, China
    • Recruiting
    • Henan Cancer Hospital
    • Contact: Fei Ma

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental group; Fruquintinib Combined with Standard Chemotherapy	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; Other Names: HMPL-013

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
3-year recurrence-free survival rate	Percentage of recurrence-free patients within 3 years of surgery	Three years after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival	From the start of treatment to the date of death from any cause	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	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	from the first drug administration to within 30 days for the last dose

Collaborators and Investigators

• Sponsor: Henan Cancer Hospital
• Investigators: Principal Investigator: Fei Ma, M.D., Working relationship

Study record dates

Study Major Dates

• Study Start (Actual): September 12, 2023
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: December 12, 2024
• First Submitted That Met QC Criteria: January 13, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 13, 2025
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Carcinoma; Adenocarcinoma
• Other Study ID Numbers: 2022-421

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No