Actively Recruiting
Study of Fruquintinib Combined with Chemotherapy for Postoperative HER2-Negative Gastric Cancer Patients With Poor Tumor Regression Grade
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
Researchers are evaluating a new postoperative treatment approach for patients with locally advanced HER2-negative gastric or gastroesophageal junction adenocarcinoma who have a poor tumor regression grade (TRG) after preoperative therapy. This Phase II study aims to improve long-term survival, as many patients still face tumor recurrence despite surgery and current therapies. The trial focuses on combining Fruquintinib with standard chemotherapy to potentially bring better outcomes for these patients. Participants will receive Fruquintinib orally at a dose of 4 mg once daily for two weeks, followed by one week off, in a repeating three-week cycle. They will also receive standard chemotherapy regimens recommended by the 2024 CSCO Guidelines, such as SOX, XLOX, or S-1, administered every three weeks. This combination treatment is given after surgery in a single-arm study conducted at one center. During the study, patients will be closely monitored for recurrence-free survival over three years after surgery, which is the primary goal of the trial. Researchers will also assess overall survival and safety of the treatment. Participants are expected to cooperate with follow-up visits and evaluations to track their health status and treatment effects throughout the study period.
CONDITIONS
Official Title
A Study of Fruquintinib Plus Chemotherapy for Postoperative Treatment of HER2-Negative Gastric Cancer With Poor TRG
Who Can Participate
Eligibility Criteria
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
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
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Trial Site Locations
Total: 1 location
1
Henan Cancer Hospital
Zhengzhou, China
Actively Recruiting
Research Team
F
Fei Ma, M.D.
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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