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.
Henan Cancer Hospital
69 participants
Sep 12, 2023
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria9
- 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 Criteria10
- 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.
Interventions
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
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06774222