A Study of Fruquintinib Plus Chemotherapy for Postoperative Treatment of HER2-Negative Gastric Cancer With Poor TRG
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorHenan Cancer Hospital
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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;
Trial design
Design model
Single group
Treatments tested in this trial
Fruquintinib
DrugFruquinitinib: 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
Treatment groups
69 Participants
are divided into 1 treatment groupGroup A: Experimental groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
3-year recurrence-free survival rate
Percentage of recurrence-free patients within 3 years of surgery
Time frame
Three years after surgerySecondary outcomes
1
Overall survival
From the start of treatment to the date of death from any cause
Time frame
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"2
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
Time frame
from the first drug administration to within 30 days for the last doseSponsors and contacts
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Source ClinicalTrials.gov