Actively Recruiting
Fruquintinib Combined With Trastuzumab and XELOX as First-line Treatment in Patients With HER2-positive Advanced Gastric Cancer
Led by Henan Cancer Hospital · Updated on 2026-01-12
45
Participants Needed
1
Research Sites
149 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study was designed to evaluate the safety and efficacy of fruquintinib plus trastuzumab, and XELOX as first-line treatment for HER2-positive advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma.
CONDITIONS
Official Title
Fruquintinib Combined With Trastuzumab and XELOX as First-line Treatment in Patients With HER2-positive Advanced Gastric Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily signed informed consent
- Aged between 18 and 75 years inclusive
- Diagnosed with advanced gastric or gastroesophageal junction adenocarcinoma confirmed by pathology
- No previous anti-tumor treatment for metastatic disease
- HER2 positive status
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Life expectancy of at least 3 months
- At least one measurable tumor lesion based on RECIST version 1.1
- Adequate vital organ function as defined by: absolute neutrophil count 1.5 x 10^9/L; platelet count 100 x 10^9/L; hemoglobin 90 g/L; total bilirubin less than 1.5 times upper limit of normal (ULN); ALT and/or AST less than 1.5 times ULN; serum creatinine less than 1.5 times ULN; endogenous creatinine clearance 50 ml/min
- Female patients of childbearing potential must use effective contraception
- Good compliance and willingness to cooperate with follow-up
You will not qualify if you...
- Failure to comply with study protocol or procedures
- Previous treatment with VEGFR inhibitors, chemotherapy, or immune checkpoint inhibitors
- History of other malignancies within 5 years except certain skin or cervical cancers
- Known symptomatic central nervous system or brain metastases
- Autoimmune disease or history within 4 weeks before enrollment
- Prior allogeneic bone marrow or organ transplantation
- Uncontrolled malignant ascites
- Severe cardiovascular disease including unstable angina or myocardial infarction within 6 months
- Allergy to the investigational drug or its components
- Participation in other unapproved clinical trials within 4 weeks before enrollment
- Abnormal coagulation tests (INR >1.5 or APTT >1.5 times ULN)
- Clinically significant electrolyte abnormalities
- Uncontrolled hypertension (systolic 140 mmHg or diastolic 90 mmHg)
- Poorly controlled diabetes mellitus
- Conditions affecting drug absorption or inability to take fruquintinib orally
- Active gastrointestinal diseases causing bleeding or perforation
- Significant bleeding or thromboembolic events within specified recent periods
- Clinically significant cardiovascular disease or low heart function
- Unresolved toxicities from prior cancer therapies above grade 1 (excluding some exceptions)
- Pregnant or breastfeeding women
- Recent blood transfusions or use of hematopoietic factors within 14 days
- Other medical conditions or abnormalities judged by investigators to make participation unsafe
- Urinary protein abnormalities
- Long-term immunosuppressant or corticosteroid use
- Any other conditions deemed unsuitable for study participation by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Henan Cancer Hospital (Affiliated Cancer Hospital of Zhengzhou University)
Zhengzhou, Henan, China, 210000
Actively Recruiting
Research Team
H
Huifang Lv
CONTACT
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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