Actively Recruiting
Fruquintinib Combined With Trastuzumab and XELOX as First-line Treatment in Patients With HER2-positive Advanced Gastric or Gastroesophageal Junction Adenocarcinoma: an Open-label, Single-arm, Single-center Phase Ib/II Clinical Study
Led by Henan Cancer Hospital · Updated on 2026-01-12
45
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of combining fruquintinib with trastuzumab and XELOX chemotherapy as a first treatment for patients with HER2-positive advanced gastric or gastroesophageal junction adenocarcinoma. This open-label, single-center study includes patients aged 18 to 75 years with no previous treatment for metastatic disease, aiming to find the recommended doses and measure progression-free survival. Participants receive fruquintinib in escalating doses during phase Ib, along with a XELOX regimen consisting of oxaliplatin and capecitabine, plus trastuzumab given intravenously every three weeks. After 6-8 cycles of this combination, patients continue on maintenance therapy with trastuzumab, fruquintinib, and capecitabine until disease progression, death, or intolerable side effects. Throughout the study, patients will have regular assessments including tumor measurements to monitor response, safety evaluations, and laboratory tests. The primary outcomes include determining the recommended phase 2 doses after the first treatment cycle and progression-free survival over up to three years. Secondary outcomes like overall survival and tumor response rates will also be tracked. The total involvement may last up to three years with ongoing monitoring.
CONDITIONS
Brief 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...
- Fully understand the study and voluntarily sign the informed consent
- Aged between 18 and 75 years old (inclusive)
- Diagnosed with advanced gastric or gastroesophageal junction adenocarcinoma
- No prior anti-tumor treatment for metastatic disease
- HER2 positive status
- Eastern Cooperation Oncology Group (ECOG) performance status of 0 or 1
- Life expectancy of at least 3 months
- At least one measurable lesion according to RECIST version 1.1
- Vital organ function within specified limits including blood counts, liver and kidney function
- 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
- Other malignancies within the past 5 years except certain skin or cervical cancers
- Symptomatic central nervous system or brain metastases
- Autoimmune disease within 4 weeks before enrollment
- Previous allogeneic bone marrow or organ transplantation
- Uncontrolled malignant ascites
- Severe cardiovascular disease within 6 months before study
- Allergy to investigational drug or its components
- Participation in other unapproved drug trials within 4 weeks before enrollment
- Elevated INR or APTT levels above specified limits
- Significant electrolyte abnormalities
- Uncontrolled hypertension before enrollment
- Poorly controlled diabetes mellitus
- Conditions affecting drug absorption or inability to take oral medication
- Active gastrointestinal diseases or bleeding risk
- Significant bleeding events or thromboembolic events within specified periods
- Clinically significant cardiovascular diseases including heart failure or arrhythmias
- Unresolved toxicity from previous cancer therapy above grade 1 except certain exceptions
- Pregnant or breastfeeding women
- Recent blood transfusions or hematopoietic factor treatments within 14 days
- Other medical conditions judged unsuitable by investigator
- Significant urinary protein abnormalities
- Need for long-term immunosuppressant or corticosteroid treatment
- Any other condition deemed unsuitable for participation by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 to 8 cycles of combination therapy, each cycle approximately 3 weeks
Participants receive a combination of fruquintinib, trastuzumab, and XELOX chemotherapy as first-line treatment for HER2-positive advanced gastric or gastroesophageal junction adenocarcinoma.
Visits every 3 weeks for treatment administration
Duration - Until disease progression, death, or intolerable toxicity
After initial combination therapy, participants continue maintenance therapy with trastuzumab, fruquintinib, and capecitabine until disease progression, death, or intolerable toxicity.
Regular visits for ongoing treatment and monitoring
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
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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