NCT07334431 Fruquintinib Combined With Trastuzumab and XELOX as First-line Treatment in Patients With HER2-positive Advanced Gastric Cancer
| NCT ID | NCT07334431 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Henan Cancer Hospital |
| Condition | Gastric Adenocarcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 45 participants |
| Start Date | 2024-02-22 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 45 participants in total. It began in 2024-02-22 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * Have fully understood the study and voluntarily signed the informed consent; * 18-75 years old (including 18 and 75 years old); * Pathologically determined advanced gastric or gastroesophageal junction adenocarcinoma; * No previous anti-tumor treatment for metastatic diseases; * HER2 positive; * Eastern Cooperation Oncology Group (ECOG) performance status of 0-1; * Life expectancy ≥ 3 months; * At least one measurable lesion according to RECIST version 1.1; * The functions of vital organs met the following requirements (Blood components and cell growth factors were not allowed within 14 days before enrollment): * Absolute neutrophil count ≥1.5×109/L; * Platelet ≥100×109 /L; * Hemoglobin ≥90g/L; * Total bilirubin \< 1.5 ULN; * ALT and/or AST \< 1.5 ULN ; * Serum creatinine (Cr) \<1.5×ULN; * Endogenous creatinine clearance ≥50ml/min; * Female patients of childbearing age should take effective contraceptive measures; * Good compliance, cooperate with follow-up. Exclusion Criteria: * Failure to comply with the study protocol or study procedure; * Previous treatment with vascular endothelial growth factor receptor (VEGFR) inhibitors, chemotherapy or immune checkpoint inhibitors; * Have had other malignancies within the past 5 years, except basal cell or squamous cell carcinoma of the skin after radical surgery, or carcinoma in situ of the cervix; * Known presence of symptomatic central nervous system metastasis or brain metastases; * Had autoimmune disease or history of autoimmune disease within 4 weeks before enrollment; * Previously received allogeneic bone marrow transplantation or organ transplantation; * Uncontrolled malignant ascites (defined as ascites that cannot be controlled by diuretics or puncture as determined by the researcher); * Severe cardiovascular disease, including unstable angina pectoris or myocardial infarction, occurs within 6 months before the start of study treatment; * Subjects who are allergic to the investigational drug or any of its adjuncts; * Participated in other domestic unapproved or unmarketed drug clinical trials and accepted the corresponding experimental drug treatment within 4 weeks before enrollment; * International Standardized Ratio (INR) \>1.5 or partially activated prothrombin time (APTT) \>1.5×ULN; * The investigator identified clinically significant electrolyte abnormalities; * Hypertension that could not be controlled by drugs before enrollment was defined as: systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg; * Poorly controlled diabetes mellitus was present before enrollment (fasting glucose concentration ≥CTCAE level 2 after formal treatment); * Had any disease or condition prior to enrollment that affected drug absorption, or the patient could not take fruquintinib orally; * Gastrointestinal diseases such as active ulcer of stomach and duodenum, ulcerative colitis, or active bleeding of unresectosed tumors, or other conditions that may cause gastrointestinal bleeding or perforation as determined by researchers before enrollment; * Patients with evidence or history of significant bleeding tendency within 3 months prior to enrollment (bleeding within 3 months \>30 mL, hematemesis, stool, stool blood), hemoptysis (within 4 weeks \>5 mL of fresh blood) or had a thromboembolic event (including stroke events and/or transient ischemic attacks) within 12 months; * Clinically significant cardiovascular disease, including but not limited to acute myocardial infarction, severe/unstable angina pectoris, or coronary artery bypass grafting within 6 months prior to enrollment; New York Heart Association (NYHA) Grades for Congestive Heart Failure \>Level 2; Ventricular arrhythmias requiring medical treatment; LVEF (Left ventricular Ejection Fraction) \<50%; * Clinically significant cardiovascular disease, including but not limited to acute myocardial infarction, severe/unstable angina pectoris, or coronary artery bypass grafting within 6 months prior to enrollment; New York Heart Association (NYHA) Grades for Congestive Heart Failure \>Level 2; Ventricular arrhythmias requiring medical treatment; LVEF (Left ventricular Ejection Fraction) \>50%; * Unmitigated toxicity higher than CTCAE v5.0 grade 1 due to any previous anticancer therapy, excluding alopecia, lymphocytopenia, and oxaliplatin grade ≤2 neurotoxicity; * Women who are pregnant (positive pregnancy test before medication) or breastfeeding; * Received blood transfusion therapy, blood products and hematopoietic factors, such as albumin and granulocyte colony-stimulating factor (G-CSF), within 14 days before enrollment; * Any other medical condition, clinically significant metabolic abnormality, physical abnormality or laboratory abnormality, which, in the investigator's judgment, reasonably suspects that the patient has a medical condition or condition that is not suitable for the use of the investigational drug (such as having seizures and requiring treatment), or which would affect the interpretation of the study results or place the patient at high risk； * Urine routine indicated urinary protein ≥2+, and 24-hour urinary protein volume \> 1.0g; * Complications require long-term treatment with immunosuppressants or systemic or local use of immunosuppressive corticosteroids (\> 10mg/ day prednisone or other therapeutic hormone); * Investigators believe that the patient has any other conditions that are not suitable for participating in the study.
Contact & Investigator
Huifang Lv
PRINCIPAL INVESTIGATOR
Henan Cancer Hospital (Affiliated Cancer Hospital of Zhengzhou University)
Frequently Asked Questions
Who can join the NCT07334431 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Gastric Adenocarcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07334431 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07334431 currently recruiting?
Yes, NCT07334431 is actively recruiting participants. Contact the research team at zlyylvhf1859@zzu.edu.cn for enrollment information.
Where is the NCT07334431 trial being conducted?
This trial is being conducted at Zhengzhou, China.
Who is sponsoring the NCT07334431 clinical trial?
NCT07334431 is sponsored by Henan Cancer Hospital. The principal investigator is Huifang Lv at Henan Cancer Hospital (Affiliated Cancer Hospital of Zhengzhou University). The trial plans to enroll 45 participants.