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Gastric AdenocarcinomaPhase 1/2NCT07334431

Fruquintinib Combined With Trastuzumab and XELOX as First-line Treatment in Patients With HER2-positive Advanced Gastric Cancer

A Phase 1/2 study testing fruquintinib＋trastuzumab + XELOX in people with Gastric Adenocarcinoma and Gastric (Stomach) Cancer, run by Henan Cancer Hospital at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
fruquintinib＋trastuzumab + XELOX
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
45 participants
Where
1 siteChina
Study dates
22 Feb 2024to 31 Dec 2026
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;
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  • 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.

Who cannot join

  • 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;
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  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Huifang Lv contact

8618639027635

zlyylvhf1859@zzu.edu.cn

China1 site, 1 recruiting

  • Henan Cancer Hospital (Affiliated Cancer Hospital of Zhengzhou University)

    Zhengzhou, Henan, 210000

    Huifang Lv, 18639027635, zlyylvhf1859@zzu.edu.cn

    Huifang Lv

    Recruiting

Other trials in China

About this study

Official title: 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

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.

Being tested
fruquintinib＋trastuzumab + XELOX
Medical subject headings
Stomach Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • fruquintinib＋trastuzumab + XELOXDrug

    phase Ib: fruquintinib (3+3 dose escalation design): L1: 2 mg/d, L2: 3 mg/d, L3: 4 mg/d, qd po, D1-14, Q3W; XELOX regimen: Oxaliplatin: 130mg/m2, ivgtt 2h, D1, Q3W; Capecitabine: 1000 mg/m2, bid, D1-D14, Q3W; trastuzumab: 8 mg/kg loading dose and then 6 mg/kg maintenance dose, IV, D1, Q3W; phase II: fruquintinib: RP2D; XELOX regimen: Oxaliplatin: 130mg/m2, ivgtt 2h, D1, Q3W; Capecitabine: 1000 mg/m2, bid, D1-D14, Q3W; trastuzumab: 8 mg/kg loading dose and then 6 mg/kg maintenance dose, IV, D1, Q3W. After 6-8 cycles of combination therapy, trastuzumab plus fruquintinib plus capecitabine was given as maintenance therapy until disease progression, death or intolerable toxicity.

Study groups in NCT07334431
Study groupRoleWhat they receive
fruquintinib＋trastuzumab + XELOXExperimentalNot described
Receives: Drug: fruquintinib＋trastuzumab + XELOX

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Recommended Phase 2 doses (RP2Ds)

    To determine the recommended phase 2 dose of fruquintinib, according to the dose limiting toxicities (DLTs).

    Measured: When the first cycle of treatment is completed（approximately 21 days）

  2. PFS

    PFS was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first.

    Measured: Up to 3 years

Secondary outcomes (3)

  1. OS

    OS is defined as the time from the date of randomization to the date of death due to any cause.

    Measured: Up to 3 years

  2. ORR

    ORR is defined as the percentage of patients with a best overall response of complete response (CR) or partial response (PR) per RESISTv1.1.

    Measured: Up to 3 years

  3. DCR

    DCR is defined as the percentage of patients with a best overall response of confirmed complete or partial response, or stable disease (CR+ PR + SD) per RESISTv1.1.

    Measured: Up to 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jan 2026
  2. Study start22 Feb 2024
  3. Primary completion31 Dec 2025 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
45 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07334431
Sponsor's protocol ID
2023-134-001
Status last verified
Mar 2025
First submitted
11 Apr 2025
Last updated
12 Jan 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing fruquintinib＋trastuzumab + XELOX in people with Gastric Adenocarcinoma and Gastric (Stomach) Cancer, run by Henan Cancer Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 12 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Huifang Lv (8618639027635, zlyylvhf1859@zzu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recommended Phase 2 doses (RP2Ds) (time frame: When the first cycle of treatment is completed（approximately 21 days）). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07334431.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2026.

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