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

NCT07334431 | Recruiting Phase 1 DMC

• 1 other identifier: 2023-134-001
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastric Adenocarcinoma; Gastric (Stomach) Cancer; GEJ Adenocarcinoma; First-line Therapy; Fruquintinib; HER2-positive Gastric Cancer

Outcome Measures

Primary Outcomes (2)

• Recommended Phase 2 doses (RP2Ds)

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

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

• 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.

  Up to 3 years

Secondary Outcomes (3)

• OS

  Up to 3 years

• ORR

  Up to 3 years

• DCR

  Up to 3 years

Other Outcomes (1)

• Exploratory endpoints

  Up to 3 years

Study Arms (1)

fruquintinib＋trastuzumab + XELOX

EXPERIMENTAL

Drug: fruquintinib＋trastuzumab + XELOX

Interventions

fruquintinib＋trastuzumab + XELOX DRUG

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.

fruquintinib＋trastuzumab + XELOX

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have fully understood the study and voluntarily signed the informed consent;
• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Henan Cancer Hospital: lead

Study Sites (1)

Henan Cancer Hospital (Affiliated Cancer Hospital of Zhengzhou University)

Zhengzhou, Henan, 210000, China

RECRUITING

Related Links

• Related Info

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

XELOX

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Officials

• Huifang Lv

  Henan Cancer Hospital (Affiliated Cancer Hospital of Zhengzhou University)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Huifang Lv

CONTACT

8618639027635; zlyylvhf1859@zzu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2025
• First Posted: January 12, 2026
• Study Start: February 22, 2024
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 12, 2026

Record last verified: 2025-03

Locations

CN (1)