Fruquintinib Combined With Trastuzumab and XELOX as First-line Treatment in Patients With HER2-po… (NCT07334431) | Clinical Trial Compass
RecruitingPhase 1/2
Fruquintinib Combined With Trastuzumab and XELOX as First-line Treatment in Patients With HER2-positive Advanced Gastric Cancer
China45 participantsStarted 2024-02-22
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexALL
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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 aut…
What they're measuring
1
Recommended Phase 2 doses (RP2Ds)
Timeframe: When the first cycle of treatment is completed(approximately 21 days)