NCT07334431招募中1 期
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
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Recommended Phase 2 doses (RP2Ds)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
fruquintinib＋trastuzumab + XELOX
Experimental
干预措施: fruquintinib＋trastuzumab + XELOX (Drug)
结局指标
主要结局
Recommended Phase 2 doses (RP2Ds)
时间窗: When the first cycle of treatment is completed（approximately 21 days）
To determine the recommended phase 2 dose of fruquintinib, according to the dose limiting toxicities (DLTs).
PFS
时间窗: Up to 3 years
PFS was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first.
次要结局
- OS(Up to 3 years)
- ORR(Up to 3 years)
- DCR(Up to 3 years)
研究者
研究点 (1)
Loading locations...
相似试验
尚未招募
2 期
Trifluridine/Tipiracil Plus Fruquintinib vs. Trifluridine/Tipiracil Plus Bevacizumab in Refractory Metastatic Colorectal Cancer: A Randomized, Controlled, Open-Label, Non-Inferiority TrialNCT07261709Sun Yat-sen University236
招募中
4 期
Zanubrutinib Combined With Rituximab in the Treatment of Secondary HLH in B-cell LymphomaHemophagocytic LymphohistiocytosisNCT07270835The First Affiliated Hospital of Soochow University40
招募中
2 期
Multicenter, open-label, phase II study in patients with immunoglobulin M monoclonal gammopathy of unknown significance and Myelin Associated Glycoprotein antibodies related polyneuropathy and Zanubrutinib Treatment2023-505933-29-00University Medical Center Utrecht42
招募中
2 期
ELVN-002 combined with trastuzumab +/- chemotherapy in HER2 + Solid Tumors2023-509716-29-00Enliven Therapeutics Inc.156
招募中
1 期
Trastuzumab Deruxtecan, and pembrolizumab in participants with Locally Advanced/Metastatic Breast or Non-Small Cell Lung Cancer2023-509866-39-00Daiichi Sankyo Inc.76