NCT07552402招募中不适用
Paclitaxel Oral Solution Plus Fruquintinib Versus Investigator's Choice as Second-Line Treatment for Advanced Gastric Cancer: A Multicenter, Open-Label, Randomized Controlled Trial
Harbin Medical University6 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2026年6月10日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 6
- 主要终点
- Progression-free survival（PFS）
研究概览
简要总结
The goal of this study is to evaluate the efficacy and safety of oral paclitaxel solution plus fruquintinib as second-line therapy in adult subjects with advanced or metastatic gastric (G) or gastroesophageal junction (GEJ) cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Age 18 to 75 years, regardless of sex;
- •Histologically and/or cytologically confirmed advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma that has failed first-line therapy or developed intolerable toxicity to first-line treatment.
- •Presence of at least one measurable lesion per RECIST v1.1 criteria (Note: Previously irradiated lesions cannot be used as target lesions unless unequivocal progression of the lesion after radiotherapy is documented);
- •Body weight ≥40 kg or BMI >18.5 kg/m²;
- •No severe hematologic, hepatic, or renal abnormalities:
- •Hematology: Absolute neutrophil count (ANC) ≥1.5×10⁹/L; Platelet count (PLT) ≥100×10⁹/L; Hemoglobin (Hb) ≥90 g/L;
- •Chemistry: Total bilirubin (TBIL) ≤1.5× upper limit of normal (ULN); ALT and AST ≤2.5×ULN in the absence of liver metastases, or ≤5×ULN if liver metastases are present; Serum creatinine (Cr) ≤1.5×ULN;
- •Urinalysis: Urine protein ≤1+; If urine protein is ≥2+, a 24-hour urine protein test must be performed, and enrollment is permitted only if the 24-hour urine protein is <1.0 g;
- •ECOG Performance Status (PS) 0-1;
- •Life expectancy ≥12 weeks;
- •Signed informed consent.
排除标准
- •Known HER2-positive status without prior anti-HER2 therapy (patients who progressed after anti-HER2 therapy are eligible);
- •History of another primary malignancy within 3 years prior to the first study drug administration, except for adequately treated basal cell or squamous cell carcinoma of the skin, or in situ carcinomas of the cervix, breast, or other sites;
- •Receipt of radiotherapy (except palliative radiotherapy), chemotherapy, or small-molecule targeted anticancer therapy within 4 weeks or within 5 half-lives of the agent (whichever is shorter) prior to the first dose of study drug. Patients who discontinued other investigational agents for more than 5 half-lives are eligible for screening. Additionally, treatment with large-molecule targeted anticancer agents within 4 weeks prior to the first study drug dose is prohibited;
- •Toxicity from prior anticancer therapy not recovered to ≤ Grade 1 or baseline levels (except alopecia; neurotoxicity must have resolved to ≤ Grade 2) within 2 weeks prior to the first study drug administration;
- •Presence of dysphagia, uncontrolled nausea, vomiting, diarrhea, or known malabsorption syndrome that may interfere with oral drug absorption;
- •Active gastrointestinal conditions such as gastric/duodenal ulcer, ulcerative colitis, or bowel obstruction, or any other condition deemed by the investigator to carry a risk of gastrointestinal hemorrhage or perforation; history of gastrointestinal perforation or fistula within the past 6 months; or incomplete recovery from surgery related to gastrointestinal perforation or fistula;
- •Evidence of significant bleeding or history of bleeding (e.g., hematemesis, hemoptysis) within 2 months prior to randomization. Patients with melena and positive fecal occult blood test must undergo gastroenteroscopy to rule out active bleeding or active ulcer before enrollment;
- •Requirement for long-term use of proton pump inhibitors (PPIs) or H2-receptor antagonists during the trial; or use of strong inducers or inhibitors of cytochrome P450 (CYP) 3A4 or CYP2C8 within 2 weeks prior to the first study drug dose;
- •Known active central nervous system (CNS) metastases and/or leptomeningeal carcinomatosis;
- •Active infections or serious infectious diseases, including but not limited to: HIV infection (positive HIV antibody), active hepatitis (active HCV infection defined as positive HCV RNA; HCV antibody-positive but RNA-negative patients are allowed), active HBV infection (HBsAg-positive with HBV DNA >2000 IU/mL), bacteremia, severe pneumonia requiring systemic therapy, or active tuberculosis;
- •Any of the following cardiovascular conditions: myocardial infarction, unstable angina, congestive heart failure (New York Heart Association Class ≥2), or other clinically significant cardiac disease within 6 months prior to the first study drug dose; clinically significant ECG abnormalities (e.g., arrhythmias, QTc interval >450 ms); left ventricular ejection fraction (LVEF) <50% on echocardiography; or uncontrolled hypertension despite treatment with ≥2 antihypertensive agents (systolic BP >140 mmHg or diastolic BP >90 mmHg);
- •Prior systemic therapy targeting VEGF or VEGFR; or prior treatment with paclitaxel, docetaxel, nab-paclitaxel, liposomal paclitaxel, or polymeric micelle paclitaxel;
- •Known hypersensitivity to any component of the investigational product;
- •Pregnant or lactating women;
- •Uncontrolled symptomatic pleural, peritoneal, or pericardial effusion requiring repeated drainage. Asymptomatic patients with minimal effusions detected only on imaging and who have not received drainage or other intervention within 2 weeks prior to enrollment are eligible;
- •Major surgery (e.g., craniotomy, thoracotomy, or laparotomy) within 4 weeks prior to first dosing, or presence of non-healed surgical wounds, ulcers, or fractures. Patients may be enrolled if the investigator determines they are fit to receive study drug ≥2 weeks post-surgery;
- •History of deep vein thrombosis, pulmonary embolism, or other significant thromboembolic events within 3 months prior to study entry; ongoing anticoagulation therapy with warfarin, low-molecular-weight heparin, or similar agents. Prophylactic low-dose anticoagulation is permitted if INR ≤1.5 per inclusion criteria;
- •Chronic use of nonsteroidal anti-inflammatory drugs (e.g., indomethacin, ibuprofen) or antiplatelet agents (e.g., clopidogrel, ticlopidine, dipyridamole). Low-dose aspirin (≤325 mg/day) is allowed;
- •Any other condition deemed by the investigator as unsuitable for participation in this study.
研究组 & 干预措施
Oral Paclitaxel Solution Plus Fruquintinib
Experimental
Oral paclitaxel solution: 200mg/m2, p.o., bid, on days 1, 8, and 15 of each 28-day cycle.
Fruquintinib: 4 mg orally once daily, 3 weeks on/1week off
干预措施: Oral Paclitaxel Solution Plus Fruquintinib (Drug)
Investigator-Selected Chemotherapy
Active Comparator
Investigator-selected chemotherapy includes injectable taxanes (paclitaxel injection, albumin-bound paclitaxel, docetaxel, etc.), irinotecan, etc., excluding oral paclitaxel solution. Regimens and doses shall be determined by the investigator in accordance with recommendations from current clinical guidelines.
干预措施: Investigator Choice (IC) Chemotherapy (Drug)
结局指标
主要结局
Progression-free survival（PFS）
时间窗: assessed up to 1 year
Progression-free survival (PFS) is defined as the time from the date of randomization to disease progression per RECIST 1.1 or death due to any cause, whichever occurs first.
次要结局
- Objective response rate（ORR）(assessed up to 1 year)
- Disease Control Rate（DCR）(assessed up to 1 year)
- Overall survival（OS）(From randomization until death due to any cause, up to 3 years.)
- Adverse event(From first dose to 30 days post the last dose)
- Qualtiy of life assesd by EORTC QLQ-C30 v3.0(Evaluation from baseline to the 30 days post the last dose)
研究者
Yanqiao Zhang
Professor
The Second Affiliated Hospital of Harbin Medical University
研究点 (6)
Loading locations...
相似试验
招募中
1 期
Fruquintinib Combined With Trastuzumab and XELOX as First-line Treatment in Patients With HER2-positive Advanced Gastric CancerNCT07334431Henan Cancer Hospital45
招募中
2 期
Phase II Study of Weekly Paclitaxel/Nab-Paclitaxel, Pembrolizumab, and Mirabegron for Recurrent Ovarian CancerOvarian CancerNCT07261683Obstetrics & Gynecology Hospital of Fudan University20
招募中
2 期
QL1706 Plus Lenvatinib in Previously Treated Penile CancerPenile CancerNCT07384416Sun Yat-sen University47
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
尚未招募
3 期
Fruquintinib Versus Bevacizumab Plus Chemotherapy in Second-Line RAS-Mutant Metastatic Colorectal Cancer (FRU-RAS)Colorectal CancerNCT07362836Fudan University224