A Single-arm, Single-center Phase II Clinical Study on the Clinical Efficacy and Safety of Paclitaxel Polymeric Micelles for Injection Combined With Fruquintinib Capsules in the Second-line Treatment of Patients With Advanced Gastric Cancer
Overview
- Phase
- Phase 2
- Intervention
- Paclitaxel Polymeric Micelles for Injection combined with Fruquintinib Capsules
- Conditions
- Advanced Gastric Cancer
- Sponsor
- Shanghai Zhongshan Hospital
- Enrollment
- 21
- Primary Endpoint
- progression-free survival
- Status
- Not Yet Recruiting
- Last Updated
- last year
Overview
Brief Summary
This study is a single-arm, open, phase II clinical trial aimed at evaluating the anti-tumor efficacy and safety of paclitaxel polymeric micelles for injection combined with furquintinib as second-line treatment for advanced gastric cancer.
Investigators
Tianshu Liu
Director of Oncology Department
Shanghai Zhongshan Hospital
Eligibility Criteria
Inclusion Criteria
- •1.Age ≥ 18 years ;
- •Histologically confirmed advanced gastric cancer. The first-line systemic treatment containing oxaliplatin and fluorouracil failed. According to RECIST version 1.1, there is at least one measurable lesion;
- •Eastern Cooperative Oncology Group（ECOG）score 0 or 1 ; 4.Expected survival ≥ 12 weeks ; 5.Adequate organ and bone marrow function (no hematopoietic growth factor, blood transfusion or platelet therapy was given within 1 week before the first drug treatment ):
- •Blood routine: leucocyte ≥3.0×109/L, absolute neutrophil count (ANC)≥1.5 ×109/L, platelet count（PLT）≥ 100×109/L, Hemoglobin ( Hb )≥ 9.0 g/dL;
- •Liver function : total bilirubin ≤ 1.5 ×ULN;Alanine aminotransferase(ALT)/aspartate aminotransferase (AST)≤2.5×ULN without liver metastasis ;ALT/AST ≤ 5 ×ULN with liver metastasis;
- •Coagulation function : international normalized ratio (INR)≤1.5×ULN, and activated partial thromboplastin time (APTT) ≤1.5×ULN ;(Investigator judge that INR and APTT should be in the safe and effective treatment range for patients who are undergoing anticoagulant therapy);
- •Renal function : serum creatinine ≤ 1.5×ULN ;
- •Adequate cardiac function, left ventricular ejection fraction (LVEF) \> 50 % detected by two-dimensional echocardiography.
- •6.Understand the research and voluntarily sign the informed consent.
Exclusion Criteria
- •Patients have received clinical trials of other research drugs or research instruments within 28 days before the first study of treatment ;or received anti-tumor treatment including but not limited chemotherapy, radiotherapy (excluding palliative radiotherapy completed at least 1 week before the treatment )and targeted therapy within 2 weeks before the first study of treatment; 2.The toxicity of previous anti-tumor therapy has not returned to the level of 0 or 1 (excluding alopecia ， peripheral neurotoxicity caused by chemotherapy ≤ 2) ; 3.Surgery was performed within 4 weeks before the first treatment (except biopsy) or the surgical incision was not completely healed ;
- •There were ascites requiring drainage or diuretic treatment, or pleural effusion or pericardial effusion requiring drainage or accompanied by shortness of breath within 2 weeks before the first treatment; 5.Symptomatic brain metastasis or spinal cord compression(except for previously treated patients with brain metastases, if the clinical condition was stable within 4 weeks before the first treatment and the imaging evidence did not show disease progression).
- •History of other primary malignant tumors in the past 5 years (except for malignant tumors that have been cured, e,g, basal cell carcinoma, cutaneous squamous cell carcinoma, cervical carcinoma in situ, breast cancer in situ).
- •7.History of HIV, or active bacterial or fungal infection requiring systematic treatment within 14 days before the first treatment .
- •HBV DNA ≥ 104copies / ml or \> 2000IU / ml in the screening period ; 9.Cardiovascular diseases with significant clinical significance, including but not limited acute myocardial infarction, severe / unstable angina, cerebrovascular accident or transient ischemic attack, congestive heart failure (New York Heart Association classification \> 2) within 6 months before enrollment;other arrhythmia treated with drugs(exclude β blockers or digoxin); electrocardiogram repeated detection of QTcF interval ≥ 450 ms.; hypertension failed to be well controlled after antihypertensive drug treatment (systolic blood pressure \> 150 mmHg, diastolic blood pressure \> 100 mmHg ).
- •10.Clinically significant abnormalities in serum electrolyte levels ; 11.Women during pregnancy or lactation ; 12.Fertile but unwilling to accept effective contraception.
Arms & Interventions
Paclitaxel Polymeric Micelles for Injection combined with Fruquintinib Capsules
Fruquintinib Capsules：4 mg / day, orally once daily on days 1-14 in 21-day cycles. If the patient has AE of grade 3 or above, the dose of fruquintinib capsules is reduced to 3 mg / day(dose discontinuation to dose reduction). Paclitaxel Polymeric Micelles for Injection：150mg / m2 intravenously over 3 hours on Days1,8 of each 21-day cycle. Do not need special infusion device. Paclitaxel Polymeric Micelles for Injection and Fruquintinib Capsules are used for 6 cycles. Subsequently, dual-drug or single-drug maintenance therapy was selected according to the tolerance of the patients. Subsequently, Paclitaxel Polymeric Micelles for Injection ( 120mg / m2, if the patient is intolerable, the dose can be reduced to 100mg / m2 ), until occur the disease progress, the intolerant toxicity or the patient withdrawal.
Intervention: Paclitaxel Polymeric Micelles for Injection combined with Fruquintinib Capsules
Outcomes
Primary Outcomes
progression-free survival
Time Frame: 24 months
PFS(Progression-Free-Survival) was the time from randomization until the date of objectively determined progressive disease (PD) or death due to any cause, whichever occurred first.