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

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.

Interventions

• Drug 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

Primary outcome measures

• progression-free survival [Time frame: 24 months]

Eligibility criteria

Inclusion criteria

\- 1.Age ≥ 18 years ; 2. 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; 3. 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

• 1\. 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 ; 4. 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).

6\. 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 .

8\. 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06706895 · Zhongshan Hospital

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗