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

Launched by SHANGHAI ZHONGSHAN HOSPITAL · Nov 25, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new combination treatment for patients with advanced gastric cancer who have not responded to their first round of treatment. The study is looking at how effective and safe a medication called paclitaxel polymeric micelles for injection is when combined with another drug called fruquintinib. This trial is in the second phase, which means researchers are focusing on understanding how well the treatment works and if it is safe for patients to use.

To participate in this study, patients must be at least 18 years old and have been diagnosed with advanced gastric cancer that has not improved after receiving certain previous treatments. They should also be in reasonably good health, with specific requirements for blood and organ function. Participants can expect to receive the new treatment and will be monitored closely for any side effects. It's important to note that the trial is not yet recruiting participants, so interested individuals will need to wait for the study to start.

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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 ):
• • 1. 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;
• • 2. 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;
• • 3. 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);
• • 4. Renal function : serum creatinine ≤ 1.5×ULN ;
• • 5. 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.