Polymeric Micellar Paclitaxel for Metastatic Pancreatic Cancer

Exclusion Criteria

• •1）Patients who are allergic to the investigational drugs and their analogues, or excipients.
• •2）Patients who had any other malignant tumors within 5 years before or at present, except those who had been completely cured, such as basal cell carcinoma, skin squamous cell carcinoma, melanoma in situ, papillary thyroid carcinoma and cervical carcinoma in situ, were excluded.
• •3）CNS (central nervous system) or meningeal metastases are known, except for those with single brain metastases that are strictly controlled and asymptomatic.
• •4）Patients with tumor liver metastasis exceeding 1/2 of the entire liver during screening; or there may be active hepatitis B (HBsAg test positive, HBV-DNA\>500 IU/ml or research center detection limit \[only when the research center limit is above 500 IU/ml\]); Active hepatitis C (positive for hepatitis C virus (HCV) antibodies and HCV-RNA \> research center detection limit).
• •5） Human Immunodeficiency Virus test is positive.
• •6）Patients with active, uncontrolled bacterial, viral, or fungal infection requiring current systemic anti-infective therapy.
• •7） Patients who have a history of drug or alcohol abuse prior to screening.
• •8）Patients with severe organic lesions or major organ failure, such as decompensated heart and lung failure, leading to intolerance to chemotherapy.
• •9） Patients with bleeding tendency (e.g., presence of active ulcer lesions in stomach, melena and/or hematemesis within 3 months, hemoptysis).
• •10） History of severe cardiovascular and cerebrovascular diseases, including but not limited to:
• •1. NYHA (New York Heart Association) class III or IV heart disease;
• •2. Uncontrollable hypertension (i.e. systolic blood pressure ≥ 160 mmHg, and/or diastolic blood pressure ≥ 100 mmHg)；
• •3. Severe cardiac rhythm or conduction abnormalities, such as ventricular arrhythmias requiring clinical intervention, II-III degree atrioventricular block, etc;
• •4. QT interval prolongation corrected for heart rate (corrected for QTc interval using Fridericia formula, males\>450ms, females\>470ms);
• •5. Individuals with significant abnormalities in electrocardiogram with clinical significance;
• •6. Acute coronary syndrome, congestive heart failure, stroke, or other grade 3 or higher cardiovascular events occurring within 6 months prior to the first administration;
• •11） Clinically uncontrollable third space effusion, such as pleural effusion, pericardial effusion, peritoneal effusion, etc. If there were no clinical symptoms, small amounts of pleural effusion or ascites that did not require clinical intervention could be enrolled only after strict control.
• •12） serious psychiatric disorders in the past or current.
• •13）Organ transplant recipients.
• •14）Use of the prohibited medications specified in the protocol is planned during the screening and treatment periods.
• •15） Patients with a history of psychotropic drug abuse and unable to quit.
• •16）Before screening, participants have participated in another clinical trial with an investigational nonbiologic agent (administered within the past 30 days or five half-lives, whichever was longer) or an investigational biologic agent (monoclonal or polyclonal antibody) (within the past 4 months or five half-lives, whichever is longer).
• •17）Pregnant or lactating female patients.
• •18）Participants who are judged by the investigator to be unable to follow trial procedures or who are judged by the investigator to be unfit to participate in the trial for other reasons.