Polymeric Micellar Paclitaxel for Metastatic Pancreatic Cancer

Inclusion Criteria:

1. Men or women aged 18 to 75 years old (including the critical value).

• 2）Metastatic pancreatic cancer confirmed by histology or cytology.

• 3）Patients who have not previously received any systemic therapy (includingchemotherapy, targeted, and immunotherapy), radiotherapy, surgery, orinvestigational drugs for the treatment of metastatic pancreatic cancer; Patientswho have previously received neoadjuvant or adjuvant chemotherapy could be enrolledif the interval between last treatment and recurrence and metastasis is more than 6months.

• 4）Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.

• 5）Survival is expected to be at least 3 months.

• 6）At least one metastatic lesion (non-lymph node lesions with a major diameter of ≥ 10 mm on CT or MRI and lymph node lesions with a minor diameter of ≥ 15 mm) that ismeasurable according to the Response Evaluation Criteria in Solid Tumors (RECIST,version 1.1) and is amenable to accurate repeated measurement.

• 7）The major organs function well: a) white blood cell count ≥ 3.0 × 10^9/L. b)Hemoglobin ≥ 90.0 g/L. c) Absolute neutrophil count ≥1.5 × 10^9/L. d) Platelet count ≥100 × 10^9/L. e) Total bilirubin ≤1.5 × upper limit of normal range (ULN). f)Alanine aminotransferase (ALT), aspartate aminotransferase (AST) and alkalinephosphatase (ALP) ≤ 2.5 × ULN; For patients with liver metastasis, ALT, AST and ALP ≤ 5 × ULN; ALP ≤ 10 × ULN in patients with bone metastases. g) Serum creatinine (Cr) ≤ 1.5 × ULN or creatinine clearance estimated by CockcroftGault formula ≥50 ml/min. h) International normalized ratio (INR) ≤ 1.5 × ULN and prothrombin time (PT) oractivated partial thromboplastin time (APTT) ≤ 1.5 × ULN.

• 8）Women of childbearing age are required to have a negative pregnancy test at thescreening period and to use a highly effective contraceptive method for 6 monthsfrom the screening period to the last dose. Male participants whose partners arewomen of childbearing age are required to use a highly effective contraceptivemethod for 6 months after the first dose of a trial product until the last dose.

• 9）Patients are able to understand the steps of this trial, are willing to follow theclinical trial protocol to complete the trial, and sign the Informed Consent Form.

Exclusion Criteria:

• 1）Patients who are allergic to the investigational drugs and their analogues, orexcipients.

• 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, skinsquamous cell carcinoma, melanoma in situ, papillary thyroid carcinoma and cervicalcarcinoma in situ, were excluded.

• 3）CNS (central nervous system) or meningeal metastases are known, except for thosewith single brain metastases that are strictly controlled and asymptomatic.

• 4）Patients with tumor liver metastasis exceeding 1/2 of the entire liver duringscreening; or there may be active hepatitis B (HBsAg test positive, HBV-DNA>500IU/ml or research center detection limit [only when the research center limit isabove 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 requiringcurrent 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 decompensatedheart and lung failure, leading to intolerance to chemotherapy.

• 9） Patients with bleeding tendency (e.g., presence of active ulcer lesions instomach, melena and/or hematemesis within 3 months, hemoptysis).

• 10） History of severe cardiovascular and cerebrovascular diseases, including but notlimited to:

1. NYHA (New York Heart Association) class III or IV heart disease;

2. Uncontrollable hypertension (i.e. systolic blood pressure ≥ 160 mmHg, and/ordiastolic blood pressure ≥ 100 mmHg)；

3. Severe cardiac rhythm or conduction abnormalities, such as ventriculararrhythmias requiring clinical intervention, II-III degree atrioventricularblock, etc;

4. QT interval prolongation corrected for heart rate (corrected for QTc intervalusing Fridericia formula, males>450ms, females>470ms);

5. Individuals with significant abnormalities in electrocardiogram with clinicalsignificance;

6. Acute coronary syndrome, congestive heart failure, stroke, or other grade 3 orhigher cardiovascular events occurring within 6 months prior to the firstadministration;

• 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 clinicalintervention 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 thescreening 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 withan investigational nonbiologic agent (administered within the past 30 days or fivehalf-lives, whichever was longer) or an investigational biologic agent (monoclonalor polyclonal antibody) (within the past 4 months or five half-lives, whichever islonger).

• 17）Pregnant or lactating female patients.

• 18）Participants who are judged by the investigator to be unable to follow trialprocedures or who are judged by the investigator to be unfit to participate in thetrial for other reasons.