Pancreatic
Conditions
Interventions
Treatment group:Utidelone injection:30mg/m2/d on day 1-5, intravenously
Sponsors
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) Voluntarily participate in this study and sign the informed consent form. (2) 18-75 years of age. (3) Eastern Cooperative Oncology Group (ECOG) physical status score of 0-1. (4) Expected survival time >= 12 weeks. (5) Histologically or cytologically confirmed advanced pancreatic cancer that is not surgically resectable and not amenable to local treatment should be malignant tumors originating from the pancreatic ductal epithelium, excluding pancreatic neuroendocrine tumors. (6) Failure of at least one prior line of chemotherapy (including but not limited to gemcitabine or 5-FU drugs) for advanced pancreatic cancer.Failure (progression during or within 6 months after completion of neoadjuvant and/or adjuvant therapy; intolerable drug side effects). (7) Previous use of chemotherapeutic agents, molecularly targeted drugs or radical radiotherapy, requiring more than 4 weeks of drug discontinuation and recovery from previous toxicities (NCI-CTCAE 5.0); for those who have received immunotherapy, at least 4 weeks after the end of treatment, and immune. For those who have received immunotherapy, treatment must be completed at least 4 weeks and immune-related adverse reactions recovered to =3.0 × 10^9/L; b. Neutrophil count (ANC) >= 1.5 ×10^9/L; c. Platelet count >= 90 × 10^9/L; d. Hemoglobin >=9.0 g/dL. 2) Liver and kidney function: liver and kidney function tests within 1 week before enrollment (no albumin transfusion within 14 days before screening, based on the normal values of our laboratory) a. Total bilirubin (TBIL) =60 ml/min; e. Left ventricular ejection fraction (LVEF)>=50%; f. QT interval <=480ms. (10) Women of childbearing age should have a negative blood and urine pregnancy test within 7 days prior to enrollment. Male and female subjects of childbearing potential and their sexual partners agree to use reliable contraception [e.g., intrauterine device (IUD) or condom] during and for 1 month after the study treatment period.
Exclusion criteria
Exclusion criteria: (1) Patients with other malignancies (except cured cervical carcinoma in situ, papillary thyroid carcinoma, basal cell carcinoma of the skin or squamous cell carcinoma of the skin) currently or within the past 5 years. (2) Patients who have undergone other antitumor therapy including chemotherapy, radiotherapy, biologic therapy, immunotherapy, or antitumor herbal therapy within 4 weeks prior to enrollment. (3) Patients who have participated in other drug clinical studies within 4 weeks prior to enrollment. (4) Have undergone major organ surgery (excluding puncture biopsy) or significant trauma within 4 weeks prior to enrollment, or require elective surgery during the trial. (5) Known brain metastases or meningeal metastases (including asymptomatic brain metastases or meningeal metastases), suspected central nervous system metastases. Patients need to have cranial MR enhancement + DWI for clarification. (6) Patients with a history of uncontrolled epilepsy, CNS disease, or psychiatric disorders whose clinical severity, in the judgment of the investigator, would prevent signing informed consent or affect patient compliance with treatment. (7) The following conditions within 6 months prior to enrollment: myocardial infarction, severe/unstable angina, NYHA class 2 or higher Myocardial infarction, severe/unstable angina, NYHA class 2 or higher cardiac insufficiency, persistent arrhythmia of grade =2 (according to NCI CTCAE version 5.0), uncontrolled hypertension (>=160/100 mmHg), atrial fibrillation of any grade, symptomatic congestive heart failure, cerebrovascular accident (including transient ischemic attack or symptomatic pulmonary embolism) within 6 months prior to enrollment. (8) Clinically symptomatic plasma cavity effusion (e.g., pleural effusion, peritoneal effusion, pericardial effusion, etc.) that has increased progressively after 2 weeks of conservative medical treatment (excluding drainage). (9) Severe allergy to castor oil, or severe neurological adverse reactions of grade III or higher with previous anti-microtubule drugs. (10) Known peripheral neuropathy>= NCI CTC AE grade 2. However, patients with loss of deep tendon reflexes (DTR) only need not be excluded. (11) Complicated systemic infection requiring treatment (e.g., intravenous antibiotics, antifungal or antiviral drugs according to clinical protocols) within 4 weeks prior to first dose, or unexplained fever >38.5 degrees (except oncologic fever) during screening/before first dose. (12) Active HBV, HCV infection; except for drug-treated stable hepatitis B (DNA titer must not be higher than 500 IU/mL or copy number <1000 copies/ml) and cured hepatitis C (negative peripheral blood HCV RNA test). (13) Those with active tuberculosis, or a history of previous uncontrolled tuberculosis infection with treatment. (14) Known history of positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS). (15) Women who are pregnant or breastfeeding. (16) Vulnerable groups, including persons with mental illness, cognitive impairment, critically ill patients, and illiterate persons. (17) Patients who, in the judgment of the investigator, are unfit to participate in this trial for any reason.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival;Overall survival;Duration of response;Safety; | — |
Countries
China
Contacts
Public ContactWang Xian
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Outcome results
None listed