pancreatic cancer
Conditions
Interventions
Trial Arm: Icaritin in combination with gemcitabine and nab-paclitaxel
Sponsors
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1) 18-80 years old. 2) Patients with histologically or cytologically confirmed pancreatic ductal adenocarcinoma (PDAC) disease presenting at Sir Run Run Shaw Hospital, Zhejiang University School of Medicine. 3) Locally progressive or metastatic PDAC according to the 2022 CSCO Guidelines for the Treatment of Pancreatic Adenocarcinoma. 4) No prior systemic therapy. 5) Presence of measurable disease as defined by the Remission Evaluation Criteria in Solid Tumours (RECIST 1.1). 6) Eastern Cooperative Oncology Group (ECOG) PS 0 or 1. 7) Life expectancy of at least 3 months. 8) Adequate organ function (absolute neutrophil count = 1.5 x 109/L; platelet count = 100 x 109/L; creatinine < 1.5 x ULN (upper limit of normal) or creatinine clearance (CRCI) = 60 ml/min; albumin = 30 g/L; total bilirubin < 5 x ULN; aspartate aminotransferase (AST) < 2.5 x ULN; alanine aminotransferase (ALT) < 2.5 x ULN (= 5 x ULN acceptable if liver metastases are present); INR or PT < 1.5 x ULN, APTT < 1.5 x ULN. 9) In case of females of childbearing potential, a negative serum pregnancy test within 7 days prior to the first trial treatment; 10) In the case of females of childbearing potential, or in the case of male subjects whose partners are of childbearing potential, willingness to use a highly effective method of contraception (failure rate of less than 1.0% per year) from the first study treatment until 24 weeks after completion of trial treatment. 11) Have no other serious underlying medical conditions. 12) Voluntarily participate in this study and sign an informed consent form.
Exclusion criteria
Exclusion criteria: 1) Neuroendocrine (carcinoid, islet cell) or pancreatic follicular carcinoma. 2) Untreated active central nervous system metastases or meningeal metastases. 3) Previous treatment of pancreatic cancer with systemic therapies such as targeted, immunotherapy, chemotherapy, and modern herbal medicines with anti-tumour indications, or other therapeutic modalities such as surgery or particle implantation. 4) Surgery for any reason (other than diagnostic biopsy) within 4 weeks of the first dose of trial treatment and/or the subject has not fully recovered from surgery within 4 weeks of the first dose of trial treatment. 5) History of radiotherapy within 3 months of the first dose of trial treatment. No more than 30% bone marrow radiation or extensive radiation should be used within 4 weeks prior to the first dose of trial treatment. 6) History of any second malignancy within the last 2 years. 7) Significant cardiovascular compromise within 12 months prior to the first dose of study drug: e.g., history of congestive heart failure in New York Heart Association (NYHA) class II or higher, unstable angina, myocardial infarction or stroke from a cerebrovascular accident, or cardiac arrhythmia associated with haemodynamic instability; prolongation of the corrected QT (QTc) interval by >480ms. 8) Presence of bleeding or thrombotic disorders or undergoing thrombolytic therapy, coagulation disorders; patients deemed unsuitable by the investigator for participation in this study. 9) Clinically significant haemoptysis or tumour bleeding of any cause within 2 weeks prior to the first dose of study intervention. 10) Patients with uncontrolled epilepsy, history of central nervous system disease or psychiatric disorders, hypertension The investigator will determine whether clinical severity prevents signing of informed consent or affects patient compliance with oral medication. 11) Active autoimmune disease requiring systemic therapy within the past 2 years. 12) May have other concurrent medical conditions that are relative contraindications to this trial. 13) Serious allergic reaction to the active ingredient(s) in this trial. 14) Female patients who are pregnant or breastfeeding, or who do not wish to prepare for pregnancy during the trial. 15) Other medical conditions that, in the opinion of the investigator, interfere with the requirements of the trial in terms of safety or efficacy assessment or treatment compliance. 16) Vulnerable groups, including the mentally ill, cognitively impaired, critically ill, minors, pregnant women, illiterate, etc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival(PFS); | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective remission rate (ORR);Overall survival (OS);Survival rates at 6, 12 and 18 months;Disease Control Rate (DCR);Duration of ongoing remission (DOR);Changes in serum tumour marker levels;safety; | — |
Countries
China
Contacts
Public ContactDefei Hong
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Outcome results
None listed