pancreatic cancer
Conditions
Interventions
Locally advanced unresectable pancreatic cancer:chemotherapy
Sponsors
Fudan University Shanghai Cancer Center
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) Sign the informed consent form. Received a full explanation and understanding of the purpose, content, predicted efficacy, pharmacological effects, and risks of this trial, and the subjects have signed the informed consent form; 2) Target Population a) Locally advanced pancreatic adenocarcinoma confirmed by histopathological or cytology; b) At least one measurable objective lesion according to RECIST1.1 criteria; c) ECOG score of 0-1; d) Expected survival time= three months; e) Willing to comply with study procedures and able to perform treatment (including surgery) and follow-up; f) There are no contraindications to using PD-1, PD-L1, gemcitabine, and paclitaxel for injection (albumin-bound type). 3) Abnormal results of physical examination and laboratory tests a) Hematologic abnormalities are defined as i) absolute neutrophil (ANC) count =1.5×109/L; ii) platelet count (PLT): =80×109/L; iii) Hemoglobin (Hb) level = 90 g/L. b) Abnormal liver function is defined as i) total bilirubin (TBil) levels: 1.5 times the upper limit of normal (ULN) =, ii) aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels = 2.5 times the ULN, =or five times the ULN if liver metastases are present. c) Definition of abnormal renal function: serum creatinine = 1.5 times ULN, or calculated creatinine clearance = 50ml/min. d) Definition of coagulopathy: International normalized ratio (INR) = 1.5 times ULN and prothrombin time (PT) or activated partial thromboplastin time (aPTT) = 1.5 times ULN, unless the subject is receiving anticoagulant therapy. 4) Subjects who are positive for hepatitis B surface antigen (HBsAg) and have a peripheral blood hepatitis B virus deoxyribonucleic acid (HBV-DNA) titer = 1×103 copies/L; If HBsAg is positive and peripheral blood HBV-DNA = 1×103 copy number/L, the subject is eligible for inclusion if the investigator believes that the subject's chronic hepatitis B is in a stable phase and does not increase the subject's risk. 5) Age and reproductive status a) Males and females aged 18-75 years; b) Subjects of childbearing potential must agree to use effective contraception for the duration of the trial; Women of childbearing potential must have a negative serum or urine pregnancy test 24 hours before the start of chemotherapy; c) Females must be non-lactating.
Exclusion criteria
Exclusion criteria: 1) Brain metastases are excluded from target disease; 2) Prior treatment with anti-PD-1 or anti-PD-L1 antibodies; 3) Receipt of any investigational drug within four weeks before the first use of the study drug; 4) Enrollment in another clinical study at the same time, unless it is an observational (non-interventional) clinical study or an interventional clinical study follow-up; 5) Medical history and intercurrent illness a) Uncontrolled medical severe illness that, in the opinion of the investigator, will affect the subject's ability to receive treatment under the study protocol, such as concomitant serious medical diseases, including severe heart disease, cerebrovascular disease, uncontrolled diabetes mellitus, uncontrolled hypertension, uncontrolled infection, active peptic ulcer, etc. b) Have active, known, or suspected autoimmune diseases (including but not limited to uveitis, enteritis, hepatitis, hypophysitis, nephritis, vasculitis, hyperthyroidism, hypothyroidism, and asthma requiring bronchodilator therapy, etc.). Subjects with hypothyroidism who only need hormone replacement therapy and skin conditions that do not require systemic treatment (such as vitiligo, psoriasis, or alopecia) may be enrolled. c) Have an active tuberculosis infection. Patients with active tuberculosis infection within one year before administration, even if they have been treated, should be excluded. Patients with a history of active tuberculosis infection more than one year ago are also excluded unless previous treatment with standardized antituberculosis therapy is demonstrated. d) Previous interstitial lung disease or (non-infectious) pneumonitis requiring oral or intravenous steroid therapy. e) Long-term treatment with systemic hormones (dose equivalent to 10 mg prednisone/day) or any other form of immunosuppressive therapy. Subjects using inhaled or topical corticosteroids may be enrolled; f) Heart disease that is not well controlled, such as: (1) New York Heart Association (NYHA) heart failure above grade 2 (2) Unstable angina pectoris (3) Myocardial infarction occurred within one year (4) Clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention; g) Dementia, altered mental status, or any psychiatric illness that would preclude understanding or giving informed consent or filling out questionnaires. h) History of allergy or hypersensitivity to any of the therapeutic components. i) Malignant tumors within five years, except for adequately treated basal cell or squamous epithelial cell carcinoma of the skin, localized prostate cancer after radical resection, and ductal carcinoma in situ of the breast after radical resection. j) Prior systemic therapy for locally advanced pancreatic cancer. k) Subjects with a prior pathological diagnosis of squamous cell carcinoma (not limited to organs) who have received a taxane-containing regimen as neoadjuvant/adjuvant therapy. l) Subjects with Grade =2 peripheral neuropathy according to CTCAE version 5.0. 6) Positive hepatitis C virus (HCV) antibody or human immunodeficiency virus (HIV) antibody. 7) Active infection requiring systemic therapy. 8) Need to be treated with other anti-tumor drugs. 9) Have received any investigational drug treatment or participated in another interventional clinical trial within 30 days of the screening period. 10) Other conditions that are not suitable for enrollment in t
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR;PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| OS;resection rate;security event; | — |
Countries
China
Contacts
Public ContactYu Xianjun
Fudan University Shanghai Cancer Center
Outcome results
None listed